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Good Manufacturing Practices (cGMP)

 
  December 02, 2015  
     
 
Center for Professional Innovation & Education, Inc., Los Angeles, CA
Feb. 29 – Mar.2, 2016


This course covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States.  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 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 course provides a complete overview of the industry requirements as specified by the FDA.

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers:

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.

 
Deadline for Abstracts: n/a
 
Registration: CLICK HERE TO REGISTER
E-mail: info@cfpie.com
 
   
 
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