Combination Drug/Device Products CGMPs - Final Rule 2015

Key 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