Press Releases

Gates will address the devastating consequences of quality lapses in the aerospace industry in the second plenary session on Sept. 18.

Crowd-favorite sessions like Center and Compliance Office Updates, Current CGMP Compliance Trends and Topics, and Lunch with the Regulators return!

The first new PDA/Innerspace training course is called Fundamentals of Aseptic Processing, which will be held in Carlsbad, Calif., in July.

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.

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.

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.

Industry experts leading the Interest Group will be Marcia Baroni, Emergent BioSolutions, Rebecca Brewer, Quality Executive Partners, Gabriele Gori, Thermo Fisher Scientific, and Stephen Langille, ValSource.

The Parenteral Drug Association, Inc. (PDA) and RX Global today announced the renewal of their Premier Association Sponsorship agreement for INTERPHEX 2023, taking place April 25-27, 2023, at the Javits Center in New York City. This is the tenth year PDA has served as a Premier Association Supporter.

PDA Announces the Volunteer Members of its 2023 Board of Directors and Officers

Ascendis A/S and Phillips-Medisize A/S received PDA's Innovation Award for the SKYTROFA® Auto-Injector. The Stevanato Group and Bexson Biomedical earned the the Partnership Innovation Award for the innovation Pain Management Therapy through On-Body Injector System.

SmartSkin discussed manufacturing and quality assurance issues at the 2022 PDA/FDA Joint Regulatory Conference in Washington earlier this month and showcased its latest product innovations to PDA and FDA members. SmartSkin will also be attending the upcoming PDA Universe of Pre-Filled Syringes and Injection Devices show in Palm Springs, CA, October 18-19.

The largest conference/exhibition dedicated to this critical technology for the delivery of biological and traditional medicines returns to in-person meeting in 2022

This year’s PDA/FDA Joint Regulatory Conference will emphasize the role of implementing effective quality systems to ensure an ongoing state of control throughout the pharmaceutical product lifecycle by vigilantly managing quality risks. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management will be emphasized.

Richard M. Johnson concludes an eventful and successful 13-year term at PDA's helm, handing the reins to Glenn E. Wright, PDA COO.

Packed audience filled the seats of the plenary session and the lanes of the exhibit hall.

The Parenteral Drug Association (PDA) announces senior regulatory experts to speak during opening session of the 2022 PDA Annual Meeting, the first full in-person signature event held by PDA since 2019. The PDA Annual Meeting takes place at the Hyatt Regency in Dallas, Tx., April 4-6.

The Parenteral Drug Association (PDA) today announced the availability of ANSI/PDA Standard 02-2021 Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products.

The Parenteral Drug Association (PDA) today announced the results of the 2021 Board of Directors Election for the term beginning January 1, 2022.

The Parenteral Drug Association (PDA) today announced the winners of the 2021 PDA Drug Delivery Innovation Awards during the opening plenary session of the 2021 PDA Universe of Pre-Filled Syringes and Injection Devices.

The Parenteral Drug Association (PDA) today announced the availability of its newest membership type, the Early Career Professional.

The Parenteral Drug Association (PDA) today announced the availability of industry standard, ANSI/PDA Standard 05-2021 Consensus Method for Rating Filters for Mycoplasma, available now for purchase in the PDA Bookstore.

The Parenteral Drug Association, Inc. (PDA) has announced that Glenn Wright, Vice President of Scientific and Regulatory Affairs, was named the Chairman of the Product Quality Research Institute’s (PQRI) Board of Directors. Mr. Wright has participated in PQRI since 2003.

The Parenteral Drug Association (PDA) announced the beginning of its 75th Anniversary celebration. The 2021 PDA Annual Meeting (15–17 March) and the Honor Awards Ceremony (24 March), both virtual online events, served as the official launch of the diamond anniversary.

The Parenteral Drug Association (PDA) announced the availability of ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small and Large Virus-Retentive Filters.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced it has signed an agreement to collaborate with Deloitte Consulting, LLP and the U.S. FDA’s Compounding Quality Center of Excellence to provide training to large pharmaceutical compounders in a variety of Good Manufacturing Practices (GMP)-related functions critical to improving the overall quality of compound drugs.

Enables Access to Healthcare Coverage for their members with Immediate Savings and Simple Enrollment

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of the 2020 Board of Directors Election for the term beginning January 1, 2021.

Bethesda, Md., – The Parenteral Drug Association (PDA) announced the winners of the 2020 PDA Drug Delivery Innovation Awards at the 2020 PDA Universe of Pre-Filled Syringes and Injection Devices, Oct. 5-8, a virtual event. Awardees were recognized for their technical innovations in advancing the field of bio/pharmaceutical delivery devices.

Bethesda, Md., – The Parenteral Drug Association (PDA) and BioPhorum today announced that the Sterile Filtration Quality Risk Management (SFQRM), jointly created by the two organizations, has completed its final publication to help clarify industry thinking on the implications of pre-use post-sterilization integrity testing (PUPSIT) of sterilizing filters. The work product includes two research papers and two points-to-consider technical documents.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced that it has confirmed Douglas Throckmorton, MD, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), U.S. FDA, as an opening plenary speaker of the 2020 PDA/FDA Joint Regulatory Conference, which will be held virtually Sept. 14 – 16.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing for public comment. To receive a copy of this draft standard, email PDA at [email protected]. The public comments period concludes September 7, 2020 EDT. There is no charge for the draft standard.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of a new website for the PDA Foundation, a 501(c)(3) nonprofit founded in 1997 to help support PDA and other industry activities. This new website makes it easier for industry stakeholders to donate money for various activities, as it includes an online processing system.

Bethesda, Md. – The Parenteral Drug Association, Inc. (PDA) today announced two new volunteer opportunities and changes to its Board of Directors/Executive Committee following its spring Board of Directors meeting.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of ANSI/PDA Standard 001-2020, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices, and Combination Products Industries, which was approved by the ANSI Board of Standards Review on March 13, 2020.

Bethesda, Md. – The Parenteral Drug Association, Inc. (PDA) today announced the availability of its 2020 – 2026 Strategic Plan, which was developed to assist PDA in achieving its vision to be the premier global leader in advancing bio/pharmaceutical manufacturing, science, technology, and regulation to enable members to better serve patients. The plan was developed by PDA’s Strategic Planning Committee at the direction of the PDA Board of Directors.

Bethesda, Md. – The Parenteral Drug Association (PDA) announced that it is suspending membership expirations retroactively to March 1 and continuing until the end of June. All members will continue to enjoy the benefits of membership, even if you are unable to pay due to the impact of the corona virus pandemic.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the appointment of former Eli Lilly and Co. - Executive Glenn E. Wright as Vice President of Scientific and Regulatory Affairs, effective March 23. Mr. Wright most recently worked as Senior Director of Quality Operations at Exelead, a contract manufacturer. Mr. Wright also has worked for Amgen and Pfizer.

Berlin – Parenteral Drug Association Europe (PDA EU) is hosting its 10th Parenteral Packaging Conference in Basel, Switzerland, 25-26 February. The conference features presentations and discussions by industry leaders and technical experts from pharma and supplier companies. This year’s event includes expert discussions on the EU’s Medical Device Regulation 117 and on closed system transfer devices.

Bethesda, Md. – The Parenteral Drug Association (PDA) and the Association for the Advancement of Medical Instrumentation (AAMI) today announced their agreement to explore collaborations to further the missions of both organizations and enhance value to their members, stakeholders, and their respective communities at large. The two heads of each organization met at PDA’s headquarters on Jan. 29 to sign a collaboration agreement.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced its schedule of U.S. conferences for the year. The busy schedule includes PDA’s signature events and new “hot topic” workshops.

Bethesda, Md., / Brussels, Belgium – The Parenteral Drug Association (PDA) and the International Pharmaceutical Excipients Council Federation (IPEC) as an outcome of its collaboration established in March 2018, today announce the joint publication of a Technical Report for Formalized Risk Assessment for Excipients.

Berlin – The Parenteral Drug Association (PDA) Europe today announced its 2020 events calendar, which includes nine conferences throughout the EU. These events are developed by all-volunteer subject-matter experts who work with PDA staff to help educate pharmaceutical professionals on important topics related to biopharmaceuticals, manufacturing science, and regulatory affairs.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of its Board of Directors Election for the term beginning January 1, 2020. Each year, PDA’s global membership votes to select new directors for the nonprofit Association’s all volunteer Board of Directors, and the Board appoints one Director. In odd years, the membership elects new volunteer officers, who serve two-year terms (except for the chair elect, who serves for six years as chair-elect, chair, and, finally, as immediate-past-chair).

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce that its “ICH Q7 GMP for APIs” online training module is now endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use as an “ICH Recognised Training Programme.”

Bethesda, Md., – The Parenteral Drug Association (PDA) today announced the participation of U.S. FDA Center for Drug Evaluation and Research Director (CDER), Janet Woodcock, MD, and Johns Hopkins University researcher and author, Thomas Stanton, MA/JD, as keynote speakers for the 2019 PDA Risk Management in the Regulatory Landscape Conference, at the Capital Hilton, Washington, DC, Dec. 9–10. The conference is the first of three during PDA’s first “Quality Week.”

Bethesda, Md. – The Parenteral Drug Association (PDA) announced FujiFilm Kyowa Kirin Biologics, Co., Ltd. has won PDA’s new Drug Delivery Innovation Award and Congruence Medical Solutions and Santen Pharmaceuticals have won PDA’s Partnership in Drug Delivery Innovation Award. The Drug Delivery Awards were introduced in 2019 to recognize technical innovation advancing the field of bio/pharmaceutical manufacturing.

Bethesda, Md. – The Parenteral Drug Association (PDA) and the International Society for Pharmaceutical Engineering (ISPE) today announce the joint publication of a guide for Root Cause Analysis (RCA) to help the pharmaceutical industry improve quality culture by providing recommendations for tools, techniques, and processes.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 01-201x, Enhancing Purchasing Controls to Support the Biopharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industry for public comment.

Bethesda, Md. – PDA is excited to announce the keynote speakers for the upcoming PDA/FDA Joint Regulatory Conference September 16-18 in Washington, D.C. These and other expert speakers will share their insight on how to improve the continued supply of high-quality drugs, biologics, and novel combination products to patients.

The Parenteral Drug Association (PDA) today announced representatives of seven health authorities have been invited to speak at the 2019 PDA Europe Biomanufacturing Conference, 3-4 September 2019 in Munich, Germany.

Bethesda, Md. – PDA today announces the official launch of its third standard project, “Standard Practice for Quality Risk Management of Aseptic Processes” which is being chaired by Hal Baseman, Chief Operating Officer of ValSource, Inc.

Bethesda, Md. – The Parenteral Drug Association (PDA) is excited to host its 4th Annual European Meeting: Global Healthcare of the Present and the Future, June 25-26 in Amsterdam, The Netherlands, the new location of the European Medicines Agency, where industry and regulatory agencies will present their perspectives on the transformation unfolding in the pharmaceutical sector regarding the digitalization and automation of manufacturing processes.

Bethesda, Md. – The Parenteral Drug Association (PDA) is pleased to announce the speaker lineup for the 2019 PDA EU Advanced Therapy Medicinal Products: Cell and Gene Therapy – From Promise to Cure Conference, in Vilnius, Lithuania, June 4-5. Expert speakers representing industry, government and academia will cover the full breadth of scientific and regulatory considerations for successfully launching and manufacturing cell and gene therapies.

Bethesda, Md. – The Parenteral Drug Association (PDA) is once again well-represented on “the Medicine Maker” Power List—a list that celebrates pharmaceutical professionals for efforts to improve the industry in various ways. PDA President & CEO Richard Johnson, past-chairs Hal Baseman, Maik Jornitz and James Agalloco are recognized on the “Industry Influencer” list and past-chair Martin Van Trieste is on the “Champions of Change” list.

Bethesda, Md., – The Parenteral Drug Association (PDA) is proud to present the second annual Pharmacopoeia Conference, at the Crown Plaza Geneva, Switzerland, May 16-17.

Bethesda, Md. – The Parenteral Drug Association (PDA) today confirmed five speakers representing global pharmaceutical regulatory agencies at the 2019 PDA Biosimilars and Vaccines Conference: Lifecycle Similarities and Challenges, at the Hilton Long Beach, Long Beach, Calif., May 9 – 10, 2019.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced that Yonghua Gao, Deputy Secretary General at the China National Pharmaceutical Packaging Association will present a regulatory update of China’s packaging laws at the 2019 PDA Europe Parenteral Packaging Conference, March 19 – 20, at the Hilton Molino Stucky Venice, Italy.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the opening of PDA Asia Pacific, the U.S.-based Association’s second overseas office.

Bethesda, Md., – The Parenteral Drug Association (PDA) announced plans to release the results of its 2019 Technology Transfers Survey during the 2019 PDA Annual Meeting at the Marriott Marquis San Diego, Calif., March 11 – 13. The survey results will be discussed at the Technology Transfer Interest Group session on Tue., March 12, 10:45 – 12:15.

Bethesda, Md., – The Parenteral Drug Association (PDA) today announced plans to offer its industry-leading courses in pharmaceutical science and aseptic processing in Bangalore, India to serve the industry at-large there. The first course, Aseptic Techniques, will be held in March 2019 and the final course, Microbial Data Deviations will be held in November.

Bethesda, Md. – The Parenteral Drug Association (PDA) is excited to announce the launch of its new-look website, www.pda.org.

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of its Board of Directors Election for the term beginning January 1, 2019. In the fall of 2018, PDA’s 10,500 members had an opportunity to participate in the election of new directors.

Bethesda, Md. – The Parenteral Drug Association (PDA) is pleased to announce the formation of a PDA technical report team and a task force to advance projects to assist pharmaceutical manufacturers in key areas. Both projects were approved by the PDA Science Advisory Board and have spun out of PDA’s umbrella Manufacturing Science and Operations ProgramSM, which is an advisory body to PDA of leading experts in pharmaceutical manufacturing.

Bethesda, Md. – The Parenteral Drug Association (PDA) announced the formation of the Pacific Northwest Chapter, its newest chapter. The PDA Board of Directors voted to accept the chapter’s charter and its board of volunteer officers at its September meeting in Washington, DC. The chapter will provide a local forum through which technical professionals in Washington, Oregon, Idaho, Alaska, and British Columbia can support the advancement of pharmaceutical and biopharmaceutical science and technology.

Bethesda, Md. – The Parenteral Drug Association (PDA) has released its Call for Abstracts for the 2019 PDA Europe Parenteral Packaging Conference: Interaction of Product, Package and Process, 19-20 March 2019 at the Hilton Molino Stucky in Venice, Italy.

Bethesda, Md., August 17, 2018 – The Parenteral Drug Association (PDA) is pleased to announce the agenda for the 2018 PDA Biosimilars Workshop, “Getting it Right the First Time for Biosimilar Marketing Applications,” which will be held at the Renaissance Washington DC Downtown Hotel, Sept. 26 – 27.

Bethesda, Md. – The Parenteral Drug Association’s (PDA) Manufacturing Science and Operations ProgramSM (MSOP) Manufacturing Intelligence Task Force will present an update on its activities on Tuesday June 26 at 15:20 CET during the PDA Europe 3rd Annual Meeting at the Berlin Marriott.

Intelligence report analyzes link between post approval change regulations and drug shortages

Bethesda, Md., June 4,2018 – The Parenteral Drug Association (PDA) is advancing its activities involving the recent release of the draft revision to EU GMP Guideline Annex 1, the European guideline for sterile medicinal products with a recent in-depth workshop on the topic and the formation of a consortium to address pre-use and post-sterilization integrity testing for sterilizing grade filters (PUPSIT).

Bethesda, Md., May 14, 2018 – The Parenteral Drug Association, Inc. (PDA) is pleased to announce that President & CEO Richard Johnson and past Chairs Martin Van Trieste, Maik Jornitz, Harold Baseman, and James Agalloco have been recognized by The Medicine Maker as among the top 25 “Industry Influencers” in 2018.

Bethesda, Md., May 7, 2018 – The Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineers (ISPE) announced today that they have signed a Memorandum of Understanding (MOU) to exchange information regarding their respective efforts on Quality Metrics and Quality Culture.

Bethesda, Md., April 30, 2018 – The Parenteral Drug Association (PDA) is proud to present its inaugural Pharmacopoeia Conference held at the Renaissance Wien Hotel, May 29-30, Vienna, Austria, which features lectures from representatives of the pharmacopoeias for Europe, the United States, Russia, China, Japan, India, and Ghana. The European Directorate for Quality of Medicines & Healthcare (EDQM) is chairing the conference.

Bethesda, Md., April 23, 2018 – The Parenteral Drug Association (PDA) is pleased to announce that Tina Morris, PhD, has been named Vice President of Scientific and Regulatory Affairs, effective June 4, 2018. Dr. Morris currently serves as Sr. VP of Compendial Sciences at the U.S. Pharmacopeia, with whom she has worked for 15 years.

Bethesda, Md., April 13, 2018 – The Parenteral Drug Association (PDA) announced today that it is expanding its pharmaceutical packaging program with the addition of two trainings in Seoul, Korea and the publication of a book and a survey on pharmaceutical glass.

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.

Bethesda, Md., January 30, 2018 – The Parenteral Drug Association (PDA) today announced its 2018 events calendar, which includes 35 conferences and workshops. These events are developed by all-volunteer subject-matter experts who work with PDA staff to help educate pharmaceutical professionals on important topics related manufacturing science, quality and regulatory affairs.

Bethesda, Md., January 12, 2018 – The Parenteral Drug Association, Inc. (PDA) announced today the speaker line-ups for its parenteral glass/packaging conferences taking place Jan. 23-24 at the Omni Shoreham Hotel in Washington, DC and Feb. 27-28 at the Marriott Rome Park Hotel in Rome.

Bethesda, Md., November 28, 2017 – The Parenteral Drug Association (PDA) today announced the results of its Board of Directors Election for the term beginning January 1, 2018. The 2017 election included candidates for the Board’s Executive Committee and four Director positions.

