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Press Releases

PDA Launches Pharma Quality Culture Transformation Program with Regulatory Agency Briefings

For Immediate Release:
03/26/2018
Media Inquiries:
Walt Morris
/ morris@pda.org /
301-656-5900, x. 148

Bethesda, Md., March 16, 2016 – The Parenteral Drug Association (PDA) is pleased to announce the official launch of its Quality Culture Transformation Program for pharmaceutical manufacturers. Enrollment in the Quality Culture Transformation Program gives companies access to four tools to measure and ultimately improve their commitment to quality.

Pharmaceutical regulatory agencies around the globe have shown a keen interest in the development of the PDA Quality Culture Transformation Program. The U.S. Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency lent experts to the volunteer task force that developed the Program. PDA will brief officials in the USFDA’s Center for Drugs Evaluation and Research on April 9 in Bethesda, Md. and MHRA officials on April 19 in London on the program’s elements. PDA already briefed officials from the Taiwan FDA earlier this year.

Industry is now welcome to enroll in the Program. Openings are still available for the April 17-18 session in Mainz, Germany.

Once enrolled, companies will start with training via a PDA-run course. Next, they will receive PDA’s Assessment Tool to conduct a site self-assessment. Then, they will complete PDA’s quality culture survey. The program concludes with benchmarking report that analyzes where the company/site stands vis a vis other companies completing the program.

The PDA Quality Culture Transformation Program was developed via a pilot program in 2016-2017 that involved 43 sites and 24 companies, resulting in over 63 trained assessors and benchmarking data collected from over 9000 survey respondents. Pilot participants informed PDA that the program would be useful for industry and will provide companies a “road map for improvement.