Validation of Microbiological Test Methods; PDA Technical Report No. 33, USP <1223> and AOAC International Qualitative and Quantitative Microbiology Guidelines for Method Validation
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
Validation of microbiological methods is gaining interest in today’s environment with the revision of PDA Technical Report No. 33, “Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods”, USP <1223> “Validation of Alternative Microbiological Methods”, and “AOAC INTERNATIONAL Qualitative and Quantitative Microbiology Guidelines for Methods Validation” as well as the continuing evolving of rapid microbiological methods. With the FDA most willing to participate in more rapid microbiological in-process and final product releases and the opportunity to obtain results in hours, rather than days, a litany of companies are developing their versions of rapid microbiological methods. The questions for each of us are what is most applicable to both our in-house and regulatory requirements and are they cost effective. To perform these analyses, we need to examine the DQ/IQ/OQ/PQ of these various instruments as well as microbiological method validation.
The objective of this live training webinar is to explore the validation of microbiological test methods and the efforts required (both monetary and manpower) to satisfactorily meet their validation requirements.
-Characteristics of traditional and contemporary methods. -New technologies for microbiological testing <62>. -Regulatory expectations. -Initial considerations required to meet the microbiological plan design. -Establishing analytical procedures based on process/product requirements. -Developing acceptance limits for products, components and processes. -Validation plan design. -Elements of a microbiological validation. -Review of validation criteria and recommendations for satisfying each as part of a microbiological validation.
Webinar outline and time breakdown:
|9:15 AM||Log In Period|
|New Technologies for Microbiological Evaluation,|
|Establishing New Microbiological Test Methods,|
|Validating a Microbiological Test Method - The Elements,|
|10:40 AM||Validating a Microbiological Test Method - The Elements (con't),|
|Performing a Microbiological Validation,|
|11:30 AM||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
- Regulatory Affairs Professionals
- Auditing Professionals
- Microbiology Professionals
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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