Navigation Links
French Regulator Lina Ertle, FDA's Jeffrey Baker and Patrick Swann Confirmed Speakers at 2013 PDA/FDA Process Validation Workshop
Date:3/7/2013

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

(Logo: http://photos.prnewswire.com/prnh/20130226/DC66667LOGO)

"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.

About PDA:

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.

Media Inquiries: Walt Morris , 301-656-5900; morris@pda.org


'/>"/>
SOURCE Parenteral Drug Association
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. French Lifestyle Secret Finally Revealed: Lycotec Publishes Unexpected Findings on Roquefort Cheese
2. French Government Agrees to Fund Study of the PneumRx RePneu Lung Volume Reduction Coil
3. Pycnogenol® (French Maritime Pine Bark Extract) Shown To Improve Endothelial Function And Reduce Oxidative Stress In New Clinical Trial
4. PCMA Recruits Wendy Krasner as New Vice President of Regulatory Affairs
5. CPhI Announces its 2nd Annual Global Pharma Regulatory Summit
6. Emerging Pharmaceutical Market in South Africa - Proposed Introduction of New Drug Regulatory Agency (SAHPRA) to Accelerate Drug Registration Process
7. Marken Expands Regulatory And Technical Excellence In Logistics
8. Proposed Regulatory Uniformity to Boost Venture Capital Investments in Healthcare Arena, Says Frost & Sullivan
9. Hadasit Bio-Holdings Portfolio Companies Receive Funding to Support Clinical Trial Preparations and Obtain Regulatory Approvals in U.S. and Europe
10. Global Healthcare, Regulatory and Reimbursement Landscape Forecasts and Trends in UAE, Canada and Taiwan
11. Memorandum of Agreement: Training State Regulators to Advance the Quality of Orthopaedic Care for China
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/16/2017)... , June 16, 2017  Exactly 50 years ago ... off what later became known as the San Francisco "Summer ... ) is unveiling two radical innovations in strategic market research ... This announcement marks the beginning of Northern Light,s "Summer of ... ...
(Date:6/12/2017)... , June 12, 2017 Kineta, Inc., a biotechnology ... Kineta Vice President of R&D and Head of ... Pandemic Preparedness for the Northwest and Beyond meeting ... on June 14, 2017 from 8:30-10:30 AM PDT at the ... Dr. Bedard will be joined by other ...
(Date:6/8/2017)... MAITLAND, Fla. , June 8, 2017  Less ... ransomware attack that hit more than 200,000 companies, including hospital ... is being heralded as one of the largest online ... technology in the healthcare market, it is imperative that ... can protect their data from this — and many ...
Breaking Medicine Technology:
(Date:6/23/2017)... , ... June 23, 2017 , ... Everybody has their ... while others prefer to read it, and some people don't like it at all. ... Here's what they found: , Erotic literature can give readers a taste of their ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South Asia Leaders Selected ... from government, business and civil society in 11 countries across the Middle East and ... in a transformative exchange of knowledge and ideas with the leading minds in their ...
(Date:6/23/2017)... ... 23, 2017 , ... Ulster University, Magee Campus in Northern Ireland is hosting ... pm to present to graduate students exciting new and innovative hope research based on ... by The Health Improvement Service of the Western Health & Social Care Trust (WHSCT) ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore Insurance, ... area with access to asset protection and financial planning services, is teaming up ... improving the lives of children with cancer and other chronic diseases. , The ...
(Date:6/22/2017)... ... June 22, 2017 , ... ... from the American Heart Association (AHA) to launch a Rheumatic Heart Disease Center, ... prevention and diagnosis of rheumatic heart disease (RHD) in high-risk, financially disadvantaged countries ...
Breaking Medicine News(10 mins):