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LIBRARY GUIDE:

AdvaMed and UL Partnership Courses

AdvaMed & UL Partnership Courses

Page 1T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540 T: 609.627.5300 | W: uleduneering.com | 202 Carnegie Center, Suite 301, Princeton, NJ 08540

The AdvaMed and UL Partnership

Leading device companies have recognized that an unwavering commitment to compliance and quality are key to perennial success. That commitment is demonstrated through senior management dedication, stellar customer service and robust training.

As the exclusive online training partner for compliance solutions to AdvaMed, UL EduNeering brings its years of proven enterprise-wide compliance management experience to the Medical Technology industry. Specialized programs address issues including Quality System Regulations (QSR), regulatory inspections and enforcement, good manufacturing and clinical practices, fraud and abuse, and ethical interactions with Health Care Professionals (HCPs).

UL helps Medical Device companies meet those goals effectively and cost-efficiently. Our web-based technologies, subject matter expertise and experience in adult learning enable organizations to improve employee and supply chain performance, reduce risk, increase operational efficiency, optimize quality and demonstrate consistent compliance with regulatory requirements and corporate standards. Our solutions, available in more than 30 languages, are designed to support the needs of global enterprises as well as emerging companies.

Overview: Table of Contents

Course Listed by Content Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Course Descriptions:A Guide to ISO 13485 – The Quality Management System for Medical Devices (DEV50) . . . . . 4A Tour of the FDA (PHDV60) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4An Introduction to ISO 13485 – The Quality Management System for Medical Devices (DEV48) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Approach to Computerized Systems Validation and Compliance (ISPE02) . . . . . . . . . . . . . . . . . . . . 4Basics of the AdvaMed Code (MDSM01) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Basic Radiation Awareness (EHS05) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Bioresearch Monitoring (BIMO): Introduction (BIMO001) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6Bloodborne Pathogens – Health C are Workers (EHS09) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6cGMPs for Combination Products (PHDV93) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Complaint Management for Medical Device Manufacturers (DEV46) . . . . . . . . . . . . . . . . . . . . . . . . 7Compliance Improves Business Performance (ADVAMED02) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Computerized Systems Inspections in the Medical Device Industry (ISPE04) . . . . . . . . . . . . . . . . . 7Design Control Regulations for Medical Device Manufacturers (DEV40) . . . . . . . . . . . . . . . . . . . . . . 8Essentials of an Effective Calibration Program (PHDV75) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Ethical Third Party Sales and Marketing Intermediary (“SMI”) Relationships (MDMS06) . . . . . . 8EU Medical Device Directive Part I: Introduction (MDD01) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8EU Medical Device Directive Part II: Speci�c Procedures (MDD02) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9EucoMed Guidelines on Interactions with Healthcare Professionals (MDSM04) . . . . . . . . . . . . . . 9Failure Investigations for Medical Device Manufacturers (DEV45) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9FDA 483s: Inspectional Observations (FDA30) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10FDA Establishment Inspection (EI) (FDA32) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10FDA Establishment Inspection Report Writing (FDA26) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10FDA Good Guidance Practices (GGPs) (FDA21) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Field Examinations (FDA28) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Global Regulatory Strategy and Planning Process (DEV54) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92) . . . . . . . . . . . . . . . . .11Gowning for Sterile Manufacturing (PHA63) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Handling a Product Recall (PHDV64) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Handling a FDA Inspection (PHDV74) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12HIPAA and Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01) . . . . . . .12ICH Q7A: Introduction and Quality Management (ISPE05) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13ICH Q7A: Resources and Materials Management (ISPE06) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Implementing an Equipment Quali�cation Program (PHDV88) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Import Operations 1: Background (FDA37) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Import Operations 2: The Process (FDA42) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Import Operations 3: Other Activities (FDA43) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15


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Introduction to GMPs (PHA38) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Introduction to Medical Device Compliance (MDSM05) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Introduction to Quality System Regulations (QSRs) (DEV43) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16MDR Regulation 1: Overview and General Provisions (FDA63) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16MDR Regulation 2: Device User Facility, Importer and Manufacturer Reporting Requirements (FDA65) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16MDR Regulation 3: Requirements for Individual Adverse Event Reports (FDA66) . . . . . . . . . . . .16Medical Device Filings: 510(k), PMA, and IDE (DEV53) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Medical Device Packaging, Labeling and Distribution (DEV41) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Operating Room Conduct (PHA68) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Part 11: Electronic Records and Signatures – Application (FDA61) . . . . . . . . . . . . . . . . . . . . . . . . . . .18Part 11: Electronic Records; Electronic Signatures (FDA31) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Physician Payment Sunshine Act (PHSM11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Principles of Aseptic Processing (PHDV71) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Principles of Auditing (PHDV69) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19QS Regulation 1: Overview and General Provisions (QSR01). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19QS Regulation 2: Quality System Requirements (QSR02) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19QS Regulation 3: Design Controls (QSR03) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20QS Regulation 4: Document and Purchasing Controls (QSR04). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20QS Regulation 5: Identi�cation and Traceability; Production and Process Controls (QSR05) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20QS Regulation 6: Acceptance Activities; Nonconforming Product (QSR06) . . . . . . . . . . . . . . . . . . .20QS Regulation 7: Corrective and Preventive Action (QSR07) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution and Installation (QSR08) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21QS Regulation 9: Records (QSR09) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22QS Regulation 10: Servicing; Statistical Techniques (QSR10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22QS Regulation 11: Application and Inspection of QS Regulation (QSR11) . . . . . . . . . . . . . . . . . . . .23Quality System Inspection Technique (QSIT) (DEV42) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23QSIT 1: Beginning the Inspection (FDA50) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23QSIT 2: The Management Controls Subsystem (FDA51) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24QSIT 3: Design Controls Subsystem (FDA52) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24QSIT 4: The Corrective and Preventive Actions Subsystem (FDA53) . . . . . . . . . . . . . . . . . . . . . . . . . .25QSIT 5: The Production and Process Controls Subsystem (FDA54) . . . . . . . . . . . . . . . . . . . . . . . . . . .25Recalls of FDA Regulated Products (FDA24) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Reporting Adverse Events for Medical Devices (MDMS02) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Review of Basic Statistical Techniques (DEV44) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Requirements for Computerized Systems Validation and Compliance (ISPE01) . . . . . . . . . . . . . .27Risk Management 1: Key Concepts and De�nitions (FDA29) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27The Approval Process for New Medical Devices (DEV47) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27



