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 '/>"/>

SOURCE Parenteral Drug Association
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:8/27/2014)... NORWALK, Conn. , Aug. 27, 2014  UBM ... , a leading online community for medical imaging professionals, ... Association for Medical Imaging Management,s 2014 Annual Meeting ... the conference coverage: , 11 Principles ... management can lead to greater profitability. , ...
(Date:8/27/2014)... , Aug. 27, 2014 /PRNewswire-iReach/ -- Emergency ... design, blended emergency medical training and response technologies, ... defibrillator) training from the Department of Homeland ... Reserve 81 st Regional Support Command ... contract includes nationwide CPR/AED/First Aid training. The Army ...
(Date:8/27/2014)... , Aug. 27, 2014   Auxilium Pharmaceuticals , Inc. ... biopharmaceutical company, today announced that certain members of the ... Healthcare Conference to be held September 8-10, 2014 in ... , Chief Executive Officer and President, is scheduled to ... portfolio at 10:55 a.m. ET on Wednesday, September 10, ...
Breaking Medicine Technology:Diagnostic Imaging Covers Association for Medical Imaging Management (AHRA) 2014 Meeting 2Diagnostic Imaging Covers Association for Medical Imaging Management (AHRA) 2014 Meeting 3Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 2Emergency University Equips Homeland Security, Army Reserve with SCA Response Program to Save Lives of Sudden Cardiac Arrest Victims 3Auxilium Pharmaceuticals, Inc. To Present At The Morgan Stanley Healthcare Conference 2Auxilium Pharmaceuticals, Inc. To Present At The Morgan Stanley Healthcare Conference 3
... Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in ... it has dosed the first patient with recent onset ... ongoing Phase I study of QPI-1007, the Company,s proprietary ... The Phase I open-label, dose-escalation study was initiated ...
... PHILADELPHIA, Oct. 20 ERT (Nasdaq: ... for the third quarter 2010 on Thursday, November 4, 2010, ... host a conference call at 5:00 PM EDT that day. ... dial 1-800-860-2442 when calling within the United States or 1-412-858-4600 ...
Cached Medicine Technology:Quark Pharmaceuticals Doses First Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Patient in Stratum II of its Clinical Study of siRNA Drug Candidate QPI-1007 2Quark Pharmaceuticals Doses First Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) Patient in Stratum II of its Clinical Study of siRNA Drug Candidate QPI-1007 3ERT to Announce Third Quarter 2010 Results on November 4, 2010 2
(Date:8/27/2014)... Will Holbrook, CP LP, has joined ... over 15 years of experience in the prosthetics field. ... with a Bachelor of Science degree with a major ... received his graduate degree in prosthetics at Northwestern University ... Will join us at Fourroux,” says Keith Watson, owner ...
(Date:8/27/2014)... 27, 2014 (HealthDay News) -- A new genetic discovery ... fight the bowel disorder, researchers report. The ... affect how their genes work, and said these changes ... raising the possibility of a simple diagnostic test for ... disease develops and suggest possible gene targets for new ...
(Date:8/27/2014)... The American Brain Tumor Association is ... Research Fellowships and 2014-2015 Discovery Grant Awards. Through the ... the field with talented, bright young investigators who have ... effects, diagnosis and treatment of brain tumors. This year’s ... the potential to advance the understanding and treatment of ...
(Date:8/27/2014)... Albany, New York (PRWEB) August 27, 2014 ... published by Transparency Market Research "Ablation Technologies Market ... Technologies: Radiofrequency, Light/Laser, Electrical, Ultrasound, Microwave, Cryotherapy) - ... Forecast, 2014 - 2020," the global ablation technologies ... 2013 and is estimated to reach a market ...
(Date:8/27/2014)... Center for Leadership in Disability (CLD) has received ... Child Health Bureau of the Health Resources and ... Plan for Georgia, aimed at improving services for ... In preparing for this project, CLD worked with ... from across Georgia. The resulting plan addresses priorities ...
Breaking Medicine News(10 mins):Health News:Scientists Spot Genetic Clues to Crohn's Disease 2Health News:American Brain Tumor Association Awards New Research Grants to Best and Brightest Investigators 2Health News:American Brain Tumor Association Awards New Research Grants to Best and Brightest Investigators 3Health News:Global Ablation Technologies Market Expected to Reach USD 10.6 Billion in 2020: Transparency Market Research 2Health News:Global Ablation Technologies Market Expected to Reach USD 10.6 Billion in 2020: Transparency Market Research 3Health News:Global Ablation Technologies Market Expected to Reach USD 10.6 Billion in 2020: Transparency Market Research 4Health News:Global Ablation Technologies Market Expected to Reach USD 10.6 Billion in 2020: Transparency Market Research 5
... in the last one month in Deomali and its ... officer N Singh said today. // ,Singh ... war footing to bring the situation under control., ... claimed death of 20 people in 15 days and ...
... of Georgia say that even if the surgery has gone ... of cardiovascular disease// and possibly cancer for several weeks post-operatively. ... is that when bad things happen down the road, months, ... in the past, just attribute it to the natural course ...
... today said it has entered into an agreement with ... of Foot and Mouth Disease (FMD) vaccine developed by ... the agreement, we will produce and market the vaccine ... meet the requirements of the domestic market and if ...
... 6. Even as asthma patients from different parts of ... fish medicine, rationalists have stepped up their campaign against ... of rationalists, has again urged the Andhra Pradesh government ... 'drug' was based on 'superstition'. ,The Bathini family, ...
... activity of a protein called NFATc1 tends to cause ... treat osteoporosis //- HHMI investigator Gerald Crabtree and HHMI ... bone is constantly being formed and being broken down ... cells called osteoblasts replenish it. ,‘Ideally, ...
... illness, which was under-diagnosed till now was found to ... thought before//. Intermittent Explosive Disorder or Rage disorder is ... outbursts. This illness if left untreated may also lead ... ,Intermittent Explosive Disorder attacks are out of proportion to ...
Cached Medicine News:Health News:Well-Planned Surgeries Also Carry Health Risks 2Health News:Well-Planned Surgeries Also Carry Health Risks 3Health News:'Fishy' Medicine Stirs Controversy 2Health News:'Fishy' Medicine Stirs Controversy 3Health News:Osteoporosis – A New Treatmen 2Health News:Osteoporosis – A New Treatmen 3Health News:Intermittent Explosive Disorder is More Prevalent Now Than Before 2Health News:Intermittent Explosive Disorder is More Prevalent Now Than Before 3
... CVA for CELL-DYN are assayed linearity control ... and to verify patient reportable range of ... also measure the linear performance of the ... have customized ranges appropriate for each instrument ...
The technology in the LATITUDE system allows your doctor to get the same data from your device whether you are at home or in your doctor's office. This information transfer happens automatically....
... Proprietary EX.P.R.T. Release ... jumping,, No stent shortening,, Unique anatomically ... in the carotid bifurcation,, 0.014 Rapid ... crossing profile and flexible atraumatic tip,, ...
... Para 5X is a whole blood ... Pentra 60C+, 80 and 120, and the ... product offers a unique white cell differential, ... the algorithms on the systems. The product ...
Medicine Products: