In this episode of "The Top Line", sponsored by the Parenteral Drug Association (PDA), we do a deep dive into the highly anticipated PDA/FDA Joint Regulatory Conference, set to take place from September 9-11 in Washington D.C.
For this discussion, we’re joined by Janeen Skutnik-Wilkinson, Director of Global Quality Regulatory Surveillance and External Engagement for Moderna, and Co-Chair of this year's 33rd annual event.
Janeen says the direct access to federal regulators as a standout feature of this must-attend conference. With a high number of FDA colleagues in attendance, participants are provided with incredible networking opportunities, as well as a unique perspective on the current priorities and challenges faced by the FDA.
This annual FDA co-sponsored pharmaceutical CGMP conference is renowned for fostering collaboration among scientific minds to devise actionable, practical solutions and best practices. This year’s agenda emphasizes how to improve quality culture within organizations.
With a focus on shifting from reactive to proactive approaches and evolving quality maturity, Janeen explains that attendees will learn how to identify quality issues before they escalate with an emphasis on preventative measures.
Additionally, key sessions will include de-risking quality control environments and utilize case studies on Out of Specification (OOS) and Out of Trend (OOT) results to enhance laboratory systems using Quality Risk Management (QRM). The conference is uniquely focused on Current Good Manufacturing Practices (CGMP), making it essential for those in quality assurance and operations.
Janeen adds that practical advice will be a major focus area of all sessions, and affirms that the conference will delve into the role of AI in manufacturing and data integrity, emphasizing the need for careful implementation and foresight.
For a comprehensive look at this year's PDA/FDA Joint Regulatory Conference, listen to the full episode and register at pda.org/PDAFDA2024.