GMP/QSR:A Guide to ISO 13485 – The Quality Management System for Medical Devices (DEV50)A Tour of the FDA (PHDV60)An Introduction to ISO 13485 – The Quality Management System for Medical Devices (DEV48)Approach to Computerized Systems Validation and Compliance (ISPE02)Basic Radiation Awareness (EHS05) cGMPs for Combination Products (PHDV93) Complaint Management for Medical Device Manufacturers (DEV46) Computerized Systems Inspections in the Medical Device Industry (ISPE04) Design Control Regulations for Medical Device Manufacturers (DEV40) Essentials of an Effective Calibration Program (PHDV75) EU Medical Device Directive Part I: Introduction (MDD01) EU Medical Device Directive Part II: Speci�c Procedures (MDD02) Failure Investigations for Medical Device Manufacturers (DEV45)GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92) Gowning for Sterile Manufacturing (PHA63) Handling a Product Recall (PHDV64) ICH Q7A: Introduction and Quality Management (ISPE05) ICH Q7A: Resources and Materials Management (ISPE06) Implementing an Equipment Quali�cation Program (PHDV88) Introduction to GMPs (PHA38)Introduction to Quality System Regulations (QSRs) (DEV43)Medical Device Packaging, Labeling and Distribution (DEV41) Operating Room Conduct (PHA68)QS Regulation 1: Overview and General Provisions (QSR01)QS Regulation 2: Quality System Requirements (QSR02) QS Regulation 3: Design Controls (QSR03) QS Regulation 4: Document and Purchasing Controls (QSR04) QS Regulation 5: Identi�cation and Traceability; Production and Process Controls (QSR05) QS Regulation 6: Acceptance Activities; Nonconforming Product (QSR06) QS Regulation 7: Corrective and Preventive Action (QSR07)QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution and Installation (QSR08)QS Regulation 9: Records (QSR09)QS Regulation 10: Servicing; Statistical Techniques (QSR10)QS Regulation 11: Application and Inspection of QS Regulation (QSR11)Quality System Inspection Technique (QSIT) (DEV42) Review of Basic Statistical Techniques (DEV44) Requirements for Computerized Systems Validation and Compliance (ISPE01)

Courses Listed by Functional Area:



Corporate Compliance:

Basics of the AdvaMed Code (MDSM01) Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03)Compliance Improves Business Performance (ADVAMED02)Ethical Third Party Sales and Marketing Intermediary (“SMI”) Relationships (MDMS06) EucoMed Guidelines on Interactions with Healthcare Professionals (MDSM04) HIPAA and Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01)Introduction to Medical Device Compliance (MDSM05) Physician Payment Sunshine Act (PHSM11)Reporting Adverse Events for Medical Devices (MDMS02)

Clinical:

Bioresearch Monitoring (BIMO): Introduction (BIMO001)

US FDA:

FDA 483s: Inspectional Observations (FDA30) FDA Establishment Inspection (EI) (FDA32) FDA Establishment Inspection Report Writing (FDA26) FDA Good Guidance Practices (GGPs) (FDA21) Field Examinations (FDA28)Handling a FDA Inspection (PHDV74) Import Operations 1: Background (FDA37) Import Operations 2: The Process (FDA42) Import Operations 3: Other Activities (FDA43) MDR Regulation 1: Overview and General Provisions (FDA63) MDR Regulation 2: Device User Facility, Importer and Manufacturer Reporting Requirements (FDA65) MDR Regulation 3: Requirements for Individual Adverse Event Reports (FDA66) Part 11: Electronic Records and Signatures – Application (FDA61) Part 11: Electronic Records; Electronic Signatures (FDA31)QSIT 1: Beginning the Inspection (FDA50) QSIT 2: The Management Controls Subsystem (FDA51) QSIT 3: Design Controls Subsystem (FDA52)QSIT 4: The Corrective and Preventive Actions Subsystem (FDA53) QSIT 5: The Production and Process Controls Subsystem (FDA54) Recalls of FDA Regulated Products (FDA24) Risk Management 1: Key Concepts and De�nitions (FDA29)

Global Market Access:Global Regulatory Strategy and Planning Process (DEV54)Medical Device Filings: 510(k), PMA, and IDE (DEV53) The Approval Process for New Medical Devices (DEV47)



Course Descriptions:In Alphabetical Order

FDA-regulated industries must work closely with the FDA to comply with industry regulations and create safe and effective products. But how well do your employees know the FDA? “A Tour of the FDA” serves as an excellent introduction to its organizational structure and gives an overview of the different enforcement actions available to this critical Agency. Take a virtual ‘tour’ of the FDA and learn about the function of each Center. Afterwards, explore different actions the Agency may take in order to achieve compliance.

Topics include:

• FDA background• The organizational structure of the FDA• Office of the Commissioner• Office of Regional Affairs• The six main program Centers• Enforcement actions:

• Informal enforcement• Formal enforcement

A Tour of the FDA (PHDV60)

This course, the second in a three-part series, describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals and medical devices that are required to meet FDA regulations. It outlines the kind of organization, policies and procedures, and plans the FDA expects a manufacturing company to establish. This course draws on current industry good practice. Though it also draws on FDA medical device guidance, this course is not intended to describe an approach to developing software that subsequently becomes part of a medical device.

Prerequisite:

• Computerized Systems Validation and Compliance

Topics include:

• Description of a suitable framework for successful validation and compliance

• Planning and reporting requirements for computerized systems validation

• Selecting a validation strategy• Ongoing activities that the user firm should perform to ensure

continuing compliance

Approach to Computerized Systems Validation and Compliance (ISPE02)

This course is designed to describe the basic requirements for ISO 13485 – the international quality management system for medical devices. The requirements of the standard apply to the methods used in and the facilities and controls used for, the design and development, production, installation and servicing of medical devices.

Topics include:• Process Approach

• Quality Management

• Management’s Role

• Managing Resources

• Planning

• Design and Purchasing

• Production

• Monitoring and Analysis

A Guide to ISO 13485 – The Quality Management System for Medical Devices (DEV50)

In this course, you will be able to identify why ISO 13485 is different from other quality system regulations and recognize management’s role in its implementation. You will also be able to recognize the main clauses of ISO 13485:2003 and why they are critical in terms of an overall quality system. Lastly, you will be able to identify how to prepare to implement ISO 13485:2003.

Topics include:• Process Approach

• Preparation

• Clauses in ISO 13485

An Introduction to ISO 13485 – The Quality Management System for Medical Devices (DEV48)



The Advanced Medical Technology Association (AdvaMed) represents companies that develop, produce, manufacture and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities (Medical Technologies) in order to enable patients to live longer and healthier lives.

AdvaMed recently approved a major update of its Code of Ethics on Interactions with Health Care Professionals (the Code). It is crucial for all Medical Technology companies to understand the guidelines and how they impact interactions with Health Care Professionals (HCPs).

The term “Health Care Professional” is defined broadly in the Code and includes persons and entities involved in the provision of patient care and in the decisions to purchase, lease or recommend a medical technology. These individuals may include purchasing agents, physician practice managers and management within group purchasing organizations.

It is important to remember that some HCPs are also government employees. More restrictive legal restrictions may apply to such individuals.

After completing this course you will understand how the AdvaMed Code guides your interactions with HCPs. This updated Code contains important revisions and new provisions that include: Further clarification and distinguishing of appropriate and inappropriate interactions between HCPs and representatives of Medical Technology companies; A new Code compliance section that will list companies that certify their adoption of the Code (available on the AdvaMed website); A prohibition on providing entertainment or recreation to HCPs, as well as a prohibition on gifts; Guidelines for entering into royalty arrangements with HCPs; Parameters for the provision of evaluation and demonstration products; An expanded section addressing the provision of objective reimbursement, coverage and health economics information to HCPs.

Topics include:

• AdvaMed Code • Company-Conducted Product Training and Education • Third Party Educational Conferences and Business Meetings • Consulting Arrangements • Evaluation and Demonstration Products • Modest Meals, Prohibition on Entertainment and Gifts • Coverage and Reimbursement • Grants and Donations

Basics of the AdvaMed Code (MDSM01)

The general public often thinks radiation exposure only occurs in areas displaying “Caution: Radiation” or “Danger: Radiation” signs. Actually, in addition to exposure in certain work places, each of us is exposed to natural radiation each day of the year. This course presents information about the types of natural and manmade (ionizing) radiation, as well as where radiation originates, its health effects, principles of protection and components of an effective Radiation Protection Program.

Basic Radiation Awareness (EHS05)



The Massachusetts Department of Public Health promulgated the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Regulation 105 CMR 970.000 to implement provisions to promote cost containment, transparency and efficiency in the delivery of quality health care. The regulation is intended to benefit patients, enhance the practice of medicine and ensure that the relationship between manufacturers and Health Care Professionals (HCPs) does not interfere with the independent judgment of those HCPs.

Although the 105 CMR 970.000 regulation has similar provisions to the recently revised AdvaMed and Pharmaceutical Research and Manufacturers of America (PhRMA) Codes of Ethics, it imposes a number of additional restrictions on Pharmaceutical and Medical Device manufacturing companies’ (including distributors’) interactions with HCPs. The regulation also requires these companies to annually disclose certain payments to HCPs. These changes will directly affect how you and your company conduct business with Massachusetts-licensed HCPs.

The Massachusetts Regulation has the full force of law, including significant fines for noncompliance. Your company may be required to certify to the Massachusetts Department of Public Health that it has a Code of Conduct in compliance with the regulation, has adopted training programs and has procedures for conducting investigations of noncompliance. Your company must also provide the department with the contact information of the compliance officer responsible for certifying compliance with the regulation.

Topics include:

• Applicability• Requirement Prescriber Data• Contracts, Audits and Meals • Continued Medical Education (CME) • Other Payments • Disclosure of Payments

Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03)

This is the first in a series of courses that provide an overview of the FDA’s Bioresearch Monitoring (BIMO) program and the methods and techniques used in conducting and reporting Nonclinical Laboratory, Clinical Investigator, Institutional Review Board (IRB), Sponsor/Monitor and in vivo Bioequivalence inspections. This course provides an overview and historical perspective of the FDA’s BIMO program.

Topics include:

• Evolution of the FDA’s regulatory history • BIMO terminology • The purpose of the FDA’s BIMO program• Regulations and expectations for the FDA’s BIMO program• How the FDA implements the clinical BIMO program

Bioresearch Monitoring (BIMO): Introduction (BIMO001)

Health Care workers face the risk of exposure to bloodborne pathogens every day. These pathogens include hepatitis, AIDS and other infectious diseases. In this course, participants will learn the sources of bio-hazardous substances and the routes of transmission and symptoms of bloodborne diseases. This course also covers the proper techniques and equipment for personal protection, the actions to be taken following a possible exposure and the components of an effective Exposure Control Plan.

References: OSHA 29 CFR Part 1910.1030 – Bloodborne PathogensThis course incorporates materials from The HSE Group, Inc. and J. Fleming.

Bloodborne Pathogens – Health C are Workers (EHS09)



After completing this course, you will be able to recognize the four different types of combination products. You will understand the scope of the new regulation in 21 CFR Part 4, and how to comply with each of the drug, device, and biological product provisions. You will understand the role of the Office of Combination Products (OCP), how post-marketing modifications are made, and how to report post-marketing adverse events.

Topics include:• Background

• Final Rule

• Meeting compliance

• The Office of Combination Products

• Post-approval modi�cations

cGMPs for Combination Products (PHDV93)

This course has been designed by International Society of Pharmaceutical Engineers (ISPE) and UL in cooperation with the FDA/Office of Regulatory Affairs (ORA) to assist FDA inspectors in recognizing the critical aspects of computerized systems in the Medical Device industry. The course explains how computerized systems are used in the medical device manufacturing process and provides an approach to inspecting these systems. This course does not cover the detailed review of software that forms part of a medical device; it covers only inspection of systems that automate part of the device production process or part of the quality system.

Prerequisites:

• Requirements for Computerized Systems Validation and Compliance

• Approach to Computerized Systems Validation and Compliance

Topics include:

• How computerized systems are used in the Medical Device industry

• How an investigator should approach computerized systems• The focus of the investigator’s review

Computerized Systems Inspections in the Medical Device Industry (ISPE04)

Compliance with anti-corruption policies and legislation not only helps avoid the economic and societal consequences of corruption worldwide; it makes good business sense as well. This course introduces you to anti-corruption policies and legislation as well as the reasons behind them. It also shows how compliance brings benefits to your business.

Topics include:

• Why Business Ethics, Codes of Ethics and Compliance Matter• The Business Case• The APEC KL Principles for Medical Technology Sector

Codes of Ethics

Compliance Improves Business Performance (ADVAMED02)

This course will educate the learner about the importance of properly responding to reports of alleged medical device problems. The learner will be able to apply the knowledge acquired to handle complaint events in a manner that is compliant with FDA regulations.

Topics include:

• The FDA’s definition of a complaint• Effective complaint handling systems, including Corrective and

Preventative Action (CAPA)• Complaint file maintenance• Investigating a complaint• Requirements of the Medical Device Reporting (MDR)

regulation• Analysis of complaint data

Complaint Management for Medical Device Manufacturers (DEV46)



Injuries, fatalities or major class action suits filed against the manufacturer can result when products are produced with out-of-calibration equipment. When lives are at stake and a company’s reputation is in the balance, equipment must always be operating to its precise specifications. This course is designed to help the learner identify key concepts of calibration and recognize the importance of calibration reference standards and GMP calibration requirements in order to ensure an effective calibration program.

Topics include:

• Calibration• Calibration standards• GMP requirements for the calibration program• Essential elements for a calibration program

Essentials of an Effective Calibration Program (PHDV75)

The European Union (EU)’s Medical Device Directive (MDD) serves as the basis for the authorization to sell medical devices in the EU market. Every employee needs to become familiar with the rules developed by regulatory authorities to keep the market flowing while maintaining accountability for Medical Device manufacturers.

This training course provides basic components of the EU Medical Device Directive, as well as the definitions and classifications that describe the devices that fall under the Directive.

Topics include:• History and Approaches

• Quality System: Learn the eight elements of the quality system, as de�ned in the Directive

• Classes of Medical Devices: Learn more about the 18 rules described in Directive 92/43/EEC Annex IX

EU Medical Device Directive Part I: Introduction (MDD01)

This course explores third party sales and marketing intermediary relationships. It discusses the key regulatory risks associated with sales and marketing with third parties, depicts how an effective compliance program can assist a company in mitigating regulatory risks, and describes essential elements of an effective compliance program.

