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

Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a product ready for market approval in the coming months.
Most such companies are small, and may not have deep expertise in QA and GMP compliance, relying on their partners to cover those areas. Companies who outsource the majority of operations through the use of Contract Manufacturing Organizations (CMOs),
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)
Speaker:
David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide.