Microbiological Out of Spec and Out of Trend Results in Sterile and Non-Sterile Production
: 31 Jul 2019
Sector: Clinical, Pharmaceutical, Water
Type: Training, Webinar, Seminar
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 live interactive trianing webinar will explore the management of OOS practices, how to minimize deviations, OOT, OOS and CAPA and how to tackle these situations should they occur. Also determine how FDA and ICH regulations and guidances may impact them.
- Review of the new latitude within USP <61> and how it may impact OOT and OOS.
- Review issues that may occur within the Incoming Raw Materials, In-Process and API phases.
- How developing a comprehensive validation of the facilities, the aseptic processing area and gowning qualification can minimize non-conformances.
- How to manage when a failure still occurs.
- 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 Risk Management applies to deviations, OOS and CAPAs.
- Review Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
- Phase I and Phase II of an Out of Specification Investigation.
- Examine the new FDA “attitude” that is being taken with non-sterile product.
- Identify the OOT and OOS regulatory concerns in a cGMP environment.
- Review the microbiological issues that may occur within Incoming Raw Materials, In-Process and API phases.
- Discuss key issues in manufacturing non-sterile products.
- Identify gaps within current regulatory and industry expectations.
- Explore Form FDA 483s and Warning Letters that have recently been issued.