Title: Module 4 Conclusion
Course: PW-Course-Import-Test > Section: Module 4: Production and Process Controls

Module 4

In this module we learned about Production and Process Controls and why they are important when manufacturing medical devices. We learned about the general description of PP&C controls in Subpart G, Acceptance Activities in Subpart H and Non-Conforming Product in Subpart I.

There are no take away notes for PP&C.

Coming Up...

In the next Module we will learn about 21 CFR 820.100 Subpart J - Corrective and Preventive Action (CAPA). CAPA is a critical element of any medical device Quality System and is almost universally reviewed at some point during third party (e.g. FDA) inspections. The intent of CAPA is to detect and correct issues that can lead to product or Quality System non-compliances. CAPA is a “self-correction” mechanism that when used properly can help medical device manufacturers stay compliant with the regulations.