Overview
Within a Manufacturing Environment, cGMP microbiological issues always arise that require addressing. Whether the facility is considered to be a Controlled or Classified environment, whether it is manufacturing non-sterile or aseptically filled product, the Microbiology Environment of the product is critical to assuring products leave the facility with the microbiology specifications in control. As the facility is examined in additional detail, the environment also must be considered. Both airborne viable and non-viable particulate considerations must be explored and controlled within all areas from ISO 5 to 8. The water systems, which include potable water, purified water, and water for injection, will also be explored regarding their specifications, maintenance, and compliance.
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
Who Will Benefit
- Quality Assurance
- Regulatory Compliance
- Quality Control
- Facilities
- Manufacturing
- Validation
- In-Coming Materials
- Project Managers
Faculty Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. 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.
1.5 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
