Dear colleague,
Our closing program will be a strong finish to an intensive exercise in bringing the industry up to date with conversations and guidance about the role of effective quality systems, compliance and FDA updates. Here’s what we’re looking forward to today: the popular lunch with the regulators, featuring Sandra A. Boyd, Drug National Expert, OMPTO, ORA, U.S. FDA, Alifiya H. Ghadiali, PhD, RAC, Lead Consumer Safety Officer, OCBQ, CBER, U.S. FDA, Brooke K. Higgins, MS, Branch Chief, OC, CDER, U.S. FDA, Laura S. Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, ONADE, CVM, U.S. FDA and Derek S. Smith, PhD, Deputy Director, OPMA, OPQ, CDER, U.S. FDA. These investigators, reviewers, and compliance officers will provide even more insights into inspection trends and center initiatives.
And don’t miss the closing plenary when Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. returns to the stage for a panoramic presentation on The Evolving Landscape of Pharmaceutical Manufacturing.
Mary E. Farbman, PhD, Associate Vice President, Global Quality Compliance, Merck & Co., Inc. will sit down with Dr. Marks for a fireside conversation to answer all your questions. Get ready to take some notes as this conversation will be full of important learnings.
ORA Becomes OII
Before we get to Tuesday’s recap, here’s more detail on the ORA reorganization. We hope you find this summary helpful for you and for your team when you return to the office.
As Michael Rogers covered on Monday, the Office of Regulatory Affairs (ORA), responsible for conducting field inspections of all FDA-regulated facilities, will be renamed the Office of Inspections and Investigations (OII). Current ORA compliance officers will report to the compliance functions within the centers for biologics, drugs, devices, food safety and veterinary medicine. The reorganization takes effect on 1 October 2024.
The new OII will focus on inspections, investigations and imports as its core mission. Another key aspect of the reorganization is the creation of the Office of Enterprise Transformation within the Office of the Commissioner to focus on key information technology transformation projects across the FDA.
Tuesday Takeaways
In Tuesday’s plenary session, there were more updates on CGMP compliance trends with presentations from Melissa J. Mendoza, JD, Director, OCBQ, CBER, U.S. FDA, Jill Furman, JD, Director, OC, CDER, U.S. FDA, Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, OSC, CVM, U.S. FDA, and Alonza E. Cruse, Director, OPQO, ORA, U.S. FDA. Ms. Furman shared case studies of inspections of non-compliant facilities with associated regulatory actions. Ms. Mendoza recommended that companies work with FDA and underscored the importance of being proactive and taking preventive actions. She also recommended to ask questions up front to fully understand the warning letter and go to conferences like the PDA/FDA Conference to become informed and connected.
Mr. Cruse shared an innovative training approach when one of his drug experts worked with companies to create video footage on processes that they turned into a TED talk series. They are looking to expand training in the inspector space to address global challenges.
Dr. Burnsteel raised the issue of the role of senior manager in compliance - “what is leadership doing to be a role model for employees?”
Major Themes: Communication and Collaboration
We’re sharing a shout out to Jane Zhang, MBA, Co-Founder & Co-CEO, ETCH Sourcing and Jason Kerr, MBS, MBA, Senior Manager, Global Quality, Regulatory Intelligence and External Engagement, Moderna for their two dynamic presentations on behavioral change and management strategies.
Each had an engaging overview on what it takes to manage a workforce to ensure a quality culture and sustainable procurement. The focus was on the human factor and Zhang was candid in sharing the challenge of separating good intentions from unintended consequences. She said that although we assume that everyone has good intentions, there can still be unintended consequences.
Communication and collaboration (often a recurring theme across many of the conference‘s sessions) are crucial. Having experience in the trenches accounts for credibility in change management and Zhang said, “We are all firefighters; we have the experience.” She also said professionals don’t communicate their successes enough. She said positive role modeling is so important. Everyone needs a boost inspired by examples of what we have done that you can apply to yourself.
Jason Kerr provided an insightful case study of how managing a crisis can go terribly wrong. With a detailed retrospective of United Flight 173, he detailed why its ultimate crash is a lesson in risk management and assessment. The aviation disaster was the result of the lack of communication and collaboration among the key players and their oversight in diagnosing the crisis in midair with catastrophic consequences.
They focused on responding the immediate issue and overlooked a strategic detail that put the flight into fatal peril. The issue, not surprisingly, was lack of coordinating teams to collaborate and communicate. He gave specific tips on managing risk in communications by using polite assertive communication, acting with integrity, being aware on nonverbal communication, and engendering offering trust and understanding.
Advisory Board Updates
PDA’s Advisory Boards are committed to supporting the advancement of pharmaceutical science and regulations so members can better serve patients. Two of the four PDA Advisory Boards, Regulatory Affairs and Quality Advisory Board (RAQAB) & Science Advisory Board (SAB) held great in-person and virtual meetings on Sunday, prior to the PDA/FDA Joint Regulatory Conference.
RAQAB reviewed ongoing activities, how to engage early career professionals (ECPs) and students, inspection trends, regulatory affairs, and the importance of knowledge management in the industry. The discussion highlighted the need for training, gap assessments, and improvements in knowledge management practices within PDA and the industry. SAB reviewed numerous ongoing activities, future plans, and their achievements. The discussion focused on the upcoming publication of Annex 1: One Year Later Survey, anticipated late 2024, and the Points to Consider on Restricted Access Barrier Systems, anticipated early 2025.
PDA’s Advisory Boards guide and support the development of Technical Reports, Standards, Points for Consideration documents, PDA Research, and PDA Journal and PDA Letter articles. Two recently published PDA Technical Reports are now available at the PDA bookstore! Get your copy of PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users and PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages (free download to the public) today!
Also, PDA is now making its Technical Report Live (TRL) Sessions available to attend live or watch via recording. Check out the recently recorded TR 48 TRL, registration is free>
Explore more information on the topic on the PDAFDA Conference Onsite Attendee Webpage>
What’s New at PDA
Feeling the halls today are a bit empty now that our highly relevant supporters and exhibitors have moved out? Take a few moments to explore offerings from PDA along the PDA blue posters. Learn about PDA’s new book publications that are bound to become the newest meaningful references across the industry.
Also, learn more about Advanced Therapy Medicinal Products (ATMP) Interest Group using LinkedIn to collaborate and share.
In Closing
Have any learnings to share with us? Please respond to this email and we will be happy to share your thoughts on our on-site webpage.
Watch your email later today for the PDA/FDA Joint Regulatory Conference attendee survey. Please take a few minutes to share your thoughts with us.
Don’t forget to visit the online attendee webpage for featured content, videos and photos from the conference … and so much more. The on-site webpage remains available to you to further explore after the conference.
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With my greatest thanks to you and all attendees who made the 33rd annual conference meaningful, fulfilling and an immersive learning experience.
Sincerely,
Milind Ganjawala, MS, MBA, Co-Chair, PDA/FDA Joint Regulatory Conference and U.S. FDA Division Director, DDQ2, OMQ, OC, CDER