Bethesda, Md., November 20, 2017 – The Parenteral Drug Association (PDA) gathered experts in pharmaceutical manufacturing, big data and manufacturing intelligence for a “Big Data & Insights from the Shop Floor” ideation session.

Bethesda, Md., October 25, 2017 – The Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineers (ISPE) today released a joint statement confirming their combined commitment to fulfilling their respective missions and guiding their members and stakeholders toward using the best science and engineering to continue to provide high-quality, safe, and effective medicines to serve patients. The two not-for-profit membership associations also affirmed their commitment to continuing our collaborations that provide unbiased platforms for dialogue to benefit the global pharmaceutical and biopharmaceutical community.

Bethesda, Md., August 31, 2017 – The Parenteral Drug Association (PDA) published Points to Consider for Aging Facilities as part of an ongoing focus on manufacturing improvements. In some cases, noncompliant, aging facilities are a reason forcing companies to cease manufacturing, which may exacerbate drug shortages.

Bethesda, Md., July 28, 2017 – The Parenteral Drug Association (PDA) today announces the results of its pharma/biopharma survey regarding the impact of national-level post-approval change regulations on company’s ability to innovate.

Bethesda, Md., June 12, 2017 – The Parenteral Drug Association (PDA) today announced the successful completion of its Annex 1 Revision Workshop, which afforded industry a final preview before the revised guidance for aseptic processing GMPs is issued as early as the end of the month.

Bethesda, Md., May 25, 2017 – The Parenteral Drug Association (PDA) is proud to announce a significant initiative to bring together executives, including CEOs and executive vice presidents, from biologic and pharmaceutical manufacturers with glass container and elastomeric closure suppliers to prepare industry for the complex products and manufacturing processes of the future.

Bethesda, Md., May 15, 2017 – The Parenteral Drug Association (PDA) today announced the publication of Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems,which provides a practical guide on how to manage quality risks throughout the manu­facturing system lifecycle. Technical Report 54-5 includes two case studies illustrative of the concepts developed in the main body of the document. In June, PDA is sponsoring the 2017 Quality Risk Management for Manufacturing Systems Workshop,which will cover the concepts elucidated in Technical 54-5, at the Hyatt Centric Chicago Magnificent Mile, Chicago, Ill., June 19-20.

Bethesda, Md., May 8, 2017 – The Parenteral Drug Association, Inc. (PDA) is pleased to announce that President & CEO Richard Johnson, volunteer Chair Martin Van Trieste, and past chairs Maik Jornitz and James Agalloco have been recognized by The Medicine Maker among the "top 100 individuals involved in bettering the pharma industry and bringing life-changing medicines to market."

Bethesda, Md., May 3, 2017 – The Parenteral Drug Association (PDA) today released the names of confirmed health authority speakers at its 2017 Revision of Annex 1 Workshop, at the Hilton Berlin, June 12, 2017, which precedes the 2nd PDA Europe Annual Meeting: Global Healthcare of the Present & Future, June 13-14.

Anaheim, Ca. April 3, 2017 – The Parenteral Drug Association (PDA) today announced that it has been approved by the Executive Standards Council (ExSC) of the American National Standards Institute (ANSI) as an Accredited Standard Developer (ASD). The announcement was made during the opening session of PDA’s Annual Meeting at the Anaheim Marriott.

Bethesda, Md., March 2, 2017 – The Parenteral Drug Association (PDA) today announced the availability of two “PDA Papers” authored by the Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force in the “Accepted Articles” section of the PDA Journal of Pharmaceutical Science and Technology (PDA Journal).

Bethesda, Md., February 27, 2017 – The Parenteral Drug Association (PDA) today announced the completion of a six-month enlargement of its Training and Research Institute (TRI) in Bethesda. The expansion permits PDA Education to increase its capacity for hands-on aseptic processing and lecture-based training at TRI.

Bethesda, Md., February 8, 2017 – The Parenteral Drug Association (PDA) today announced that five U.S. FDA experts are confirmed speakers at the 2017 PDA Pharmaceutical Quality Metrics and Culture Conference at the Bethesda North Marriott & Conference Center, Feb. 21-22.

Bethesda, Md., November 30, 2016 – The Parenteral Drug Association (PDA) is preparing comments on the U.S. FDA’s revised draft guidance for industry: Submission of Quality Metrics Data. The revised draft was issued after strong public interest and comment on the first draft, which was published in 2015.

