Regulatory Aspects of Microbiology in a Non-Sterile Environment; A Review of the FDA Expectations & USP Non-Sterile Chapters

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

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product. This two hour webinar discusses various regulations and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Products that are sold as sterile, but include a non-sterile phase within their manufacturing cycle will also be reviewed since the Regulators often have concerns regarding these in-process materials. Thoughts about in-house microorganisms that may be considered as "specified" will also be discussed. Warning Letters, Recalls and USP Chapters will be used to highlight the various discussion points.

Learning Benefits:
-Review the various Regulations pertaining to non-sterile raw materials, in-process materials and final product.
-Examine the various USP documents that discuss the elements associated with the concept of non-sterile manufacturing.
-Gather information regarding the impact of process hold times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganism.
-Learn when recovered microorganisms require testing.
-Understand why Warning Letters and Recalls were issued for non-sterility .

Webinar outline and time breakdown:

Time*
9:15 AM Log In Period
9:30 AM Introduction
9:40 AM Definitions,
Review of the Regulations,
A Review of the Non-sterile Documents Associated with USP,
The Impact of Various Hold Times upon the Overall Process,
10:30 AM Break
10:40 AM Requirements for the Testing of Collected Microorganisms,
Which In-coming Materials, In-process Materials and Final Products Require Testing,
Learn about Sterile Products that Possess a Non-sterile Manufacturing Phase,
Learn about Warning Letters and Recall Regulatory Rationale,
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

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>>>

 

 

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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