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Parenteral Drug Association
Connecting People, Science and Regulation
®
Parenteral Drug Association
Connecting People, Science and Regulation
®
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Press Releases
12/10/2014
PDA Announces Board of Directors Election Results
The Parenteral Drug Association (PDA) announced today the results of its 2014 Board of Directors election. PDA members voted for four volunteer directors over a period of three months this past fall.
12/05/2014
PDA Pharmaceutical Quality Metrics Conference Offered Industry and U.S. FDA a Forum to Discuss Future Risk-Based Inspection Program
Washington, D.C. (December 4, 2014) – The Parenteral Drug Association (PDA) today closed its second annual Pharmaceutical Quality Metrics Conference with panels of distinguished representatives of pharmaceutical companies and officials from the U.S. FDA, the European Medicines Agency and the UK's regulatory body for medical products. Nearly all of the conferences 250 attendees remained engaged through the final panel discussions Thursday.
10/28/2014
PDA Publishes Pharma. Quality Metrics Definitions in Points to Consider Paper
Bethesda, Md., October 27, 2014 Year – The Parenteral Drug Association (PDA) published definitions for four key quality metrics in an updated version of its “Points to Consider: Pharmaceutical Quality Metrics,” which was first published independently in December 2013.
10/16/2014
PDA Offers Help in Applying Single Use Systems to Bio/Pharma Operations
Bethesda, Md., October 16, 2014 – The Parenteral Drug Association (PDA) announces the completion of guidance on the application of single-use, or disposable , systems in the manufacturing operations for pharmaceutical and biopharmaceutical products with the publication of Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.
09/22/2014
PDA Launches Effort to Harmonize Global Post-Approval Changes Protocols
Bethesda, Md., September 19, 2014 – The Parenteral Drug Association (PDA) is moving forward with an initiative to harmonize global post-approval changes protocols.
09/10/2014
PDA Announces Development of Technical Report on Prevention and Management of Drug Shortages
Washington, DC, September 9, 2014 – The Parenteral Drug Association (PDA) today announced its plans to publish a Technical Report on the prevention and management of drug shortages. Regulators in the United States and Europe have been reaching out to industry to find ways to mitigate the kinds of shortages driven by manufacturing disruptions resulting from quality problems and regulatory enforcement activities.
09/08/2014
PDA Opens Quality Culture Survey
Bethesda, Md., September 5, 2014 – The Parenteral Drug Association (PDA) today launched one of two surveys on Quality Culture Metrics as part of its continuing program to evaluate quality metrics that can inform the regulator’s risk-based inspection programs.
07/24/2014
PDA Training and Research Institute Adds 31 Courses to GSA Schedule
Bethesda, Md., July 24, 2014 – The Parenteral Drug Association (PDA) announced today that 31 of its Training and Research Institute (TRI) courses are now listed with the U.S. General Services Administration (GSA) under a Federal Supply Schedule contract.
07/17/2014
FDA Acting Chief Scientist Ostroff to Speak at the 2014 PDA/FDA Joint Regulatory Conference
Bethesda, Md., July, 16 2014 – The Parenteral Drug Association (PDA) has confirmed FDA’s Stephen Ostroff, M.D., Acting Chief Scientist in the Office of the Commissioner will present “FDA’s Views on Scientific Advances and their Impact on Manufacturing of the Future” on September 8, 2014 in at the opening plenary session of the 2014 PDA/FDA Joint Regulatory Conference in Washington, DC at the Renaissance Hotel.
06/18/2014
CDER Director Woodcock, 27 U.S. FDA Speakers Confirmed for 2014 PDA/FDA Joint Regulatory Conference
Bethesda, Md., June 18, 2014 – The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference.
05/06/2014
PDA Announces Participation of Four FDA Speakers for 2014 PDA/FDA Virus & TSE Safety Conference
Bethesda, Md., April 21, 2014 – The Parenteral Drug Association (PDA) announced today that it has confirmed the participation of four experts from the U.S. FDA in the upcoming 2014 PDA/FDA Virus and TSE Safety Conference, June 12-13, 2014, at the Hyatt Regency Hotel, Bethesda, Maryland.
04/29/2014
Four U.S. FDA Supply Chain Experts to Answer Industry Questions at PDA Conference
Bethesda, Md., April 21, 2014 – The Parenteral Drug Association (PDA) announced today that it has confirmed the participation of four experts from the U.S. FDA in the upcoming 2014 PDA/FDA Pharmaceutical Supply Chain Conference, June 3-4, 2014, at the JW Marriott in Washington, DC.
04/04/2014
Nominations Being Accepted for PDA Board of Directors
Bethesda, Md., April 4, 2014 – The Parenteral Drug Association (PDA) announced the opening of the nomination process for Board members for the 2015-2017 term.
02/19/2014
PDA Announces Opening Plenary Speakers for the 2014 Annual Meeting
Bethesda, Md., February 18, 2014 – The Parenteral Drug Association (PDA) is proud to announce that Dr. Mark B. McClellan, Director, Health Care Innovation and Value Initiative for the Brookings Institute and former FDA Commissioner and Dr. Rahul Singhvi, Chief Operating Officer, Vaccines, Takeda Pharmaceuticals International will be the Opening Plenary Speakers at the 2014 PDA Annual Meeting, April 7-9, JW Marriott San Antonio Hilly Country Resort & Spa in San Antonio, Texas.
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