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Virtual Training: (EN) ISO 14971:2019 Risk Management for Medical Devices21st – 22nd October 2020 Thai Version
About the Virtual TrainingISO 14971 is an ISO standard for the application of risk management to medical devices.
This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation.
EN ISO 14971:2012 has been harmonized with respect to the three European Directives associated with medical devices (Medical Devices, In-vitro Diagnostic Devices and Active Implantable Devices) through the three ‘Zed’ Annexes (ZA, ZB & ZC). This allows the standard to be aligned with the directives and provide a strong framework for the analysis of risks associated to patients, environment, users and equipments.
This 2 day special (EN) ISO 14971:2019 Risk Management training program is intended as an introductory course to enable participants to have a basic understanding of Risk Management for Medical Devices which latest update to new version in 2019 recently.
Agenda � Overview, update change in version 2019 � Risk management planning � Risk analysis, hazard and harm � Risk estimation and risk evaluation � Risk control measures and residual risk evaluation � Post-production Information � Risk management file � Overview of the change � Examination
Benefits from attending the training
Who should attend
Participants will be provided with basic understanding on the requirements of (EN) ISO 14971:2019, the ISO standard which specifically addresses the concerns of Risk Management for medical devices.
– To learn why are we moving from a directive to a regulation, including understanding the background to the changes.
– To understand what the new regulation is trying to achieve. Its key objectives and purpose.
– To identify what the important changes are and their relevance to you as a manufacturer.
Managers, Engineers, Executives, Supervisors of various departments: Quality Assurance, Production, Regulatory Affairs, Laboratory, Logistics, Purchasing, and Members of the Risk management Team.
About the Speaker
Khun Parawee DolsookSenior Auditor Medical Health Service, TÜV SÜD ThailandKhun Parawee Dolsook is responsible in leading the Medical Health Service Division, in TÜV SÜD Thailand and contributing to the division strategic management and growth of TÜV SÜD’s market share for Medical Health Services. He is a recognised Lead Auditor for various schemes, including ISO 9001, ISO 13485, MDD, MDR, MDSAP.
He has the sense of business acumen and well-honed leadership skills, with over a decade of experience relating to manufacturing, research & development and under his belt.
Khun Parawee started his career with Molnlycke Health Care (Thailand) Ltd., where he was responsible for quality assurance leader of medical device products being manufactured by the company. His role was to ensure that the product conformed to the desired requirement and quality attributes. He has a great career path during the work experience in company in promotion to work globally in a Research and Development Department in a role of Assistant Product Care Manager to contribute the new medical device implementation project launch to the market.
Khun Parawee Dolsook holds a Master’s Degree in Business Administration, Major in Marketing Management (MBA) from Ramkhamhaeng University, a Bachelor’s Degree in Industrial Technology Science, Major in Petrochemical and Polymeric Material from Silapakorn University. And, a Bachelor’s Degree in Science, Major in Occupational Health and Safety from Sukhothai Thammathirat University.
ProgrammeDay 1
Day 2
Time Programme
09:00 – 10:30 Module 1: Overview, update change in version 2019
10:30 – 10:45 Break
10:30 – 11:00 Work Shop I: Risk Management Planning
11:00 – 12:00 Module 2: Risk Analysis
12:00 – 13:00 Lunch Break
13:00 – 13:30 Work Shop II: Risk Analysis; Hazard and Harm
13:30 – 14:15 Module 2 (cont)
14:15 – 14:30 Break
14:30 – 15:30 Module 3: Risk Evaluation
15:30 – 16:15 Work Shop III: Risk Estimation and Risk Evaluation
16:15 – 16:30 Q&A
Time Programme
09:00 – 09:15 Review of Day 1
09:15 – 10:30 Module 4: Risk Control
10:30 – 10:45 Break
10:45 – 11:30 Work Shop IV: Risk Control Measures and Residual risk evaluation
11:30 – 12:00 Module 5: Post-Production Information and Work shop V Post
12:00 – 13:00 Lunch Break
13:00 – 13:30 Module 6: Risk Management File
13:30 – 14:15 Module 7: An overview on the changes
14:15 – 14:30 Breaks
14:30 – 16:00 Examination (Paper test)
16:00 – 16:15 Q&A
TÜV SÜD (Thailand) Ltd. 111 Moo 9, Thailand Science Park, Paholyothin Rd. Klong 1, Klong Luang, Pathumthani 12120 Tel. +66 2 5648041 Fax. +66 2 5648042 [email protected] www.tuv-sud.co.th
How to Register
Please Complete the application form below with the training course payment and send an email to our team
by 16th October 2020• MS. Suphatcha Sangkhom Tel: +66 2 564-8041 (extension 129) / HP: +66 81 849-2254 / Fax: + 66 2 564-8042
E-mail: [email protected]
• MS. Ananya Nakkliang Tel: +66 2 564-8041 (extension 129) / HP: +66 62 592-0552 / Fax: + 66 2 564-8042
E-mail: [email protected]
Company Name:Number of
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Company Address:
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Website: Tel: Fax:
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Job Title: HP:
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Training DetailsDate : 21st – 22nd October 2020 (Wednesday & Thursday)
Time : 09:00 am. to 04:30 pm.
Venue : Virtual Training (Microsoft Teams)
Training Fee : THB 5,000 Regular fee
Special Fee : THB 4,500 Applicable for TÜV SÜD Thailand’s ISO 13485 Certification Customer
Remarks:
• Training Fee as above excludes vat 7%
• Please see the payment details as next page
Virtual Training of ISO 14971:2019 Risk Management for
Medical Devices
Date: 21st – 22nd October 2020
Registration Form
04
Detail for payment
Please kindly see below
Account Name: TÜV SÜD (Thailand) Limited
Account Number: 406 - 002274 - 5
Account Type: Saving
Bank Name: SIAM COMMERCIAL BANK PUBLIC COMPANY LIMITED (SCB)
Branch name: Thammasat University Hospital
Tax No.: 0 13554400502 7
Contact Person:Ms. Patchara Wongwipak / Tel: 02-5648041 # 114 / Fax: 02-5648042
E-mail: [email protected]
For withholding
tax as following:
TUV SUD (Thailand) Limited
111 Moo 9, Paholyothin Road, Klong 1, Klong Luang, Pathumthani 12120
Book Bank:
TÜV SÜD (Thailand) Ltd.
111 Moo 9, Thailand Science Park, Paholyothin Rd. Klong 1, Klong Luang, Pathumthani 12120
Tel. +66 2 5648041 Fax. +66 2 5648042 E-mail: [email protected] www.tuv-sud.co.th