21 CFR Part 820 Quality System Regulation and FDA cGMP Requirements for Medical Devices: 2-Day In-Person Seminar

By: Frank Ried, Founder and Director of Ried Q&C Consulting Sdn. Bhd.
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Course Description:

The medical device industry is highly regulated due to the product risk to health. The US FDA as the leading regulator in the world requires medical device companies’ compliance to the 21 CFR Part 820, Quality System Regulation (QSR) which specifying current Good Manufacturing Practices (cGMP) for medical devices. Medical device manufacturers selling their goods to US must be compliant from the start of production of the medical device, for high class devices even starting from the design stage. The FDA is checking 21 CFR Part 820 compliance with FDA inspections, whereby the timing and frequency of inspection can vary from 6-12 month after 510k approval up to 5 years after 510k approval and later every 3-5 years. The frequency and inspection decision depend on the criticality of the medical device and compliance history of the medical device/medical device manufacturer. This course will help medical device manufacturers to identify compliance gaps, to set up a sustaining FDA compliant Quality Management System and to prepare for FDA inspections.

Learning Objectives:

This course will provide participants with an overview of the FDA and intention of the 21 CFR Part 820, current requirements of the 21 CFR Part 820, working knowledge in application to their organization as well as ability to prepare and host a FDA inspection.

  • Background of 21 CFR Part 820
  • Quality Management System (prerequisites and what to be considered)
  • Quality System Regulation (guidance about subparts A to O)
  • Resources and Links
  • Quality System Inspection Technique (QSIT)
  • Implementation of Quality System Regulation
  • How to get ready for FDA Plant Inspections

Who will Benefit:

All executives and managers and also quality personnel – anyone who may involve in the implementation and execution of this Quality System Regulation.

  • Senior Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Compliance Professionals
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Document Control Specialists
  • IT Managers and Associated Staff
  • R&D Managers
  • Operations Managers
  • Production Managers and Supervisors

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 08.00 AM - 08.59 AM: Registration and Meet & Greet.
  • 09.00 AM - 09.30 AM:
    • Seminar objectives review, expectations and scope.
    • Pre-Test
  • 09.30 AM - 10.30 AM: Background and QMS prerequisites
  • 10.30 AM - 10.45 AM: Coffee Break
  • 10.45 AM - 12.30 PM: Quality System Regulation (guidance about Sub-Parts A to O)
  • 12.30 PM - 01.30 PM: Lunch
  • 01.30 PM - 03.00 PM: Quality System Regulation (guidance about Sub-Parts A to O) – con’t
  • 03.00 PM - 03.15 PM: Coffee Break
  • 03.15 PM - 04.00 PM: Quality System Regulation (guidance about Sub-Parts A to O) – con’t
  • 04.00 PM - 04.30 PM: Resources and Links
  • Day Two (8:30 AM – 4:30 PM)
  • 08.00 AM - 08.59 AM: Registration and Meet & Greet.
  • 09.00 AM - 10.00 AM:
    • Recap from 1st day
    • Implementation of Quality System Regulation
    • Maintaining compliance to 21 CFR Part 820
  • 10.00 AM - 10.30 AM: Quality System Inspection Technique (QSIT)
  • 10.30 AM - 10.45 AM: Coffee Break
  • 10.45 AM - 12.30 PM: Quality System Inspection Technique (QSIT) – con’t
  • 12.30 PM - 01.30 PM: Lunch
  • 01.30 PM - 03.00 PM: The FDA Inspection Process / How to get ready for FDA Plant Inspections
  • 03.00 PM - 03.15 PM: Coffee Break
  • 03.15 PM - 04.00 PM: The FDA Inspection Process / How to get ready for FDA Plant Inspections - con’t
  • 04.00 PM - 04.30 PM:
    • Recap of both days
    • Post Test
    • Questions & Answers
  • Meet Your Instructor

    Casper Uldriks_90x112
    Frank Ried
    Founder and Director of Ried Q&C Consulting Sdn. Bhd

    Frank Ried holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Furthermore, Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality), respectively by DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

    Frank has over 30 years of professional work experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies and in various departments during this time.

    After University end of 1985, Frank joined B. Braun Melsungen, AG Melsungen/Germany as Design Engineer. In 1987, he already took over the In-process Control Department for Medical Products as Manager and in 1993 he was promoted to Head of the Quality Control Department, including incoming control for all raw materials and in-process control, final control, complaint handling, calibration and process and machine validation for all medical products. During that time, Frank was as well involved in the conversion from EN 46000 series to the new ISO 13485/13488 series and was part of the implementation team for the Medical plant in B. Braun’s Head Quarter in Germany.

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