2023 PDA Microbial Data Deviation Investigations Workshop

13:30 – 15:15 | P1: Navigating Laboratory Investigations: Don't Get Lost in the Maze!
Moderator: Paula J. Peacos, MS, Senior Consultant, ValSource, Inc.

This session will delve into the unique aspects of a typical microbiological laboratory investigation. The presenters will be drawing on their combined 100 years of industry experience to provide practical and fascinating insights into the twists and turns that arise in conducting what would be expected to be a straightforward laboratory investigation. Both new and experienced laboratory investigators will discover useful insights and points to consider when conducting their own laboratory investigations.

15:45 – 17:15 | P2: What to do Without a CFU?
Moderator: Marc Glogovsky, MS, Business Unit Manager/Senior Consultant - Microbiology, ValSource, Inc.

With the recent “blessing” bestowed upon our industry from within the new EU/PICS Annex 1 guideline, there is a resurgence in the desire to select and implement a rapid microbiological method (RMM). The presentations and case studies in this session will guide the participants through different method utilizations as well as deciphering the data that may not conform to traditional methods (CFU). Attendees will have an opportunity to work through a laboratory-based investigation, while taking advantage of microbiological tools that provide contamination feedback in as little as a few hours.

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.