Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast and Lunch Included)

This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.

Each section of 21 CFR 211 (Current Good Manufacturing Practices [CGMP] for Finished Pharmaceuticals) will be covered interspersed with references from 21 CFR 600/610 (Biological Products: General) and 21 CFR 820 (Quality Systems Regulations). Although CGMP refers to 21 CFR 210/211 the other Parts (600 and 820) rely on Part 211 as well. In addition to the above, ICH, EU, and other comparisons will be made in order to provide a complete understanding of the regulations.

The GMP course provides a complete overview of the industry requirements as specified by the FDA.

Who Should Attend

This three-day Good Manufacturing Practices training is designed for those who work in a cGMP environment, from beginners to advanced professionals. It is designed for those whose roles and responsibilities require that they understand and apply cGMP quality principles to their job as related to product discovery, development, and/or manufacturing. It will benefit professionals who are new to industry by presenting an overview of the important concepts in a logical and natural sequence so they can begin to understand GMP regulations and begin applying them effectively. The GMP course is also designed to help both the "cGMP Intermediate" and the "cGMP Professional" by providing continuity from product development through facility construction and final product release. Understanding the ‘why' of cGMP principles along with valuable insights and examples that will assist them in their quality decision-making, as well as, demonstrating ways to make their present systems more effective.

This course is also useful for quality assurance and quality control managers, regulatory affairs professionals, auditors, training and production managers, and management interested in effective GMP compliance tools and techniques.

As this course addresses cGMP regulations, attendees working with finished pharmaceuticals, combination products, biological, APIs or devices will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.

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.

Other Courses:

• Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
• Process Validation for Drugs and Biologics

Publications:

Dr. Ostrove wrote a book in June 2016 titled, “How to Validate a Pharmaceutical Process, 1st Edition.” He has also published several book chapters, reference pieces and feature articles in a number of noted industry publications.

How to Validate a Pharmaceutical Process

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