Compliance Media, Inc.

Intended Audience - Personnel who will be manufacturing and testing material for human use under U.S. and international GMPs. Suitable as an introduction or refresher course on basic GMPs for wet chemistry processes (drug and IVD) with a focus on clean operations. This class introduces and reinforces the requirements for manufacturing clinical and licensed materials intended for human use. Special attention is paid to clean and aseptic operations including discussion of cleanroom classes, LAF hoods and isolators. In addition to GMP requirements for documentation, product release, laboratory, and material controls, this class includes a discussion of validation levels appropriate for development and full scale GMP environments. Hand washing, gowning, area prep and behavior are demonstrated and assessed with tough plates to establish and reinforce behaviors necessary for manufacturing material suitable for clinical use. The importance of contemporaneous documentation and immediate reporting of problems for investigation are also stressed.