Press Releases
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PDA Presents its Perspective on the US FDA Quality Metrics Draft Guidance at Public Meeting
Bethesda, Md., August 24, 2015 – The Parenteral Drug Association (PDA) today presented its perspective on the U.S. FDA’s draft Request for Quality Metrics Guidance for Industry at a public meeting at FDA’s White Oak Campus in Silver Spring, Md. -
PDA and PIC/S Offer ICH Q7 Training in Hyderbad and Ahmedabad India
Bethesda, Md., July 27, 2015 – The Parenteral Drug Association (PDA) is teaming up with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) to conduct training for pharmaceutical professionals in Hyderbad and Ahmedabad India on the International Conference on Harmonisation quality guideline Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. -
Parenteral Drug Association Education approved by N.J. Engineering Board as CPC Provider
Bethesda, Md. June 29, 2015 - The Parenteral Drug Association is pleased to announce that the New Jersey Board of Professional Engineers and Land Surveyors has approved PDA Education as a provider of courses to professional engineers for continuing professional competency (CPC) credits. -
PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Operations
Bethesda, Md., June 10, 2015 – Manufacturers of sterile drug products devote significant resources on programs to control microbial contamination in their products/processes. Bioburden and biofilm management is a significant aspect of microbial control strategies. Persistent bioburden and biofilm problems have been directly linked to several recalls and plant shutdowns. -
PDA Announces Support for the Johnson & Johnson Kilmer Conference
Bethesda, Md., May 28, 2015 – The Parenteral Drug Association (PDA) proudly announces that it will be a supporting organization of the Johnson & Johnson Kilmer Conference on sterility assurance and sterilization in 2016. -
U.S. FDA Deputy Commissioner Dr. Robert Califf to give 2015 PDA/FDA Jt. Regulatory Conf. Keynote Talk
Bethesda, Md., May 14, 2015 – The Parenteral Drug Association (PDA) today is pleased to announce that Robert Califf, MD, U.S. FDA Deputy Commissioner of the Office of Medical Products and Tobacco will deliver the keynote address at the 2015 PDA/FDA Joint Regulatory Conference, September 28-30, Washington, DC. -
PDA Extends Richard M. Johnson as President/CEO for Six Additional Years
Bethesda, Md., May 6, 2015 – The Parenteral Drug Association (PDA) Board of Directors today announced that it has finalized agreement with Richard M. Johnson to continue as President and CEO through 2021. -
PDA Education Adds Equipment to Training and Research Institute, Releases Information Video
Bethesda, Md., April 2, 2015 – PDA Education, part of the Parenteral Drug Association (PDA), announces the installation of new equipment in the Training and Research Institute (TRI) in Bethesda. -
Media Advisory/Press Conference
A press conference to provide updates on PDA’s Manufacturing Science ProgramSM, Aseptic Processing Points to Consider and other activities in 2015 -
PDA Announces Open Access of Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages
Bethesda, Md., February 18, 2015 – The Parenteral Drug Association (PDA) today announced that it is releasing Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages (TR-68) to the public for free in an effort to reduce potential drug shortages caused by manufacturing quality issues. -
PDA Launches Manufacturing Science Program<sup>SM</sup>
BETHESDA, Md., January 22, 2015 – The Parenteral Drug Association (PDA) today announced the launch of its new Manufacturing Science ProgramSM: Enabling Pharmaceutical Manufacturing’s Future. -
Industry Partnership Offers Event Attendees Unparalleled Learning, Networking and Technology Opportunities
NEW YORK, NY, BETHESDA, MD; January 20, 2015 – International Pharmaceutical Expo (INTERPHEX), the premier pharmaceutical and biopharmaceutical event dedicated to innovation, technology and knowledge, and its premier sponsor, Parenteral Drug Association (PDA), the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community, have partnered to bring to those involved in bio/pharmaceutical manufacturing unrivaled exposure to education, networking and technology. -
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. -
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. -
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. -
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. -
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. -
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. -
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. -
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.