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,
In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed operations you retain and which you outsource; what the current expectations and best industry practices are for selecting,
- 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)
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.