Topics Include:• De�nition

• Compliance Program

• Risk Areas

• Scenarios

• Conclusion

• Challenge

Ethical Third Party Sales and Marketing Intermediary (“SMI”) Relationships (MDMS06)

This course introduces the learner to FDA design control regulations by providing basic information about the key procedures followed during the design and development of a product. The design plan requires documentation of training, planning validation, design transfer and changes, formal review, a design history file and human factors.

Topics include:• What are design control regulations?

• What is a design and development plan?

• What is design input?

• What is design output?

• What is design review?

• What is the purpose of design veri�cation?

• What is the purpose of design validation?

• What is design transfer?

• How is design change control achieved?

Design Control Regulations for Medical Device Manufacturers (DEV40)



This course will explore what a failure is, the regulatory and practical aspects of investigations and the elements that make these investigations effective. It will also provide guidance on conducting a comprehensive investigation and on developing corrective actions that prevent future recurrences. Product or process failures are often unavoidable events encountered in Medical Device manufacturing. How you handle these failures, however, can be significant in your ability to maintain a state of control in operations and prevent future failures. The success of a failure investigation can often be tied to whether the investigation was comprehensive enough to actually identify the root cause of the event.

After completing this course, you will be able to recognize the basic definition of failures. You will be able to identify when a failure investigation should occur and the documentation required. You will also be able to describe the basic elements of a comprehensive failure investigation and the steps for management review and follow-up.

Topics include:

• Medical device product failure and GMP requirements• Failure investigations• Identifying the root cause of a failure• Corrective and Preventive Actions (CAPA)• Follow up on the CAPA• Documenting and communicating failures, investigations • and CAPA

Failure Investigations for Medical Device Manufacturers (DEV45)

This course focuses on the EucoMed Guidelines on Interactions with Health Care Professionals (HCPs). The mission of EucoMed is to improve patient and clinician access to modern, innovative, and reliable medical technology. The goal of this course is to familiarize EucoMed members with the guidelines of their many interactions with HCPs.

Topics include:• Key Principles

• Education and Meetings

• Consulting, Arrangements, Gifts and Billing

• Donations and Grants

EucoMed Guidelines on Interactions with Healthcare Professionals (MDSM04)

The European Union (EU)’s Medical Device Directive serves as the basis for the authorization to sell medical devices in the EU market. This training course provides specific information regarding the EU Medical Device Directive and Council of Europe (CE) marking of medical devices, including how to assess conformity with the MDD, how to document conformity as well as incidents and events and how to conduct post-market research and follow-up.

Topics include:• Conformity Assessment: How to determine in which class a

device belongs

• Clinical Evaluation: De�nition and clinical data requirements

• Technical File: What must be documented, including description, speci�cations, standards, etc.

• Risk Management: Based on EN ISO 14971, what the risk management process should include, including analysis, evaluation, control and post-production information

• Post-Market Surveillance (PMS): What manufacturers should consider before establishing and operating a PMS system

• Follow-Up: Criteria to consider before establishing Post-Market Clinical Follow-up (PMCF)

EU Medical Device Directive Part II: Specific Procedures (MDD02)



This course is designed to familiarize FDA staff with the history of the FDA 483 (Inspectional Observations) form, it’s purpose and when it is issued to the inspected firm’s management. After completing this course you will be able to identify the kinds of inspectional observations that are included on an FDA 483 and how to annotate it during the discussion with management.

Topics include:

• Purpose of an FDA 483• Objectionable conditions• Reportable conditions• Commandments• Annotation

FDA 483s: Inspectional Observations (FDA30)

The FDA’s findings during establishment inspections prevent violative and potentially dangerous products from reaching the consumer. It is for this reason that all FDA inspectors, investigators and analysts understand the fundamentals of performing an FDA establishment inspection. This course identifies the FDA’s statutory authority in conducting establishment inspections. After completing this course, you will recognize the basics of FDA establishment inspections including the procedures for preparing, initiating, conducting, and concluding an inspection.

Topics include:

• FDA establishment inspections • Conducting establishment inspections• Preparing for an establishment inspection• Procedures for initiating an inspection• Handling inspection refusals• Observations during an inspection• Procedures for gathering evidence• Interviewing facility personnel• Procedures for concluding the inspection

FDA Establishment Inspection (EI) (FDA32)

This course will familiarize FDA staff members who will conduct establishment inspections with the purpose of the Establishment Inspection Report (EIR), what should be included in the report and how to make the report readable. The course will also provide an introduction into the new “Turbo EIR” concept as a work in progress. After completing this course you should understand why the FDA prepares reports using a standard format, what that format is and how to make your reports readable. You will also be able to identify additional formats and alterations for the EIR.

Topics include:

• Scope• Preparation• Readability• Additional formats

FDA Establishment Inspection Report Writing (FDA26)



This course on FDA Good Guidance Practices (GGPs) explains which Agency documents are considered guidance documents. It also explains why we have GGPs, their legal effect, how they are developed and implementation. After completing this course, you will be able to describe the history, development, issuance and use of Agency guidance. You’ll also learn how and why GGPs were established.

This training fulfills a statutory requirement for the FDA.

Topics include:

• Guidance documents• GGPs origins• Implementing GGPs• Issuing guidance documents• How guidance documents differ from regulations

FDA Good Guidance Practices (GGPs) (FDA21)

Field examinations help to ensure the safety, purity and effectiveness of products that are released for public use. Field exams cover the entire spectrum of FDA-regulated products, including foods, animal and human drugs and devices, biological products, electronic products for compliance with the Radiation Control Standards and cosmetics for label standards. This course is designed to familiarize individuals with the “what, why and when” of conducting examinations of products while performing inspections, sample collections or surveillance activities.

In this course you will learn the basics of field examinations, the purpose and when they must be conducted. In addition, you will also learn about the types of field examinations, the equipment commonly used and how these examinations are conducted.

Topics include:

• A field examination• When to conduct a field examination• Types of equipment used when conducting a field examination• Conducting a field exam

Field Examinations (FDA28)

This course is about creating the strategy and planning documents that help companies align the development of new products with the regulatory submission process for those products. Along with the regulatory plan, a company’s regulatory strategy describes the overall regulatory approach and the specific tactical steps required to meet regulatory objectives.

Global Regulatory Strategy and Planning Process (DEV54)

This course focuses on the regulatory attention devoted to supply chain management, and references U.S. FDA’s 2013 draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements, in which the agency recommends that companies define, establish, and document the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs

Topics include:• Challenges

• FDA Response

• Company Improvements

GMP Updates: Supply Chain Quality and Emerging Compliance (PHDV92)



Companies undergo product recalls for various problems; it could happen to any company. A product recall is probably the most difficult and stressful situation that can be encountered in this industry. Because product recall can be critical, you need to understand what it is and how to handle it.

This lesson defines product recalls and explains their impact on the manufacturer, FDA requirements and enforcement when dealing with a product recall, and the basic steps for handling a recall.

Topics included:

• Product recalls• Steps in conducting a recall• Roles and responsibilities during a product recall• Effect of a recall on a company• Who a company must communicate with during a recall

Handling a Product Recall (PHDV64)

This course reviews the basics of handling an FDA inspection of a Pharmaceutical and Medical Device manufacturing facility. The course will clarify the roles and responsibilities of personnel during an inspection with an emphasis on being prepared and maintaining a positive, professional relationship.

