Wednesday June 19, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
USP recently released a “General Information Chapter” 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 non-sterile manufacturers have repeatedly asked the question “what degree of microbial cleanliness should I require with my non-sterile 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 answer 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 relatively recent USP General Information Chapter approaches non-sterile drug substance and bioburden control from a Risk Management perspective (see 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, interactive Executive Conference Corp. (ECC) webinar is to review this recent document and consider how a risk-based approach to the control of potential contamination in non-sterile product manufacturing may assist your organization. Please plan to bring a multi-functional group to this webinar to gain the most from this recent USP General Information Chapter.
Learning Benefits of this Webinar Include:
-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.
Those Who May Benefit from this Webinar Include:
- Project Manager
- Manufacturing
- Quality Assurance
- Quality Control
- Validation
- Facilities
- Quality Auditors
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-605