Bethesda, Md., November 18, 2016 – The Parenteral Drug Association (PDA) marks its 70th Anniversary in November. PDA’s original Certificate of Incorporation was signed in November 1946 by its six original directors: Harold London, Rudolph Price, A. Lincoln Konwiser, Max Gold, Arthur Herrick, and Abraham Wagner.

Bethesda, Md., September 19, 2016 – The Parenteral Drug Association (PDA) has announced its program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes

Bethesda, Md., August 12, 2016 – The Parenteral Drug Association (PDA) Education—Where Excellence Begins—announces the development of five specialized courses for officials in the U.S. FDA’s Center for Drug Evaluation and Research, commencing in September and running through early 2017.

Bethesda, Md., July 26, 2016 – The Parenteral Drug Association (PDA) proudly announces the appearance of more than 25 U.S. FDA officials as speakers and moderators for the Silver, 25th Anniversary PDA/FDA Joint Regulatory Conference at the Renaissance Washington, DC Downtown Hotel, September 12-14, 2016.

Bethesda, Md., July 21, 2016 – The Parenteral Drug Association (PDA) invites pharmaceutical professionals and regulatory officials to participate in a 2-day, experienced-based training course on the application of good manufacturing practices (GMPs) regulations to active pharmaceutical ingredients (APIs) production in San Juan, Puerto Rico, August 8-9.

Bethesda, Md., June 2, 2016 – The Parenteral Drug Association, Inc. (PDA) announced the participation of four confirmed officials from the U.S. FDA at its Biosimilars Conference, cosponsored with the Product Quality Research Institute, at the Hilton Baltimore, Baltimore, Md., June 20-21.

Bethesda, Md., May 19, 2016 – The Parenteral Drug Association (PDA) today launched a pilot for its Quality Culture Assessment Tool with an assessor training session. Members of PDA’s Quality Culture Maturity Task Force met with six auditors from two companies to introduce the assessment tool and learn how to apply it to simulated manufacturing case studies.

Bethesda, Md., May 10, 2016 – The Parenteral Drug Association, Inc. (PDA) is pleased to announce that its current volunteer Chair Martin Van Trieste (Amgen) and one of its past chairs, James Agalloco, have been recognized by The Medicine Maker among the “top 100 most influential people in the world of drug development and manufacture.”

NEW BRUNSWICK, N.J. (May 6, 2016) – The Parenteral Drug Association, Inc. (PDA) was presented with the Kilmer Award in recognition of the Association’s longstanding leadership in contributing to the science of sterility assurance.

San Diego, Ca., April 19, 2016 – The Parenteral Drug Association, Inc. (PDA) opened its two-day workshop on current challenges in aseptic processing with a challenge to the younger attendees to question “why and why not” in regard to the way their companies manufacture sterile drug products.

Bethesda, Md., March 11, 2016 – The Parenteral Drug Association (PDA) is rolling out resources for pharmaceutical companies to use for strengthening the integrity of their manufacturing and quality data as part of a comprehensive effort to assist the industry with this sensitive and important area.

Bethesda, Md., February 9, 2016 – The Parenteral Drug Association, Inc. (PDA), the leading community for pharmaceutical professionals developing and manufacturing sterile drug products, today announced the publication of Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet.

Bethesda, Md., December 8, 2015 – The Parenteral Drug Association (PDA) announced the results of its Board of Directors election, including newly elected members to the Executive Committee.

Bethesda, Md., November 18, 2015 – The Parenteral Drug Association (PDA) has announced a change in leadership for its education programs.

Bethesda, Md., November 4, 2015 – The Parenteral Drug Association (PDA) is sponsoring its third conference on quality metrics Nov. 9-11 at the Bethesda North Marriott Hotel and Conference Center.

Bethesda, Md., October 27, 2015 – The Parenteral Drug Association (PDA) is once again hosting its Universe of Pre-Filled Syringes and Injection Devices conference in Europe. The November 3-4 event takes place in the Austria Center Vienna. This year, 103 vendors will be on hand to display their products and solutions for pharmaceutical companies looking to offer their products in these devices, which are rapidly becoming standard for injectable products.

Bethesda, Md., October 22, 2015 – In addition to the leading forum for visual inspection of parenteral products, the Parenteral Drug Association (PDA) is proud to offer the largest exhibition of commercial visual inspection hardware at the 2015 Visual Inspection Forum in Bethesda, Md., October 26-27.

Bethesda, Md., October 14, 2015 – The Parenteral Drug Association (PDA) is celebrating the tenth anniversary of its Annual Global Conference on Pharmaceutical Microbiology. This annual event brings together microbiologists throughout the industry and regulatory bodies to discuss the latest trends in microbial testing, sterilization technology, and other topics of interest to this scientific community.

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.

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.

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.

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.

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.

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.

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.

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.

A press conference to provide updates on PDA’s Manufacturing Science ProgramSM, Aseptic Processing Points to Consider and other activities in 2015

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.

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.

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.

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.

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.

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.

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.

Bethesda, Md., September 19, 2014 – The Parenteral Drug Association (PDA) is moving forward with an initiative to harmonize global post-approval changes protocols.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Bethesda, Md. - The Parenteral Drug Association announced the results of its 2014 Board of Directors and Officers Elections. All those elected begin their terms in January 2014

Bethesda, Md. - Producing sterile products using aseptic processing technology is challenging and the FDA is aware of these challenges. Therefore the agency places a major emphasis on this area as part of its oversight responsibility.

Bethesda, Md. – 45 pharmaceutical professionals have formed the Singapore chapter of PDA, bringing to 24 the number of chapters across the globe.

Bethesda, Md. – Many of the nearly 1,000 people who attended the 23rd Annual PDA/FDA Joint Regulatory Conference said the event provided them the opportunity to hear directly from regulators on the issues that affect them most, and from industry experts on how they are responding to these same issues.

Bethesda, Md., For government regulators across the globe, the Parenteral Drug Association is offering free or greatly reduced electronic membership fees.

Bethesda, Md., When the topic of single use systems comes up among pharmaceutical manufacturers, there seems to be more questions than answers.

Bethesda, Md., For members of the Parenteral Drug Association, this is election season – for open seats on the 2014 Board of Directors.

Although Polymer as a container material for medicinal products has been accepted as an alternative to glass in certain regions and many applications, it is still not always seen as a first choice alternative for pre-filled syringes. However, development and acceptance of polymer as a packaging material has come a long way. Ten years ago, polymer was merely an exotic material for pre-filled syringes. Even though it was already well accepted e. g. in flexible bags (LVP) then, its use in prefilled syringe applications did not attract much attention.

NORWALK, CT, Aug. 19, 2013 – International Pharmaceutical Expo (INTERPHEX), the leading annual trade event dedicated to the pharmaceutical and biopharmaceutical industry and the Parenteral Drug Association (PDA) are pleased to announce a three-year Sponsorship Agreement.

PDA announced today that Richard Friedman, Associate Director OMPQ, U.S. FDA, and Rebecca Rodriguez, Consumer Safety Officer, U.S. FDA, have been confirmed to deliver the closing plenary talks at the 2013 Human Factors and Human Error Reduction Workshop.

Bethesda, Md., February 1, 2012 – The Parenteral Drug Association (PDA) is proud to announce the founding of the PDA Texas Chapter, which will serve PDA members in that area.

Bethesda, Md., January 7, 2013 – The Parenteral Drug Association (PDA) is proud to announce the establishment of the Martin VanTrieste Pharmaceutical Science Award.

PDA is pleased to announce the results of the 2013 Board of Directors and Officers election. The elected candidates will fill their term beginning on January 1, 2012. Thank you to all who voted!

PDA is pleased to announce the results of the 2013 Board of Directors election. The elected candidates will fill their term beginning on January 1, 2013. Thank you to all who voted!

PDA Technical Reports are highly valued, global technical documents prepared by member-driven Task Forces comprised of content experts, including scientists and engineers working in the pharmaceutical and biopharmaceutical industry, regulatory authorities and academia.

Bethesda, Md., October 31, 2012 – The Parenteral Drug Association (PDA) is proud to announce the founding of the PDA India Chapter, which will serve PDA members in India.

“This is the most innovative and significant member benefit ever offered by The Parenteral Drug Association (PDA),” said Richard M. Johnson, PDA President. “We have been working hard on enhancing our member value and we believe that releasing this new Technical Report Portal by the end of 2012 is a breakthrough benefit that you just don’t see anywhere.

Our industry is entering a challenging phase for the next decade in the area of pre-filled syringes & injection devices. Costs and regulatory demands exert downward pressure on our ability to introduce devices that are safe and effective. Patients and their needs continue to grow while ever more complex molecules continue to challenge our material selection. Regulatory requirements, industry experience and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes and injection devices to drug delivery.

Bethesda, Md., July 16, 2012 – St Petersburg, Russia (June 22, 2012) – The Parenteral Drug Association (PDA) and The Saint-Petersburg State Chemical-Pharmaceutical Academy (SPCPA) have signed a Memorandum of Understanding to develop a GMP and Regulatory Affairs Training Center in the area of pharmaceutical manufacturing in St. Petersburg (the Training Center).

