The USP <1113> Microbial Characterization, Identification, and Strain Typing. What it Means to cGMP; Exploring Various Available Methodologies to Characterize and Identify Microorganisms

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

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The identification of microorganisms is a key element in defining the root cause of a sterility test failure or determining the source of any on-going microbiological investigation. A variety of Guidances, Regulations and Testing Standards recognize the importance of obtaining the microorganism's identity. FDA's Guidance for Industry on Aseptic Processing speaks to the criticality of using genotypic microbial identification methods, 21 CFR §211.113 speaks to the issue of microbiological contamination control, USP General Chapters <62> and <71> discuss identification of microorganisms and the allowance for the invalidation of the sterility test, respectively. USP General Information Chapter <1111> describes what constitutes a "specified" microorganism for non-sterile product.

Microbial identification is an important component of processes that exceed Alert or Action Levels, contain "specified" microorganisms, cause Out of Trend (OOT), create failures within Sterility Tests and contribute to other product failures.

The monographs for non-sterile products references this test, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing.

This live training webinar will examine a variety of the issues surrounding microbial characterization and identification to include 1) when is a Gram stain sufficient, 2) when is a Genus identification sufficient, and 3) when must a species or strain identification be obtained. This presentation will review both phenotypic and genotypic methods available and what is considered the "Gold Standard" of identification. It will discuss why the FDA believes an on-site microbiologist is an asset to an organization that is releasing both non-sterile and sterile product.

The objective of this live training webinar is to explore various methodologies that are available to characterize and identify microorganisms and assist in determining what may be the appropriate method(s) for use in your facilities based on your organizational requirements and the level of microbiological training and experience that exist within your organization.

Learning Benefits:
-How to develop an overall strategy for determining how extensive an identification may be required.
-When a pure culture is and is not required for analysis <62>.
-The consequences of attempting to isolated microorganisms with a contaminated culture.
-Easy information to obtain using Phenotypic Characteristics.
-What Bergey's Manual of Systematic Bacteriology uses for taxonomic classification.
-Advantages/disadvantages of using Phenotypic methods.
-Advantages/disadvantages of using Genotypic methods.
-Verification of microbial identification methods.
-Review Warning Letters related to microbial identification issues.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Developing an Overall Strategy,
Requirements for Microbial Analyses,
Requirements for Microbial Analyses,
11:30 AM Break
11:40 AM Phenotypic vs. Genotypic Analyses,
Warning Letters - Microbial Identification Issues,
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 participation for attendee training 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
  • Auditors

Schedule & Deliver this Live Training Webinar Privately to Your Group

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: 215

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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

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"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