USP <1111> Microbiological Examination of Non-Sterile Products; Controlling Microbial Contamination in Pharmaceutical/Biotech Non-Sterile & Sterile Manufacturing and the New Regulatory Attitude

Live, Interactive Training Webinar

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

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Microbial contamination within the pharmaceutical/biotechnology environment is a continuing challenge to the industry. With regulations continuing to become more stringent, various regulatory agencies have gained more "teeth" within their enforcement arms. With more and more large proteinaceous molecules evolving within the market place, aseptic filling has assumed more prominence and more of a role that requires control.

Non-sterile manufacturing involves issues and challenges many times overlooked in aseptic operations. These include the handling and evaluating of non-sterile components, environments and products.

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 discusses various issues in non-sterile and aseptic manufacturing to include: 1) establishing analytical procedures and acceptance specifications, 2) setting of specifications, 3) process development, 4) preservation, 5) holding times, 6) cleaning, 7) sanitization, and 8) approaches to evaluating recovered organisms. It will address how one determines what a “specified” or “objectionable” microorganism is. It will also discuss methods for enumeration of these microorganisms and why microbiological examination of the in-coming materials and the manufacturing process are critical to eliminating potential recall issues regardless of the finished product's non-sterile or sterile claims.

This live training webinar is for pharmaceutical, cosmetic and other industries that produce product labeled as non-sterile and sterile. Those in both decision and non-decision making capacities will benefit from this presentation.

Learning Benefits:
-Discuss key issues with microbiological control in manufacturing non-sterile and sterile products.
-Identify the regulatory concerns in both non-sterile and aseptic manufacturing.
-Review of an established non-sterile microbiological control program.
-Review of an established sterile microbiological control program.
-Identify gaps within current regulatory and industry expectations.
-Examine the new regulatory “attitude” that is being taken with non-sterile product.
-Explore Form FDA 483s and Warning Letters that have recently been issued and their relationship to microbial contamination.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Discuss key issues with microbiological control in manufacturing non-sterile and sterile products,
Expand key issues to include: 1) establishing analytical procedures and acceptance specifications, 2) setting of specifications, 3) process development, 4)preservation, 5) holding times, 6) cleaning, 7) sanitization, and 8) approaches to evaluating recovered organisms,
11:30 AM Break
11:40 AM Identify the regulatory concerns in both non-sterile and aseptic manufacturing,
Microbiological Attributes of Non-Sterile Pharmaceutical Products,
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 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
  • Project Management
  • 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: 223

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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