PDA Letter Article

An Inside Look at the 2019 PDA Quality Week

by Eva Urban, CSL Behring, Susan Schniepp, Regulatory Compliance Associates, Lori Richter, ValSource, and Ghada Haddad, Merck


Are you ready to implement the quality risk management (QRM) requirements included in the soon-to-be released Annex 1 document? Are you aware that ICH is planning on revising ICH Q9: Quality Risk Management to provide guidance on the applications of QRM concepts? Whether you answer "yes" or "no" to these two questions, you should plan to attend the 2019 PDA Quality Week.

PDA is focusing on the complex subject of QRM for an entire week in December. The week is comprised of three unique, individual-but-contiguous miniconferences designed to educate attendees on all aspects of QRM. Participants can attend one, two or even all three. Each miniconference provides a different perspective on QRM. The first conference focuses on the emerging regulatory landscape, framing the requirements of the regulations that govern this important but elusive concept. The second event is a one-day workshop that encourages attendees to actively participate in defining successful risk management applications that can be translated to the workplace. The third related miniconference focuses on the challenges and opportunities an organization faces when developing a holistic QRM program.

PDA has secured thought leaders on QRM for all three events including Dr. Janet Woodcock, Dr. Greg Claycamp, from the U.S. FDA, David Churchward from MHRA, Guy Villax, CEO of Hovione, Dr. Anil Sawant, PDA board member and Senior Vice President, Global Quality Compliance, Merck & Co., Inc., Martin VanTrieste, Past PDA Chair and CEO of Civica Inc., Martin Nemec, PhD from Health Canada and Hal Baseman, Past PDA Chair and Chief Operations Officer, ValSource. In one session, attendees can communicate directly with members of the ICH Q9 working group to offer their perspectives for inclusion into the document's revision.

The 2019 PDA Quality Week promises to be one of the most comprehensive programs that addresses QRM. Do not miss this opportunity to collaborate with industry thought leaders and provide input on how QRM requirements should be implemented by our industry.

Learn more about the 2019 PDA Quality Week.