2020 - Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

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