French Regulator Lina Ertle, FDA’s Jeffrey Baker and Patrick Swann Confirmed Speakers at 2013 PDA/FDA Process Validation Workshop
BETHESDA, Md., March 7, 2013 /PRNewswire-USNewswire/ — The Parenteral Drug Association (PDA) announced today that three high-level regulators from the United States and Europe will speak at the 2013 PDA/FDA Process Validation Workshop, May 20 – 21 at the Hyatt Regency in Bethesda. They are:
- Jeffrey Baker, Deputy Director, Office of Biotechnology, CDER, FDA
- Lina Ertle, Quality Assessor, ANSM (France)
- Patrick Swann, Deputy Director, Division of Monoclonal Antibodies, CDER, FDA
“With global regulatory expectations for process control and validation changing in recent years, PDA’s members recognize the importance of engaging health authority representatives at a workshop like this,” said Richard Johnson, PDA President and CEO. “PDA has a long history of providing forums for manufacturers to exchange the latest thinking with their regulatory counterparts, and it is common for representatives of health authorities from different countries to appear at our meetings to open dialogue with industry experts.”
The workshop is intended to help industry learn about the U.S. and European regulatory perspectives on process validation. In recent years, regulators have expected manufacturers to take a life-cycle approach to process validation and utilize risk-management and statistical tools. Process validation experts from industry, representing companies like Pfizer, Baxter Healthcare, and Amgen, also will present.
More information on the workshop is available at http://www.pda.org/processval2013.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide.
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SOURCE Parenteral Drug Association