USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>
Available Live On-Demand
USP recently released a new document describing bioburden control of non-sterile drug substances and products -- a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP <1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as nonsterile manufacturers have repeatedly asked the question "what degree of microbial cleanliness should I require with my nonsterile drug substances and products" and "how many microorganisms of a single genus may I have where USP<1111> has limits of either 100 or 1000 per gram"? Efforts have been made to historically determine these questions within other USP Chapters to include USP<61>, USP<1111> and USP<1231> which have addressed both test methodologies and microbial counts allowed. 21 CFR 211 has also "weighed into" this fray with their various regulations, but have not offered solutions. Quite often during lectures and seminars, the comment is overheard "With sterile products, it was so much simpler to provide a microbial answer because I have definitive endpoints".
This new USP General Information Chapter approaches nonsterile drug substance and bioburden control from a Risk Management perspective (ICH Q9). It compares considerations of excessive cost and complexity vs. added value to the consumer and the product. The document also provides microbial control considerations in an array of microbiological control areas to include manufacturing, equipment design, personnel and the overall management of a nonsterile microbiological control program.
The objective of this live, PharmaWebinar is to review this new document and consider how a risk-based approach to the control of potential contamination in nonsterile product manufacturing may assist your organization. Plan to bring a multi-functional group to this webinar to gain the most from this new USP General Information Chapter.
-Overall Management of a Microbiological Control Program.
-Microbial Assessment of Nonsterile Product Manufacturing Environments.
-Microbial Control Considerations During Product Development.
-Microbial Control Considerations During Manufacturing.
-Microbial Control of Drug Substance Manufacturing.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|Overall Management of a Microbiological Control Program,|
|Microbial Assessment of Nonsterile Product Manufacturing Environments,|
|Microbial Control Considerations During Product Development,|
|11:40 AM||Examine the Bases for the Bacterial Endotoxin Tests,|
|Microbial Control Considerations During Manufacturing,|
|Microbial Control of Drug Substance Manufacturing,|
|Warning Letter Examples,|
|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
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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