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>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

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.

Learning Benefits:
-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:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Definitions,
New Technologies for Microbiological Evaluation,
Establishing New Microbiological Test Methods,
Validating a Microbiological Test Method - The Elements,
10:30 AM Break
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
  • Validation
  • 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>>>

 

 

Course Number: 224

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland