PDA Letter Article

Making The Most of External Signals for Internal Learning and Knowledge Management

by Denyse D. Baker, Eli Lilly and Company, Jackie Veivia-Panter, BioCentriq, and Janeen Skutnik-Wilkinson, Moderna, Inc.

Staying compliant with training regarding your quality system is imperative in the fast-paced business of delivering pharmaceutical medicines. Still, having the time and systems that enable learning is often challenging instead of just checking the boxes with a read-and-sign approach. On top of that, the pace of change is accelerating as new regulatory requirements and commitments require continuous evaluation and often lead to updates in standard operating procedures and processes, putting even more pressure on your training approaches. Moreover, to ensure your quality system is fit for purpose, it should be built upon a culture focused on quality assurance and continuous improvement that supports building capability and sharing knowledge across your workforce to enable them to make the right decisions to ensure product quality and patient safety.

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One key input to such a robust quality system is staying current and keeping your staff well informed on the latest health authority developments across all your markets. The industry has come a long way from reading the Code of Federal Regulations announcements daily and assuming that tracking the U.S. FDA publications is sufficient. Many companies now have full-time intelligence, external monitoring staff, or contracts for such services.

Suppose a company struggles to turn intelligence into internal value and translate information from trade/professional organizations and conferences into internal action. In that case, the 2023 PDA/FDA Joint Regulatory Conference in Washington, D.C, on September 18-20, will feature several sessions addressing the challenges in learning and monitoring the external environment and examples to improve knowledge sharing across your organization. Monday afternoon starts with a session on building an effective quality/cGMP intelligence program. Participants will learn about the importance of a strong intelligence team, what tools other companies are using and where there are opportunities for collaboration. This is followed by a session on Innovations in cGMP training, discussing what it will take to transform companies beyond basic compliance into learning organizations. Come and listen from your peers about best practices to build a culture of learning because training is foundational to a company's success and quality culture.

Some of the best reasons to attend the 2023 PDA/FDA Joint Regulatory Conference are to hear the regulatory perspectives and to have the opportunity to ask direct questions. This year’s conference will be no exception, with FDA members of the planning committee and FDA speakers and moderators in many sessions. Tuesday features the Center and Compliance Updates sessions, and Wednesday’s Lunch with the regulators is a chance to ask your follow-up questions. You cannot afford to miss this opportunity to upskill your staff and yourself. Early bird registration is open now through 23 July.

About the Author

Denyse BakerDenyse Baker is Associate Vice President of External Engagement and Advocacy for Global Quality Compliance with Eli Lilly and Company. With more than 30 years of experience in the industry, trade association and U.S. FDA roles, she is passionate about connecting and collaborating to promote the importance of science-based regulation and organizational quality culture as foundations for delivering high-quality products to patients. She is vice-chair of PDA’s Regulatory and Quality Advisory Board, co-leader of the Quality Maturity Task Force and has trained over 100 regulators on the PDA Quality Culture Assessment Tool. Denyse is a licensed professional engineer with RAC certifications in U.S. and EU regulatory affairs.

Jackie Veivia-PanterJackie Veivia-Panter is a Senior Quality Management professional with extensive experience in quality systems for the pharmaceutical and cell and gene therapy (ATMP) industries. Jackie's greatest assets are in identifying strengths and weaknesses of quality systems and building a team to design and deliver effective and compliant solutions, processes and organizational models. Also, Jackie's career includes managing site quality, research and development (R&D) quality and divisional roles, including training and matrix organization management. Finally, Jackie has diverse experience, from leading a global team at a large pharma company to leading site quality at a contractor serving many large and small pharmaceutical /biotech clients.

Janeen Skutnik-WilkinsonJaneen Skutnik-Wilkinson is the Director of Global Regulatory Surveillance and External Engagement at Moderna. In this role, she is responsible for building the regulatory surveillance and external engagement function within quality. She is responsible for ensuring that new and revised guidelines/regulations are reviewed and assessed for impact. She is also responsible for coordinating comments to trade associations and regulators based on draft guidance and regulations that pertain to quality.