course description
This four-hour course will highlight the main points for medical device good manufacturing practices as defined in Title 21 of the Code of Federal Regulations, Part 820, and ISO 13485 Quality System Regulations for medical device manufacturers. Additionally, good documentation practices and Part 11 Compliance for electronic recordkeeping are highlighted to ensure participants understand that documentation is essential for regulated industry compliance. Participants will be exposed to deficiencies noted in warning letters and recall histories will be presented to demonstrate non-compliant behaviors and the consequences of these.
course specifics:
- Participant Cap - 30
- Delivery - Face-to-face or Virtual
- Course Length - Four (4) hours
- Printed Materials - Sent to company or college prior to delivery for them to print and disseminate