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

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, qualifying and monitoring your contractors to ensure they are meeting your requirements; and how to build a quality system framework that is not excessive for your current needs, but has the structure and integration to "grow with you" as the scope your operations change in the coming months and years.

Topics: GMP compliance for virtual companies, contract manufacturing organizations (CMOs), contract research organizations (CROs), Contract Laboratories, quality agreement, technical agreement, good clinical practice (GCP), FDA inspection for virtual companies