Topics
- The CGMP "Operating System"
- The Four Basic Types of Combination Products - physically combined, two or more of device, drug, biologic, packaged separately but intended for use only with another, different type of medical product ("cross-labeling") and packaged together
- Applicability of 21 CFR 210/211, 600-680, 820, and 1271
- Constituent Parts
- Single-type Constituent Part Facilities
- The Two Ways to Compliance
- How to Address CGMP "Conflict"
Who should Attend
Attendees from pharmaceutical, medical device, and biologics fields, including:
- Regulatory affairs
- Senior management
- Production
- Quality assurance
- All personnel involved in a U.S. FDA-regulated environment; especially those involved in CGMP compliance of affected regulated combination medical products
- Engineering
