Course Title: 21 CFR Part 820 Quality System Regulation and FDA CGMP Requirements for Medical Devices
SOCSO Course Category: Manufacturing
SOCSO Course Code: HIT3054
This course introduces the concepts needed to understand, develop, implement and run a quality system as outlined in the US FDA 21 CFR 820 Code of Federal Regulations. It provides understanding the legal requirements and regulatory expectations relating to cGMP Quality System Regulation (QSR), as well as the cost of non-compliance.
- Quality Management System (prerequisites and what to be considered)
- Quality System Regulation (guidance about Sub-Parts A to O)
- Resources and Links
- Implementation of Quality System Regulation
- Maintaining compliance to 21 CFR Part 820
- Quality System Inspection Technique (QSIT)
- The FDA Inspection Process / How to get ready for FDA Plant
Anyone involved in defining, planning, implementing or running a 21 CFR 820 compliance GMP Quality Management System, management representatives, implementation team members, management or Quality personnel working in the medical device industry. Quality Assurance Manager/personnel expecting and/or preparing for a FDA Inspection.
Knowledge about quality management system for Medical Device Industry (ISO 13485:2016) would be beneficial.
Two (2) full days