Microbiological cGMP Requirements for the Manufacturing Environment; From In-coming Through to Final Release
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
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 training 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.
- 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
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|Microbiology and the Controlled/Classified Manufacturing Environment,|
|Control of Numbers/Species of Microorganisms in the Non-Sterile Manufacturing Environment,|
|Airborne Viable/Non-Viable Particulates and the Manufacturing Environment,|
|Disinfectants and Antiseptics USP<1072> and Related Issues,|
|11:40 AM||Water Systems and Their Control Within the Manufacturing Environment,|
|Developing a Microbiological Sampling Plan Throughout the Batch Record,|
|Frequency of 21 CFR 211 Microbiological Observations,|
|Case Studies to Include Form FDA 483s and Warning Letters,|
|12:30 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Microbiology Personel
- Regulatory Affairs Professionals
- Project Managers/li>
- Those that use contract manufacturing and contract testing facilities
Instructor: Barry A. Friedman Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>
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