Topics include:

• Personnel conduct • Inspection types • The process • Records • Samples and photos • Enforcement • End of inspection

Handling a FDA Inspection (PHDV74)

This course provides a short summary of the HIPAA Privacy Rule and describes how HIPAA affects the detailing and customer support activities of medical device sales representatives.

Topics include:• De�nition

• Effects of HIPAA

• Products & Software

• Assistance & Training

• Patient Issues

HIPAA and Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01)

In this course you will be able to identify important sources and types of contamination in a manufacturing environment, recognize the importance of health issues and personal hygiene and describe the staged entry and use of cleanrooms. You will also learn to identify important practices and procedures for proper gowning.

Prerequisites:

• Principles of Aseptic Processing• Principles of Sterilization

Topics include:

• Why gowning is important• Types of contamination• Preparation in gowning rooms• Gowning basics and procedures

Gowning for Sterile Manufacturing (PHA63) EU



This is the second in a series of courses designed to instruct on GMPs for Active Pharmaceutical Ingredients (APIs), as set out by the International Conference on Harmonisation (ICH) Q7A Guideline. This course covers qualifications for personnel, requirements for buildings used in API manufacturing, considerations for API manufacturing equipment, and materials management. Learners should have a working knowledge of current GMPs for drug products as set out in CFR 21 Parts 210 and 211. Learners should also have a basic understanding of chemical and biological processes used in the manufacture of APIs. After completeing this course, you will be able to recognize materials management and warehousing and distribution procedures.

Prerequisite:

• ICH Q7A: Introduction and Quality Management

Topics include:

• Personnel qualifications• Buildings and facilities requirements used for

API manufacturing• Process equipment requirements used for

API manufacturing• Purpose of materials management• Storage/Distribution

ICH Q7A: Resources and Materials Management (ISPE06)

Equipment qualification serves as the foundation for several currently recognized Health Care industry compliance requirements, such as analytical method, process, cleaning and automated systems validation. A well-developed and established equipment qualification program allows a company to meet cGMP requirements and save on operational costs at the same time. This course is designed to provide an introductory overview of the equipment qualification requirements that apply to the Pharmaceutical, Biotechnology and Medical Device industries.

After completing this course, you will be able to define equipment qualification, identify the importance of equipment qualification, recognize the GMP requirements in this area and identify the steps that must be followed in order to successfully implement equipment qualification.

Topics include:

• Importance of equipment qualification• Equipment qualification protocol• Design Qualification (DQ)• Installation Qualification (IQ)• Operational Qualification (OQ)• Performance Qualification (PQ)• Legacy Equipment Qualification (LEQ)

Implementing an Equipment Qualification Program (PHDV88)

This is the first in a series of courses designed to instruct on cGMPs for active pharmaceutical ingredients (APIs), as set out by the ICH Q7A Guideline. This course covers the Introduction to ICH Q7A and Quality Management for API manufacture.

After completing this course, you will be able to describe the purpose of the Q7A Guideline and how it fits in with current regulatory expectations and practices in the United States – especially in the context of the FDA’s systems-based inspections program, 7356.002F. You will also be able to recognize the basic terminology and applications of Q7A and the principles of an effective quality management system for API manufacture.

Prerequisites:

The learner should have a working knowledge of current GMPs for drug products as set out in the Code of Federal Regulations, CFR 21 Parts 210 and 211, as well as a basic understanding of chemical and biological processes used in the manufacture of APIs.

Topics:

• What is Q7A• How APIs differ from drug products• When Q7A guidelines apply to the API manufacturing process• The purpose of quality management• Key production activity that ensures API quality• Why a formal change control system is needed• What complaints and recalls share in common

ICH Q7A: Introduction and Quality Management (ISPE05)



This is the first in a series of three courses that addresses FDA import and export programs, procedures and policies. Its purpose is to introduce the FDA import program and to familiarize the learner with the application of the law to products that are offered for entry into the US and intended for export from the US. This course includes information on key references, laws and regulations related to imports. Learners should complete five courses in the Food and Drug Law series (FDA Jurisdictions, Criminal Acts Violations, Imports and Exports, Judicial Actions and Prohibited Actions), as well as the courses Sample Collection and Field Examinations, before taking this course.

Topics include:

• The FDA approach to ensuring imported products meet US public health standards

• The FD&C Act and the treatment of foreign and domestic products

• Sections of the FD&C Act on imports and exports• Sections of 21 CFR that address imports and exports of FDA-

regulated products• Sections of 19 CFR that address customs enforcement of

imports and exports• Sections of 18 USC that address criminal activity associated

with imports and exports• Guidance and policy documents that provide more information

about import and export operations

Import Operations 1: Background (FDA37)

The second in the series, this course addresses pre-entry activities, types of entries, admissibility decisions and resources that help the FDA make sound admissibility decisions. The course also addresses the evaluation of entries, laboratory analysis and what happens to products after examination. After completing this course, you will recognize how the FDA regulates imported products and decides which products to admit. You will also recognize the process of import operations and how the FDA enforces regulations if problems arise.

Prerequisites:

• Import Operations 1: Background• Food and Drug Law courses: (FDA Jurisdictions, Criminal Acts

Violations, Imports and Exports, Judicial Actions and Prohibited Actions)

• Sample Collection • Field Examinations

Topics include:

• How the FDA regulates imported products before entry into the US

• Types of entries for imported products• How the FDA makes entry decisions• What resources are available to assist in determining

admissibility• Entries requiring further evaluation• Entries requiring sample analysis• Entries that have undergone further evaluation• Enforcement tools available to the FDA

Import Operations 2: The Process (FDA42)



This is the last in a three-course series that addresses FDA import and export rograms, procedures and policies. This course addresses how import filers participate in the FDA’s electronic review system, how the FDA identifies and removes violative imports and how domestic and import operations can help the FDA identify potential problems. The course also addresses the responsibilities the FDA shares with other government agencies and the provisions that allow the export of products that do not comply with the FD&C Act.

Prerequisites:

• Import Operations 1, Background and 2, The Process• Food and Drug Law courses: (FDA Jurisdictions, Criminal Acts

Violations, Imports and Exports, Judicial Actions and Prohibited Actions)

• Sample Collection • Field Examinations

Topics include:

• How import filers participate in Operational and Administrative System for Import Support (OASIS)

• Who the FDA shares information with to identify violative imported products in the US market

• How theFDA regulates exports• Export certificates• Who the FDA shares responsibility with

Import Operations 3: Other Activities (FDA43)

In this course, you’ll examine the history of Good Manufacturing Practices (GMPs) and explore the importance of training, as well as quality control and personal responsibilities. In addition, you’ll discover the importance of documentation and tracking practices.

Topics include:

• Procedures and documentation• Responsibilities • Contamination control • Inspections

Introduction to GMPs (PHA38)

This course provides high-level introduction and background regarding the compliance environment affecting the Medical Device industry. These topics are especially important in the industry, as the development of medical device products involves a close collaboration between the industry and Health Care Professionals (HCPs), and their use may require the interaction and skill of medically-trained personnel.

