The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding as well as a “refresher” of what requirements exist for the microbiologist throughout the production environment from in-coming through final release. A review of Case Studies/Warning Letters pertinent to all phases of the microbiologist’s environment will be reviewed to enhance the learning benefits. Please plan to attend this with an interdisciplinary team to share this information.
Webinar Takeaway
- To Gain an overall review of cGMP and those sections of 21 CFR 211 that impact microbiology within the Manufacturing environment
- Review USP, 21 CFR 211, EP, Canadian, ISO and various FDA Guidances that impact microbiological issues throughout the cGMP environment for the microbiologist within manufacturing/QC operations
- Determine how to control numbers/species of microorganisms within the manufacturing environment with disinfectants and antiseptics USP<1072>
- Review how to control water systems (PW/WFI) within a manufacturing environment
- Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment
- Review various Case Studies that involve Form FDA 483s and Warning Letters
Speakers
Dr Barry A. Friedman, Ph.D,
Consultant ,
Cambrex Bio SciencesDr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.
Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international.
Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.
Who Should Attend
- Quality Assurance
- Regulatory Compliance
- Quality Control
- Facilities
- Manufacturing
- Validation
- In-Coming Materials
- Project Managers
