FDA Quality System Regulation 21 CFR Part 820 Training
Course Category: Medical Devices
Course Title: FDA Quality System Regulation 21 CFR Part 820 Training
An intensive two day training course on how to establish and improve compliance with the Quality System (QS) Regulation which contains the GMP requirements for medical devices. The FDA Quality System Regulation 21 CFR Part 820 was published on Monday October 7th, 1996, and came into effect on June 1st, 1997, while the Design Control requirements came into full effect on June 1st, 1998. FDA has stated that this major revision was necessary to improve medical device safety and effectiveness. In effect, it imposed significant new requirements on device manufacturers. In many cases manufacturers have not satisfactorily established compliance with the regulation and have received adverse FDA inspections, Warning Letters and Import Alerts.
Course Presenter
This course is presented with our training partner, Tom Donnelly of Medicom Consulting.
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
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.
Course Structure
This course is a 16 hour/2 day course.
Course Start: 09:00a.m & Course Finish: 17:00p.m
A detailed course breakdown is as follows:
- 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
Training Methodology
The course presents the Quality System Regulation comprehensively, it uses case studies, interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. This course can also be tailored to meet your specific requirements.
What's Included on the course
- Comprehensive Course Manual
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Training Certificate of Attendance
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 4491224 or email info@kelmacgroup.com
€1,095*/Person-
21 May 2012
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11 June 2012
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13 June 2012
