2019 PDA Quality Week - Quality Risk Management: The Inside Look
PDA is focusing on the complex subject of Quality Risk Management (QRM) during 2019 PDA Quality Week being held December 9-13, 2019 in Washington, DC. Are you ready to implement the QRM requirements that are included in the soon-to-be-released EudraLex Annex 1 Document? Are you aware that the International Conference in Harmonization is planning on revising ICH Q9 to provide guidance on the applications of QRM concepts?
If your answer is no, you should plan on attending PDA’s Quality Week. If your answer is I’m not sure, you should plan on attending PDA’s Quality Week. And yes, if your answer is yes, you should still plan on attending PDA’s Quality Week.
The Week is comprised of three unique, individual but contiguous events designed to educate conference attendees on all aspects of QRM. This new approach to conference and workshop offerings is designed so that participants can attend one, two, or all three, depending on their specific needs. Each offering provides a different perspective on QRM, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept from industry and regulators’ perspectives.
The second offering is a Workshop encouraging attendees to actively participate in defining successful risk management applications that can be translated to the workplace. The third related event focuses on the challenges and opportunities an organization faces when designing and implementing a holistic QRM program.
PDA has secured thought leaders on QRM for all three conferences, including:
- From the U.S. FDA: Dr. Janet Woodcock, Dr. Gregg Claycamp, Melissa Burns, and Lucinda Buhse
- David Churchward, MHRA, UK
- Guy Villax, CEO, Hovione
- Dr. Anil Sawant, PDA Board Member and Senior Vice President, Global Quality Compliance, Merck & Co., Inc.
- Martin VanTrieste, Immediate Past Chair, Board of Directors, PDA, and CEO of Civica Inc.
- Martin Nemec, Health Canada
- Anne Greene, Professor, Lecturer, and Pharmaceutical Project Manager, TU Dublin, School of Chemical and Pharmaceutical Sciences
- Hal Baseman, Past Chairman, Board of Directors, PDA, and Chief Operating Officer, ValSource, LLC
In one session, attendees will have the opportunity to dialog with members of the ICH Q9 Working Group to offer industry perspective and considerations for inclusion into this document’s revision.
PDA’s Quality Week promises to be one today’s most comprehensive programs addressing QRM. Don’t miss this unique opportunity to dialogue with industry thought leaders and provide input on how QRM requirements should be addressed and implemented by our industry.