Learning Objectives:

Participants in this seminar will:

• Understand the GMP and GCP requirements all virtual companies must meet regardless of the extent of their outsourcing operations
• Understand how to select, qualify and monitor CMOs, CROs and Contract Laboratories
• Learn the elements to include in a quality agreement (also known as a technical agreement)
• Learn how to determine which GMP or GCP requirements apply to you, depending on the things you do internally and those you outsource
• Understand your obligations under the law for products you release to the clinic or the marketplace
• Appreciate the importance of maintaining data integrity
• Learn how to effectively manage a health regulatory inspection:
  • Inspection logistics
  • Responding effectively to document requests and questions from inspectors
  • Managing the inspection exit discussion
  • How to write an effective response to inspection observations
  • How to find applicable inspection references and procedures of the FDA, EMA and Health Canada