This course is designed to make employees aware of pertinent laws, regulations and industry guidance that regulate the Medical Device industry.

Topics include:

• FDA Regulations• The Federal Anti-Kickback Statute• The Office of the Inspector General (OIG) Compliance • Program Guidance• AdvaMed Code of Ethics• Foreign Corrupt Practices Act (FCPA)• False Claims Act• State Ethics and Compliance Legislation

Introduction to Medical Device Compliance (MDSM05)



Employees play an active part in ensuring the quality of the product. This interactive program provides employees with an overview of the FDA’s current Quality Systems Regulation (QSR)for medical devices. Mastery of these concepts will provide employees with a good understanding of how the QSR affects operations in manufacturing facilities. This program emphasizes the elements of a Quality System that help to ensure products are safe and effective and that manufacturing operations are compliant with current medical device Good Manufacturing Practice (GMP).

Topics include:

• Management responsibilities• Design controls• Document controls• Process controls• Purchasing controls• Corrective and preventive actions• Device labeling and packaging procedures• Training

Introduction to Quality System Regulations (QSRs) (DEV43)

This course discusses important terms crucial to understanding the Medical Device Reporting (MDR) regulation. It also discusses the MDR requirements as they relate to user facilities, importers and manufacturers. It explores the requirements for MDR procedures and event files.

Topics Include:• De�nitions

• User Facility

• Importers

• Manufacturer

• Event Files

MDR Regulation 2: Device User Facility, Importer and Manufacturer Reporting Requirements (FDA65)

This course identifies how user facilities, importers and manufacturers report adverse events. It explores the proper forms to use to report adverse events, as well as the timeframes for reporting. It also discusses when it is not necessary to report an event.

Topics Include:• Reporting

• MEDWATCH

• Deadlines

• Codes

• Exceptions

MDR Regulation 3: Requirements for Individual Adverse Event Reports (FDA66)

This course discuses the origin and evolution of the Medical Device Reporting (MDR) regulation. It describes the key characteristics of the MDR and its preamble, as well as the key terms used in the MDR. It also explores to whom the MDR applies and who can be exempt. The MDR regulation provides one mechanism for the FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goal of the regulation is to detect and correct product problems in a timely manner.

Topics include:• Origin

• Characteristics

• Key Terms

• Compliance

• Foreign Manufacturers

• Exemptions

MDR Regulation 1: Overview and General Provisions (FDA63)



Mistakes or mix-ups in the critical areas of product packaging, labeling and distribution can pose a danger to the consumer. This course provides you with information on current packaging and labeling requirements specified by the Quality System Regulation (QSR).

Prerequisites:

A basic understanding of QSRs for Medical Device and Equipment manufacturers (21 CFR 820), quality control procedures and quality principles.

Topics include:• What is medical device labeling?

• Safe and effective labeling and misbranding

• Label control

• Proper packaging procedures

• Distribution requirements for devices

Medical Device Packaging, Labeling and Distribution (DEV41)

This course addresses all aspects of Operating Room (OR) conduct. The course will cover important, general information about the hospital environment and staff, how to behave prior to and upon arrival at the hospital and how to dress for the OR. The course also covers the OR setting, protocols and restrictions for entering patient care areas, the roles of company representatives and hazards that are present in a hospital and in the operating room.

Topics include:• Protocols

• OR Attire

• Representatives

• Procedure Support

• Hazards

• Aseptic Technique

Operating Room Conduct (PHA68)

This course covers the premarket approval and notification processes for medical devices in the U.S. As a result of the 1976 Act, FDA now requires specific device submissions and the appropriate agency review in order to market new or modified products in the U.S. This course will provide an overview of the different submission processes and give you information on how to successfully complete them for your products. After completing this course, you will have a good overview of the essential elements of the 510(k), PMA, and IDE filing processes for medical devices under FDA.

Medical Device Filings: 510(k), PMA, and IDE (DEV53)



The principle purpose of 21 CFR Part 11 is to ensure that when electronic records and signatures are used, they meet the minimum requirements of trustworthiness, reliability and compatibility with the FDA’s mission of public health and safety. This interactive lesson is designed to introduce you to the regulatory requirements for electronic records and electronic signatures, as well as FDA expectations for compliance. You will learn specific Part 11 requirements that govern the use of electronic records and signatures as well as FDA enforcement of Part 11.

Topics include:

• Part 11• Basic requirements for electronic records• Security requirements for electronic records• Basic requirements for electronic signatures• Controls for electronic signatures• FDA enforcement of Part 11

Part 11: Electronic Records; Electronic Signatures (FDA31)

This course will provide the learner with an understanding of how to implement Part 11 and what it means in terms of the FDA’s enforcement policy for 21 CFR Part 11, Electronic Records; Electronic Signatures. The course discusses the Guidance for Industry; Part 11, Electronic Records; Electronic Signatures – Scope and Application.

Topics include:

• Meeting expectations• Records• Security• Electronic Signatures• System Documentation• Audit Trails

Part 11: Electronic Records and Signatures – Application (FDA61)

This course provides the basics of the Physician Payment Sunshine Act (“Sunshine Law”), which was passed in 2010 as part of comprehensive health reform legislation. The law requires certain businesses to comply with specific transparency requirements. Specifically, those businesses must report payments to physicians and teaching hospitals as well as ownership interests by those physicians.

The main purpose of the law is to provide patients with enhanced transparency into the relationships their Health Care Providers have with Life Science and Medical Technology manufacturers.

After taking this course, learners will understand which companies are required to report, what is a “covered recipient,” and what types of payments need to be reported.

Topics include:• Companies Required to Report

• Payment and Other Transfer of Value

• Information Required on the Transparency Report

• Physician Ownership Reporting

• Exclusions

• Penalties

Physician Payment Sunshine Act (PHSM11)



This program focuses on the purpose and conduct of internal and external quality audits. It discusses the purpose of conducting audits and focuses on the benefits to be derived if audits are conducted properly. It begins with a discussion on establishing an audit program to achieve internal GMP compliance. The lesson is on the actual preparation, conduct and follow-up associated with an internal audit. Finally, the importance of establishing corrective action and follow-up and how these aspects of the audit program can yield opportunities and quality improvements will be illustrated.

Topics include:

• Audits• Types of audits• Benefits of performing an audit• Preparing for an audit• Performing an audit• Audit closeout

Principles of Auditing (PHDV69) EU

This course introduces the Quality System Regulation (QSR) (21 CFR Part 820) – a framework of basic requirements for manufacturers of finished medical devices. The course covers the history of the regulation, as well as its requirements, scope and key terms. The course also discusses the manufacturer’s responsibility for a quality system under this regulation.

QS Regulation 1: Overview and General Provisions (QSR01)

The second in a series of Quality System Regulation (QSR) courses, it focuses on the management responsibility, quality auditing and personnel requirements of 21 CFR Part 820, Subpart B. The QSR provides a framework of basic requirements for manufacturers of finished medical devices.

