Wednesday May 15, 2019
12:00 pm – 1:30 pm EDT
Instructor: Barry A. Friedman, Ph.D.
Microbiological Out of Specifications may occur with the production of both non-sterile and sterile products. They may occur as early in the process as with In-coming Raw Materials and extend throughout In-process and Active Pharmaceutical Ingredient (API) phases to the final product.
With the advent of the revised USP<61> Microbial Examination of Nonsterile Products: Microbial Enumeration Test, a new latitude in result interpretation has come to the fore; however, one needs to understand how to utilize these inherent variations of USP<61> with Out of Trend (OOT) and Out Of Specification (OOS)
Microbial data deviations or non-conformances periodically may occur as well as OOT, OOS and Corrective and Preventive Actions (CAPA). However, unlike chemical analytical deviations, all microbial non-conformances to include OOS and CAPA investigations may require as many as six months to complete these studies based on their degree of difficulty and additional laboratory testing that may be required.
Sterility testing practices (USP<71> Sterility Tests) comprise the historical “gold standard” for releasing pharmaceutical and biotechnology products as sterile. Because extensive contamination is often required before a sterility test fails, regulatory agencies require initial and then periodic media fills as well as smoke studies, observation of technicians, and extensive environmental studies to add additional confirmation to sterility assurance prior to the commencement of aseptic filling. Therefore, OOS may not only directly examine sterility, but all of the results that indirectly impact it.
The objective of this live, interactive Executive Conference Corp. training webinar is to explore the management of microbiological OOS practices and suggested avenues to utilize to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. The webinar is also designed to determine how FDA and ICH regulations and guidances may impact these various practices. Please plan to bring an interdisciplinary group to attend this webinar to gain the most overall.
Learning Benefits will Include:
- Review of the new breadth within USP<61> and how it may impact both OOS and OOT.
- Review the microbiological issues that may occur within In-coming Raw Materials, In-Process and API phases of manufacturing.
- Learn how developing a comprehensive validation of the facilities, the aseptic processing area and gowning qualification can minimize non-conformances.
- How and when to bridge the “gap” between deviations, OOS and CAPAs.
- How the use of metrics may provide a “roadmap” for corrective action.
- Where Quality Risk Management (ICH Q9) applies to deviations, OOS and CAPAs.
- Review Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Examine the new FDA “attitude” that is being taken with non-sterile product.
- Identify the OOT and OOS regulatory concerns in a cGMP environment.
- Explore Form FDA 483s and Warning Letters that have recently been issued.
Those who should attend include:
- Manufacturing
- Validation
- Quality Control
- Quality Assurance
- Microbiology
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-108