cgmp university - gmp training and proactive quality management | compliance resolution

7/29/2019 cGMP University - GMP training and Proactive Quality Management | Compliance resolution

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INSTRUCTOR LEAD SEMINARS.


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COURSE #0001: PRINCIPLES OF QUALITY BY DESIGN(QbD) FOR

GENERIC DRUG MANUFACTURERS

Quality should be designed into the product andprocess that manufactures the product


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INTRODUCTION

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Starting in January 2013, the U.S. Food and DrugAdministration (FDA) expect generic drug

manufacturers to implement Quality by Design

(QbD) into their Abbreviated New Drug

Applications (ANDA). Soon all Pharmaceutical manufacturers will be

required to implement QbD. Unfortunately,

professionals in most companies struggle with the

QbD concept.

This seminar teaches attendees how to apply QbD

principles in product design and manufacturing


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WHO WILL BENEFIT


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The class is designed for the following personnel:

Quality Engineers

Manufacturing Engineers Process Engineers

Regulatory personnel

Product development Engineers

Managers of companies that

manufacture generic drugs


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WHAT YOU WILL LEARN:

Attendees will learn the following:

The FDAs current thinking about pharmaceutical productdesign and approval

Integration of ICHQ6, ICHQ8,ICHQ9,and ICHQ10 into QbDICHQ11 requirements for QbD

The risk based pharmaceutical and microbiologic product andprocess design

Use of scientifically based, and statistically sound decisions in

product and process developmentUse of scientific and statistical tools to design products and

processes

Methods for risk assessment

The concept of design space



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Location and date:

Date and location


WHERE? WHEN?

1.Sheraton Hotel, San Francisco

International Airport,CA

November 26th-27th 2012

2.Doublee Tree Hotel,Philladelphia,PA

March 25th

-26th

2013


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The Cost for this two day handson seminar is $1575

Space is limited: Register on theseminar tab on our website at :

http//www.cgmpuniversity.com



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COURSE #0002 : PRINCIPLES OF SUPPLIERQUALITY MANAGEMENT

Supplier Quality management involves supplier evaluation, supplier

selection, supplier Qualification ,supplier management and supplierrelations.


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INTRODUCTION


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Supplier Quality Management poses a seriousthreat to Quality management in FDA regulated

industries because most processes in

manufacturing are outsourced

This class teaches attendees principles governingSupplier Quality Management including material

Qualification, supplier Qualification, and supplier

management

The class also covers supplier Quality

Agreements, Supplier corrective Action, supplier

Audits and the ASL.


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The class is designed for the following personnel:

Quality Engineers

Supplier Quality Engineers

Supply chain personnel

Quality managers

Product development Engineers

WHO WILL BENEFIT10



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WHAT YOU WILL LEARN


Supplier Qualification process

Supplier Quality management life cycle

Roles and responsibilities of Quality and supplychain in supplier Quality management

Elements of the supplier Quality agreement

How to perform a supplier audit Supplier performance matrix and the ASL

Relationship between the SCAR system andCAPA.



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TARGET INDUSTRIES

The class is designed for professional in the followingindustries:

Medical device Pharmaceutical industries

Biologics

Cellular therapy

Dietary supplements



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Location and date:

Date and location


WHERE? WHEN?


Airport, California

April 08th-09th 2013

2.Double Tree,Philadelphia May 20th

-21st

2013


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Space is limited: Register on theseminar tab on our website at:http//www.cgmpuniversity.com



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Change control is a risk management tool that protects the organization

against waste, variation in product and processes, regulatory exposure andproduct liability


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INTRODUCTION


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Change control is a very complicated process.Failure to control the effects of a proposed change

can lead to product liability, product recalls and

waste

The class is design to approaches change controlfrom a system and product life cycle from design

to retirement

The key principles of risk assessment and impact

assessment are covered in detail

Tools for impact assessment and risk assessment

are taught


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WHO WILL BENEFIT


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1.Change control managers

2.Regulatory affairs personnel

3.Product design personnel

4.Purchasing/supply chain personnel

5.Change control administrators

6.Quality Engineers

7.Manufacturing Engineers


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WHAT YOU WILL LEARN


The change control life cycle

Change classification: minor, moderate, andmajor

Regulatory requirements change control

How to perform impact assessment

How to perform Quality riskManagement(QRM)

How to perform risk assessment

Risk assessment tools



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INDUSTRIES TARGET

The class is designed for professionals in thefollowing industries:

Pharmaceutical manufacturing

Medical device

Cellular therapy

Blood banking Dietary supplements



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Location and date:

Date and location


WHERE? WHEN?


International Airport.

July 22 nd-23rd 2013

2. Double Tree,Philladelphia,PA September 23

rd

-24

th

2013


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Space is limited: Register on theseminar tab on our website at:http//www.cgmpuniversity.com



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For more information about registration FOR OUR WORLDRENOWNED seminars and webinars contact us:

1. Email: [email protected]

2.Toll: 1800-396-39913.Office: (408)-459-GMP

mailto:[email protected]:[email protected]


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AVASA HOTEL HYDERABAD INDIA


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NEW DELHI HILTON INDIA


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SAN FRANCISCO,USA

cgmp university - gmp training and proactive quality management | compliance resolution

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