Prerequisite:

• QS Regulation 1: Overview and General Provisions

QS Regulation 2: Quality System Requirements (QSR02)

Because microbiological (bacteria, molds and fungi) and particulate contamination can potentially cause serious health problems in animals and humans, it is vital that sterile products be manufactured, filled and packaged in an aseptic environment. This lesson will address the general principles and practices necessary to assure product sterility and safety related to aseptic processing. It will also address the principles of GMP regulations as aplicable.

Topics include:

• Aseptic processing• Controlling the aseptic processing environment• Employee requirements for aseptic processing• Preparing components for sterile products• Media fill• Environmental monitoring programs

Principles of Aseptic Processing (PHDV71) EU



The third in a series of Quality System Regulation (QSR) courses, it addresses design control requirements of the QSR.

Prerequisite:

• QS Regulation 1: Overview and General Provisions • QS Regulation 2: Quality System Requirements

QS Regulation 3: Design Controls (QSR03)

The fourth in a series of Quality System Regulation (QSR) courses, this course focuses on the Document Controls requirements of 21 CFR Part 820, Subpart D and the Purchasing Controls requirements of 21 CFR Part 820, Subpart E. The QSR provides a framework of basic requirements for manufacturers of finished medical devices.

Prerequisite:

• QS Regulation 1: Overview and General Provisions • QS Regulation 2: Quality System Requirements • QS Regulation 3: Design Controls

QS Regulation 4: Document and Purchasing Controls (QSR04)

The fifth in a series of Quality System Regulation (QSR) courses, it focuses on Identification and Traceability (21 CFR Part 820, Subpart F) and Production and Process Controls (21 CFR Part 820 Subpart G). The QSR provides a framework of basic requirements for manufacturers of finished medical devices.

The purpose of the Production and Process Controls requirements of the QSR (21 CFR 820.70, 21 CFR 820.72, 21 CFR 820.75) is to ensure that manufacturers produce devices that conform to their specifications. Where any deviations from specifications could occur during manufacturing, process control procedures must describe the controls necessary to ensure the devices will conform to their specifications. Process control procedures also help to ensure consistency in manufacturing.

After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the identification, traceability, production and process control requirements of the QSR.

Prerequisite:

• Learners should have completed QS Regulation courses 1-4.

QS Regulation 5: Identification and Traceability; Production and Process Controls (QSR05)

The sixth in a series of Quality System Regulation (QSR) courses, it focuses on Acceptance Activities (21 CFR Part 820 Subpart H) and Nonconforming Product (21 CFR Part 820 Subpart I). The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices.

Prerequisite:


QS Regulation 6: Acceptance Activities; Nonconforming Product (QSR06)



This course is the eighth in a series of Quality System Regulation (QSR) courses. It focuses on Labeling and Package Control (21 CFR Part 820 Subpart K) and Handling, Storage, Distribution and Installation (21 CFR Part 820 Subpart L). The QSR provides a framework of basic requirements for manufacturers of finished medical devices. The requirements of the QSR relative to the handling,storage, distribution and installation of medical devices are intended to help ensure that medical device mixups, damage, deterioration, contamination or other adverse effects do not occur.

After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the labeling, packaging control, handling, storage, distribution and installation requirements of the QSR.

Prerequisite:


Topics include:

• Key Terms • Label Integrity • Labeling Operations • Handling/Storage Areas • Control and Distribution • Device Installation

QS Regulation 8: Labeling and Package Control; Handling, Storage, Distribution and Installation (QSR08)

The seventh in a series of Quality System Regulation (QSR) courses, it focuses on Corrective and Preventive Action (21 CFR Part 820 Subpart J). The QSR provides a framework of basic requirements for manufacturers of finished medical devices. The intent of 21 CFR 820.100 is to correct or prevent poor practices, not simply to correct or prevent bad product. Correction and prevention of unacceptable quality system practices should result in fewer nonconformities related to product.

Compliance with the corrective and preventive action requirements of the QSR will allow a firm to monitor, identify and react to existing product and quality system problems, as well as indicators of potential problems. These activities will help manufacturers identify opportunities to improve their products and quality system, as well as protect consumers by initiating field actions where necessary. After completing this course, you’ll be familiar with a manufacturer’s responsibilities relative to the corrective and preventive action requirements of the QSR.

Prerequisite:


QS Regulation 7: Corrective and Preventive Action (QSR07)



The ninth in a series of Quality System Regulation (QSR) courses, it focuses on Records (21 CFR Part 820 Subpart M). The QSR provides a framework of basic requirements for manufacturers of finished medical devices. One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of Medical Device manufacturers) is the “Establish Test.” The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically) and implement.” Records play a vital role in the FDA’s ability to confirm that procedures have been appropriately implemented and, on a broader scope, that an adequate and effective quality system has been established and maintained by the firm being inspected.

After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the records requirements of the QSR.

Prerequisite:• Learners should have completed QS Regulation courses 1-8.

Topics include:• General Requirements

• Device Master Records

• Device History Records

• Quality System Records

• Complaint Records

• Investigations

• Complaint Unit

QS Regulation 9: Records (QSR09)

The 10th in a series of Quality System Regulation (QSR) courses, it focuses on Servicing (21 CFR Part 820 Subpart N) and Statistical Techniques (21 CFR Part 820 Subpart O). The QSR provides a framework of basic requirements for manufacturers of finished medical devices.

Statistical techniques may be employed to fulfill a number of QSR requirements. Where statistical techniques are used, manufacturers must establish procedures for identifying their validity.

After completing this course, you will be familiar with a manufacturer’s responsibilities relative to the servicing and statistical techniques requirements of the QSR.


Topics include:• Key Terms

• Servicing Requirements

• Analysis

• Statistical Techniques

QS Regulation 10: Servicing; Statistical Techniques (QSR10)



This is the 11th and final course in the series of Quality System Regulation (QSR) courses. The QSR provides a framework of basic requirements for manufacturers of finished medical devices. This course focuses on the application and inspection of QSR requirements within a Medical Device manufacturer’s quality system.

During inspections, the FDA will assess whether a manufacturer has established procedures and followed requirements that are appropriate under the current state-of-the-art manufacturing of the specific device.

After completing this course, you will be familiar with the application and interrelationship of QSR requirements within a Medical Device manufacturer’s quality system. You will also be familiar with the basic concepts of the Quality System Inspection Technique (QSIT), which is the inspection process currently used by the FDA to conduct Level 2 Baseline (Comprehensive) quality system inspections.


Topics include:• Key Terms

• Seven Subsystems

• Subsystems and QSIT

QS Regulation 11: Application and Inspection of QS Regulation (QSR11)

Manufacturing companies within the Biomedical industry are subject to routine inspections of their quality systems by the FDA. The FDA investigator(s) audits four major quality subsystems, which include: Management Controls, Design Controls, Corrective and Preventive Actions and Production and Process Controls. Quality System Inspection Technique (QSIT) is a “top-down” approach to evaluating a quality system. You will become familiar with the key objectives that an investigator will address when reviewing each subsystem. The subsystem approach focuses on the elements that are key to meeting the requirements of the Quality System Regulation (QSR).

