2023 PDA Microbial Data Deviation Investigations Workshop

08:00 – 09:30 | P3: Facilities and Utilities: Smarter Design, Reduced Risk
Moderator: Elizabeth Brockson, MPH, VPH, Aseptic Processing and Sterility Assurance Lead, Takeda

Has your facility ever suffered from unplanned down time? Do you really understand what goes on above the ceiling and behind the walls of your cleanrooms? Attendees of this session will learn how to de-risk microbial excursion potential based on smart facility and utility design, and what to do for legacy facility designs.

10:00 – 11:30 | P4: Navigating the Realm of Non-Sterile Drug Product Investigations
Moderator: Vanessa Vasadi Figueroa, MA, Executive Director, Microbiology, Quality Executive Partners, Inc.

Principles for investigating non-sterile drug products should generally follow the same rules as other types of microbial investigations, as the goal for finding the source of contamination remains the same. This segment will teach a variety of tools for determining the potential sources of contamination when assessing objectionable organisms found in non-sterile drug products, and for understanding the current FDA guidance on properly executing microbial data deviations. A case study will also provide background on a black mold isolated from an ISO 8 manufacturing area, and then guide attendees through an effective root cause analysis exercise for identifying its source.

12:30 – 14:00 | P5: Most Probable at Best: Investigating Sterile Product Microbial Data Deviations
Moderator: Kim Sobien, MBA, Senior Consultant - Microbiology, ValSource, Inc.

Investigating microbial data deviations for sterile products can be an arduous task that requires a trained eye and a deep curiosity for solving puzzles. Our presenters will take us through three adventures in aseptic manufacturing issues where knowledge and skill led to unraveling the mystery of microbial contamination. This session will help you learn how to search for root cause in all the right places and resolve sterile product microbial mishaps.

14:30 – 16:00 | P6: Panel Discussion and Wrap Up
Moderator: Christopher A. Murdock, PhD, CQA, Senior Director, Global Quality Systems, Bristol Myers Squibb

We will wrap up our Workshop with a panel discussion, including one presenter from each of our plenaries. Attendees will have the opportunity to ask any remaining questions regarding the importance of performing thorough microbiological investigations. A thorough investigations offers us the opportunity to identify problems, the root cause and implement meaningful CAPA to mitigate potential repeat events, thus improving our processes and even more importantly ensuring timely supply of necessary medicines to our patients. We hope you can bring back what was learned throughout the Workshop and implement it with your organizations.