iSpeak Blog

Oh No, the FDA Is Here! - Participate in Interactive Regulatory Panel

Matthew P. VonEsch
Oh No, the FDA Is Here! - Participate in Interactive Regulatory Panel

If you work in the parenteral manufacturing space, it’s a foregone conclusion that you can pinpoint the emotion and anxiety that comes from receiving word that the FDA has arrived at your facility for an inspection. If Billy Joel were to pen the lyrics it would begin “It’s nine o’clock on a Monday, a chemist, microbiologist, and trainee shuffle in. They say can we please see the head of quality, we’re not really sure of their name, but we’d like a tour and some time for questions; as the smiles run away from our face.” There’s adrenaline paired with concern and the silence of the hallways becomes deafening with the underlying question of “are we are prepared for this as we can be?”. Whether you are a seasoned pro or as green as the grass outside you are immediately reminded of the seriousness of our industry and products we release. At any given minute a patient is being dosed with a sterile product that we have produced with the objective being help and never harm. We sit in meetings discussing risk assessments and risk mitigation; inevitably the topic of desiring to have direct FDA feedback on our decisions/directions is brought up but wrongfully dismissed as an impossibility. While true the FDA serves as a regulator with their core focus being patient safety; they are also humans serving capacities within an ever-changing pharmaceutical landscape; like us they too have questions and are open to dialogue.

Reflect on this:

  • Have you ever pondered (not feared) having two days of near constant contact and connection with FDA thought leaders, outside the confines of your facility?
  • Imagine the opportunity to sit directly across from members of the FDA listening to their stories, their experiences (both good and bad), having the opportunity to ask questions about facilities, operations, regulations, impressions, etc.

For a multitude of reasons (annually held for 29 years, proximity to FDA headquarters, local and engaged focus on parenteral products), the ISPE Aseptic Conference offers this distinct opportunity. From the opening plenary session to the closing panel discussion FDA thought leaders are in constant circulation, whether it be participating in educational sessions, case-studies, or joining you for lunch.

What would you ask and how will you follow-up? At the 2020 ISPE Aseptic Conference , 2- 3 March in North Bethesda, Maryland you will have this exact opportunity. The FDA Regulatory Panel serves as a unique pinnacle of the conference where representatives answer audience-initiated questions from their respective department’s perspective, this year’s panel has over 120 years of FDA experience. Attendees can submit questions to the regulators in advance via an anonymous poll or for those brave enough there will be an open microphone.

Panel participants will include:

Alonza Cruse
Director, Office of Pharmaceutical Quality Operations
Rick Friedman
Deputy Director, Office of Manufacturing Quality
Christine A. Harman, PhD
Chemist, Review Branch 1
Jie He
Facility Inspection and CMC Review Branch 2
Brooke Higgins
Senior Policy Advisor for the Global Compliance Branch 3
Zhihao Qiu, PhD
Director (Acting), Office of Pharmaceutical Manufacturing Assessment
Robert Sausville
Director, Division of Case Management

If you or your team have a question about aseptic facility design for cell therapy products; environmental monitoring opportunities, FDA reflections on Annex 1 revisions, acceptability/risks associated with traditional cleanrooms/RABS/Isolators, isolator/RABS glove integrity testing, single-use aseptic connectors, negative vs. positive pressure isolators, pre-use post-sterilization integrity testing, observations from FDA around particulate introduction as a result of disposable technologies. Attendees are encouraged to participate in this event which could help prepare their organization for potential inspection observations before their fall into the category of a statistic. This open and direct interaction blends both humor and frank reflection from those that help guide inspections for our industry.

If you have a pressing quality or regulatory question for the respected FDA thought leaders in the aseptic processing space, we encourage you to join us at the conference and take full advantage of all that the conference offers. Sit through case-studies, technology sessions, and learn from those that have come before. This is your opportunity, why wait for the FDA to be in your building to ask these questions, when you can openly discuss them at this open forum. We look forward to welcoming you to the FDA Regulatory Panel on Tuesday 3 March from 1515 – 1700 EDT.