Topics include:• Assuring documents are in a state of compliance

• Inspectional Objectives for each subsystem:

• Management Controls

• Design Controls

• Corrective and Preventative Actions (CAPA)

• Production and Process Controls (P&PC)

Quality System Inspection Technique (QSIT) (DEV42)

This is the first in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). This course provides guidance for inspecting medical device manufacturers against the Quality System Regulation, 21 CFR Part 820. After completing this course, you will be able to recognize the origin and scope of QSIT. You will also recognize the basic concepts associated with how to sample records for review during a QSIT inspection and report your findings (if necessary) in an Establishment Inspection Report (EIR).

Topics include:• Scope

• Other considerations

• Sampling

• Reporting

QSIT 1: Beginning the Inspection (FDA50)



This is the third in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting Medical Device manufacturers against the Quality System Regulation (QSR), 21 CFR Part 820. This course will cover the inspectional objectives related to the design controls subsystem.

Prerequisites:

• QSIT 1: Beginning the Inspection, and QSIT 2: The Management Controls Subsystem

• Level I New Hire Investigator Certi�cation

• Employees should also review The IOM (as it pertains to the inspection of Medical Device manufacturers), CP 7382.845 “Inspection of Medical Device Manufacturers,” 21 CFR Part 820 – Quality System Regulation and The Guide to Inspection of Quality Systems

Topics include:• Beginning to inspect the Design Controls subsystem

• The design plan review

• The inputs and outputs of the design process

• Assessing acceptance criteria and design veri�cation

• Design validation

• Completing the Design Controls subsystem inspection

QSIT 3: Design Controls Subsystem (FDA52)

This is the second in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation (QSR), 21 CFR Part 820. This course will cover the inspectional objectives related to the management controls subsystem.

Prerequisites:• QSIT 1: Beginning the Inspection



Topics include:• Discussion of each of the seven Management Controls

Inspectional Objectives

QSIT 2: The Management Controls Subsystem (FDA51)



This is the fourth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting Medical Device manufacturers against the QSR, 21 CFR Part 820. This course will cover the inspectional objectives related to the Corrective and Preventive Actions subsystem.

Prerequisites:

• QSIT 1: Beginning the Inspection, QSIT 2: The Management Controls Subsystem and QSIT 3: The Design Controls Subsystem



Topics include:• Procedures

• Problems

• Received data

• Failure investigations

• Actions

• After actions

QSIT 4: The Corrective and Preventive Actions Subsystem (FDA53)

This is the fifth in a series of courses designed to instruct on the Quality System Inspection Technique (QSIT). The series provides guidance for inspecting medical device manufacturers against the Quality System Regulation (QSR), 21 CFR Part 820. This course covers the inspectional objectives related to the Production and Process Controls subsystem.

Prerequisites:

• QSIT 1: Beginning the Inspection, QSIT 2: The Management Controls Subsystem, QSIT 3: The Design Controls Subsystem and QSIT 4: The Corrective and Preventive Actions Subsystem



Topics include:• Selecting a process for review

• How selected process is controlled and monitored

• How to proceed if the process is/was not operating within speci�ed limits

• How to con�rm the validation of a process when the results cannot be fully veri�ed

• Software and personnel

QSIT 5: The Production and Process Controls Subsystem (FDA54)



Because recalls of FDA-regulated consumer products have continued to increase on an annual basis, the monitoring of recalls of potentially hazardous consumer products is one of the most important activities performed by FDA personnel. This course helps you recognize the FDA’s definition of a product recall and the contents of a Recall Letter, as well as the types, depth and classification of a recall and the responsibilities of FDA personnel during a product recall.

Topics include:• Product recalls

• Factors leading to product recalls

• Classifying product recalls

• Recall Letter

• Responsibilities of FDA personnel during a recall

• Recall audit check

Recalls of FDA Regulated Products (FDA24)

The FDA has the authority to oversee the manufacture of medical devices. The FDA requires manufacturers, importers and user facilities to file Medical Device Reports (MDRs) so that adverse events can be detected and corrected quickly.

Congress enacted legislation requiring manufacturers to report to the FDA all device-related deaths, serious injuries, and certain malfunctions because numerous reports over the years have shown there is widespread underreporting. This underreporting resulted in injuries affecting public health which could not be traced by the FDA.

After completing this course, you will be able to identify what a MDR is and the types of reports that exist. You will also recognize a company’s requirements for reporting adverse events for medical devices.

Topics Include:• De�ning an Adverse Event

• Types of Reports

• Internal Procedures

• Documentation/Recordkeeping

• Filling Out an MDR

Reporting Adverse Events for Medical Devices (MDMS02)

This course will explore the proper use of statistical techniques as they apply to Medical Device manufacturing. More than just a set of mathematical tools, the use of statistics in Medical Device manufacturing is now expected and regulated by the FDA in the Quality System Regulation (QSR), Subpart O, Statistical Techniques.

Topics include:• De�nition

• Data Analysis

• Histograms

• Variability

Review of Basic Statistical Techniques (DEV44)



This course describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals and medical devices. It does not cover the detailed requirements of 21 CFR Part 11, except the requirement for systems to be validated. Even though it draws upon medical device guidance, it is not intended to cover all the requirements of producing software that subsequently becomes part of a medical device.

Topics include:• Computerized or automated systems

• Regulations addressing the requirements for validating computerized systems

• Three types of validation

• How software differs from hardware

• Guiding principles for computerized systems validation and compliance

• Installation Quali�cations (IQ), Operational Quali�cations (OQ) and Performance Quali�cations (PQ) as related to computerized systems validation

• FDA expectations for validation activities and documentation

Requirements for Computerized Systems Validation and Compliance (ISPE01)

This course provides key concepts and definitions necessary to understanding Risk Management. The course focuses on Risk Management as it applies to the FDA and its regulated industries. This course is also designed to provide an understanding of Risk Management as defined by the International Organization for Standardization (ISO). You’ll be able to define risk and related terms. You will be able to identify the ways risk can be expressed, differentiate between safety and risk and describe the criteria the FDA uses to judge safety for different types of products. You will also learn the risk management process steps.

Topics include:• De�ning risk

• Calculating and expressing risk

• How the FDA relates risk to safety

• Risk management

Risk Management 1: Key Concepts and Definitions (FDA29)

This course gives an overall view of the development process for admitting a new medical device into the marketplace. After completing this course, you will be able to list the major steps in new device development. You will also be able to define an IDE and PMA. You will be able to identify the purpose and requirements of clinical studies. In addition you will also be able to recognize key information about the classification of medical devices and the role of the FDA in the approval of medical devices for the marketplace.

Topics include:• How medical devices are classi�ed

• Approval process

• Investigational Device Exemption (IDE)

• Clinical studies

• Pre-market approval application (PMA)

The Approval Process for New Medical Devices (DEV47)

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About UL EduNeering

UL EduNeering is a business line within UL Life & Health’s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people.

UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire®.

For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our glo bal quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives.

Since 1999, under a unique partnership with the FDA’s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA’s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute.

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