Annual cGMP Drug/Device Combination Products Training 21 CFR 820, ISO 13485:2016, CFR Part 4, 210 and 211)
Length of Course
0.5 Day
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
Level of Difficulty
Beginner (no knowledge at all of the topic).
Employees working in a drug/device combination product manufacturing environment must receive annual cGMP refresher training. This training courses is designed to designed to meet this need.
At the conclusion of this course, participants should be able to:
• Demonstrate a basic knowledge of drug/device product CGMP requirements
• Understand any regulatory updates to the drug and device CGMP regulations
• Understanding any industrial trends that could impact the CGMP requirements for combination product
Individuals work in a cGMP environment in a drug/device combination product manufacturing company.