2015 PDA Quality Metrics Conference Offers Latest Details on FDA’s Metrics Gathering Program 4 November, 2015

Bethesda, Md., November 4, 2015 – The Parenteral Drug Association (PDA) is sponsoring its third conference on quality metrics Nov. 9-11 at the Bethesda North Marriott Hotel and Conference Center. The U.S. FDA is co-chairing the event. Agency representatives will use the forum to provide updates on its pharmaceutical quality metrics program that launched following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012.

"We find it very important to offer this forum on the quality metrics program so quality and other professionals within the pharmaceutical business can interact directly with FDA representatives," said PDA President Richard Johnson. "Just the very first session of the meeting has four presentation by FDA and concludes with an ample Q&A session with a panelist of five Agency officials."

Overall, seven FDA speakers will take the podium during the event. The British MHRA’s vision of quality metrics in Europe will be presented by Gerald Heddell, the Director of  the Inspection Enforcement & Standards Division. The rest of the agenda is dedicated to high-level presentations from industry representatives.

PDA has been an active contributor to the metrics program since FDA reached out for public input into the program. A PDA task force of industry experts has published two Points to Consider documents on quality metrics and a survey on quality culture. The team also helped plan the three workshops to date. In August, PDA’s Johnson spoke at a public forum on the just-released FDA draft guidance on metrics, and the task force is currently finalizing PDA’s official comments on the document.


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