Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Upon completion of this course, you will:

• Be conversant in the specialized language of laboratory compliance
• Be very familiar with the cGMPs and other regulations as they impact QC labs
• Know the current compliance "hot spots" that FDA and other regulatory authorities look for when inspecting QC labs
• Understand how to effectively deal with laboratory deviations and OOS results
• Have an understanding the what, how and why of laboratory equipment qualification and methods validation
• Understand how to properly prepare your QC lab for audits and inspections

Who Should Attend

This two-day course is designed for all persons who work in, supervise, or are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will also provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laboratory investigations and Corrective and Preventive Actions.

Steven A. Ostrove, Ph.D.

Steven A. Ostrove, Ph.D.

Specialties: Regulatory, R&D

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.