Microbiological cGMP Requirements for the Non-Sterile and Aseptic Fill ‘n Finish Environment
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
As a product proceeds through manufacturing to the API with the addition of various excipients, both non-sterile and sterile products (aseptic fill ‘n finish) must be tested for their microbiological content. With non-sterile products, a limited number of microorganisms are acceptable; with sterile products, no microorganisms may be present. Often issues of OOT, OOS and CAPAs become critical at this juncture point. Quality Metrics and their Risk Based implications of deviation related issues will be considered for both non-sterile and aseptically produced products.
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 from the end of production through final release for both non-sterile and aseptic produced products. A review of Case Studies/Warning Letters pertinent to all phases of the microbiological release (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 a fill ‘n finish environment - Review non-sterile products and how USP<61>, <62>, and <1115> impact these products and the number of microorganisms and species permitted in final products - Review aseptically produced products and how the revised USP<1116> may impact any observed contamination within the Clean Room environment - Study how OOT, OOS and CAPAs impact all aspects of the microbiological environment - Review the use of metrics and risk management to assess problem solutions - Case studies to include Form FDA 483s and Warning Letters
Webinar outline and time breakdown:
|10:15 AM||Log In Period|
|Considerations of USP <61>, <62> and <1115>,|
|Issues with Non-Sterile Product in a Fill ‘n Finish Environment,|
|Number and Species of Microorganisms Permitted in Non-Sterile Products,|
|Issues with Sterile Products in a Fill ‘n Finish Environment,|
|Gaining an Understanding of USP Sterility Tests <71> and the Impact of a Positive Result,|
|A Review of the Revised USP <1116>||11:30 AM||Break|
|11:40 AM||Deviations, Out of Specifications and Out of Trend and Their Impact on The Final Product,|
|The Use of Metrics to Assess Problem Solutions,|
|Frequency of 21 CFR 211 Microbiological Observations Within Final Products|
|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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