Press Releases
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Just Released: PDA /ANSI Standard 06-2025, Quality Culture Assessment of Quality Culture Guidance Documents, Models, and Tools
This new standard provides guidance on evaluating and understanding quality culture in the pharmaceutical/medical device industry. It identifies five key focus topics critical for establishing and maintaining a mature quality culture: Leadership Commitment Communication and Collaboration Employee Ownership and Engagement Continuous Improvement, and Technical Excellence.
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PDA Releases Points to Consider Number 11 for Plasmids and Vectors in ATMP Production
This points to consider clarifies plasmid and viral vector categorization and control, quality by design concepts, control strategies, filtration, comparability, platform technologies and potency assays. -
Just Released: PDA/ANSI Standard 03-2025, Standard Practice for Quality Risk Management of Aseptic Processes
The PDA/ANSI Standard 03-2025, Standard Practice for Quality Risk Management of Aseptic Processes outlines a Quality Risk Management (QRM) method for assessing and controlling contamination risks in aseptic processing. -
The 2025 PDA Board of Directors: A Diverse Range of Interests and Expertise
PDA today released the names of its 2025 Board of Directors following fall elections by the membership. The sixteen directors represent pharmaceutical/biopharmaceutical businesses of all sizes and areas of competency across the United States, Europe and Asia. -
PDA Announces 2024 Drug Delivery Innovation Award Winners at Universe of Pre-Filled Syringes Conference
BETHESDA, Md., Oct. 22, 2024 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) today announced the winners of the 2024 PDA Drug Delivery Innovation Awards during the opening plenary session of the 2024 PDA Universe of Pre-Filled Syringes and Injection Devices conference in Phoenix, Arizona. -
Ensuring Excellence: Bridging Science and Compliance at the PDA Pharmaceutical Microbiology Conference 2024
Washington, D.C. — The Parenteral Drug Association (PDA) 2024 PDA Microbiology Conference, October 7-9, is underway at the Grand Hyatt in Washington, D.C. -
The Annual PDA/FDA Joint Regulatory Conference Draws Record Audience
Today marks the start of the PDA/FDA Joint Regulatory Conference in Washington D.C. PDA is happy to announce that they have a new record in attendees for this prestigious event with over 900 people have attended. -
Just Released: Risk-Based Approach for Prevention and Management of Drug Shortages Technical Report
TR-68 provides a practical framework that companies can leverage, a triage model to assess drug shortage risks, and templates for developing a Drug Shortage Risk Register and Drug Shortage Prevention and Response Plan at a product level. -
Parenteral Drug Association and Euromed Communications Release Second Co-published book, Industrial Pharmaceutical Microbiology: Quality Control
The new title is co-edited by Edward C. Tidswell, Merck Exec. Dir. Of Sterile and Micro QA, and Radhakrishna Tirumalai, Sr. Principal Scientist at Merck Research Laboratories. -
ANSI/PDA Standard on Cryopreservation of Cells for Cell and Gene Therapies Receives Complete Recognition Status by U.S. FDA CBER
The 2021 standard is included in a cohort of standards relevant to regenerative medicine therapies recognized either completely or partially by the Center for Biologics in 2023. -
PDA Announces Collaboration with the U.S. FDA Concerning Services for Pharma Compounders
The collaboration will extend for four years and include expanded training opportunities and an interactive, in-person and virtual interest group for individuals in the outsourcing facility and compounding pharmacy. -
Parenteral Drug Association Announces the 2024 All-Volunteer Officers and Board of Directors
Anil Sawant becomes the Chair for 2024-2025; Melissa Seymour is Chair-Elect; Sue Schniepp becomes Im. Past Chair -
PDA Announces 2023 Drug Delivery Innovation Award Winners at Universe of Pre-Filled Syringes Conference
Merck KGaA wins the Innovation Award, and the Partnership Award is given to Stevanato Group, Bayer US LLC and Vetter Pharma-Fertigung. -
PDA Announces the Jette Christensen Early Career Professional Grant in Memory of Past PDA Chair
PDA today announced the establishment of the Jette Christensen Early Career Professional Grant in memory of the Immediate-Past Chair of the PDA Board of Directors, who passed away on October 24 after a long battle with cancer. -
Parenteral Drug Association Announces Pulitzer Prize Winner Dominic Gates will speak at the 2023 PDA/FDA Joint Regulatory Conference
Gates will address the devastating consequences of quality lapses in the aerospace industry in the second plenary session on Sept. 18. -
PDA Announces Two U.S. FDA Center Directors for Opening and Closing Keynotes at the 2023 PDA/FDA Joint Regulatory Conference
Crowd-favorite sessions like Center and Compliance Office Updates, Current CGMP Compliance Trends and Topics, and Lunch with the Regulators return! -
PDA and Innerspace Partner to Develop Training Courses Using Advanced Virtual Reality Simulators for Global Pharma Industry
The first new PDA/Innerspace training course is called Fundamentals of Aseptic Processing, which will be held in Carlsbad, Calif., in July. -
PDA Announces Three Speakers from the U.S. FDA for ATMP Conference
The three confirmed FDA speakers are all from Center for Biologics Evaluation and Research (CBER) and include: Tiffany Lucas, PhD, Gene Therapy CMC Reviewer; Brenton K. McCright, PhD, Biologist; Mikhail V. Ovanesov, PhD, Branch Chief. -
2023 PDA Annual Meeting: Take Advantage of New Orleans La.
A new feature of the 2023 conference is a “free” night on Tuesday, April 4, to explore all New Orleans, La. has to offer. The Hyatt Regency New Orleans is walking distance to many of the city’s renowned tourist attractions, including the historic French Quarter, Arts District, and Mississippi Riverfront. There’s no better place from which to explore the eclectic vibrancy of New Orleans. -
2023 PDA Annual Meeting Offers Learnings in a Patient-Centric World
The 2023 PDA Annual Meeting, April 3-5, in New Orleans, La., is organized around the theme, “Back to the Future: Learning from The Past in A Patient-Centric World.” The meeting will spotlight the critical connection between our patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor.