FDA QS Regulation 21 CFR Part 820 Workshop | IRCA
Course Overview Who is this course for?
An intensive two day FDA QSR 21 CFR Part 820 training course on how to establish and improve compliance with the Quality System (QS) Regulation which contains the GMP requirements for medical devices.
Course Basics What is essential to know?
- This is a 2-day (16hr) learning event.
- Start/Finish Times: 08:00am – 17:00pm (each day)
Course Learning TopicsWhat does the course cover?-
Course Overview
- Introductions and Administration
- FDA History, Organization and Foreign Inspection History
- The Quality System Regulation 21 CFR Part 820
- How to Prepare for and Manage an FDA Inspection
- After the Inspection
- Principles and practices of Process Validation
- Case Study 1: "The EVAP Process" briefing and break-out sessions
- Case Study 1: Group Presentations and Summary
- Quality System Inspection Technique (QSIT)
- Complaint Handling and Medical Device Reporting
- Case Study 2: "GMP Makes Business Sense" briefing and break-out sessions
- Case Study 2: Group Presentations and Summary
- Software Validation including requirements of 21 CFR Part 11, electronic records and signatures
- Q & A & Course evaluation
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*Kelmac Group cover this topic in more depth compared to our competitors.
**Kelmac Group proven added value as this material is not covered by the IRCA specification or our competitors.
Course Certification
This course is fully certified by Kelmac Group.
Learning Objectives - Obtain the most up-to-date information and interpretation on the Quality System Regulation, and how compliance with the regulation is determined by use of the Quality Systems Inspection Technique (QSIT).
- Improve confidence in preparing for, and hosting of an FDA inspection
- Gain fresh quality improvement strategies for your company.
Who Should Attend? - Quality Managers
- Quality Control Professionals
- Healthcare Consultants
- Medical Device Consultants
- Enforcement Officers
- Regulatory Personnel
- Certification Bodies/Registrars
- Professionals in the Medical Device Industry & Supply Chain
No review available.
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Available Nationwide
Tailored to you
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Fixed Fees, No Expenses*
Groups of 5+
*Exclusions, T&Cs apply
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