cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices

This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.

Topics included are:

• Impact of facility and equipment design on GMP compliance
• Risk management approach to compliance
• Vendors
• Commissioning, Qualification and Validation – Which one to use
• Problem resolution
• Part 11 in production and the laboratory

A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current "hot" topics and examples of recent warning letters will also be discussed and evaluated.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Steven A. Ostrove, Ph.D., has been involved in the Bio-Pharmaceutical business for over 35 years and is an invited course leader, lecturer and guest speaker for both national and international conferences.

In 1999, he opened Ostrove Associates, Inc. (OAI) – a validation, compliance and regulatory-affairs consulting company – to provide consulting services to both major pharmaceutical/biotechnology companies and small, start-up companies.

Previously, Dr. Ostrove worked as Senior Technical Specialist in the Technical Service Department of Pharmacia Biotechnology. He also served as Senior Director of Validation and Regulatory Affairs with a number of major design/build engineering companies.

In addition, Dr. Ostrove has also served as an adjunct professor of Pharmaceutical Engineering for Validation and Regulatory Affairs for the New Jersey Institute of Technology and as an adjunct professor of Biology for Kean College. He recently served as industry representative on an FDA advisory panel and as Acting Manager of Validation for a contract pharmaceutical/OTC manufacturer.