2020 - Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

Upon completing this course participants should:
Understand the fundamentals of GMP for the United States
Understand how to determine what GMP-governed operations you are performing internally versus what you are outsourcing
Understand a method to structure your quality management system and decide which procedures you need now versus which ones can wait
Understand best practices for vendor management
Learn how to apply GMP concepts to Phase 1, 2 and 3 investigational drugs
Learn the differences between an FDA GMP inspection, a Pre-Approval Inspection and a Pre-License Inspection and where to obtain guidance for each
Understand basic principles of FDA inspection authority, what to expect if FDA inspects your virtual firm, and how to manage the presence of FDA personnel on site