The Parenteral Drug Association (PDA) is coordinating a critical discussion on the implementation of QbD concepts in vaccine development.Five vaccine manufacturers (GlaxoSmithKline, MedImmune, Merck, Pfizer and Sanofi Pasteur) have joined to form the CMC-VWG, with assistance from PricewaterhouseCoopers, to create a case study describing the development of the fictitious vaccine A-Vax. The goal of the workshop is to initiate a discussion of the case study and to provide a review of the QbD approaches employed for the development of A-Vax.

PDA is pleased to announce the results of the 2012 Board of Directors and Officers election. The elected candidates will fill their term beginning on January 1, 2012. Thank you to all who voted!

Bethesda, Md., September 7, 2011 – The Parenteral Drug Association (PDA) is pleased to announce new measures enhancing the availability of PDA membership including an expanded Emerging Economy membership, a new option for Retired Membership, and additional assistance for members who are currently seeking employment in the Pharmaceutical industry.

Bethesda, Md., August 8, 2011 – The Parenteral Drug Association (PDA) is proud to announce that Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy will give the Opening Keynote speaker at the 2011 PDA/FDA Joint Regulatory Conference & TRI Courses, Sept. 19-21, Renaissance Washington Hotel in Washington, D.C.

US FDA Commissioner, Dr. Margaret Hamburg, calls for closer and more global cooperation on GMP at PIC/S 40th Anniversary

PDA along with the US FDA hosted the 2011 PDA/FDA Glass Quality Conference & TRI Courses on May 23-26, 2011 in Arlington, Virginia. “The first-time event had great content and participation [and]...brought to the table the most relevant topics,” said Richard M. Johnson, PDA President.

PDA is working on improving member engagement and their satisfaction is at the forefront of our decision to invest in a new web site with enhanced navigation.

Hear from the US FDA, National Institute of Health and More at PDA’s 2010 Pharmaceutical Freeze Drying Workshop

PDA’s Board of Director’s Chairman, Maik Jornitz, Was Recently Promoted to Head, Operational Marketing of Sartorius Stedim Biotech.

Bethesda, Md. – PDA/FDA's Joint Regulatory Conference recently held in Washington, D.C. has been an overwhelming success with over 800 regulators and scientists attending and discussing current and upcoming regulatory trends and quality requirements.

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory speakers at this year’s Global Conference on Pharmaceutical Microbiology.

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce that Rebeca Rodriquez, National Expert Investigator, FDA is confirmed to give an Overview of Personnel Qualification Issues found during FDA Inspections in Baltimore, Maryland on October 12.

2010 PDA/FDA Joint Regulatory Conference Announces Key Industry and Government Leaders as Speakers

PDA Announces Establishment of New Chapter

U.S. FDA Commissioner to give Keynote Presentation at the 2010 PDA/FDA Joint Regulatory Conference

Top supply chain experts representing pharmaceutical manufacturers, material suppliers, auditing companies, technology enablers, and the U.S. FDA participated in lengthy, brainstorming sessions. The Parenteral Drug Association and the U.S. FDA collaborated to develop a workshop that would facilitate various stakeholders clarifying the problems and identifying practical actions.

The Parenteral Drug Association (PDA) has confirmed that Janice V. Meck, PhD, Director, Cardiovascular Laboratory, NASA-Johnson Space Center will present "Development of a Pharmaceutical Countermeasure for Post-spaceflight Orthostatic Intolerance" during the Opening Plenary Session of the 2010 PDA Annual Meeting.

In mid-November, PDA is turning over the publishing responsibilities for IPQ to Bill Paulson, who will continue to provide IPQ to PDA members on a complimentary basis for an interim period while subscription, site licensing and sponsorship opportunities are being pursued.

Berlin (October 23, 2009) – The European Medicines Agency (EMEA) told industry manufacturing, control and regulatory professionals gathered at the 2009 PDA/EMEA Joint Conference that complicated supply chains, while necessary, are a weak link in quality control.

The Parenteral Drug Association (PDA) and DHI books have published volume three of Environmental Monitoring: A Comprehensive Handbook.

U.S. FDA Deputy Commissioner Joshua Sharfstein, MD, previewed what direction the Agency’s public health policies will take under new Commissioner Margaret Hamburg, MD, during his keynote address at the 2009 PDA/FDA Joint Regulatory Meeting in Washington, D.C. on September 14.

The Parenteral Drug Association, Inc. (PDA) has announced the appointment of Richard M. Johnson as the Association’s next President, effective September 2009.

Something unique to the long-running PDA/FDA Joint Regulatory Conference will occur this year. Not only will the meeting delve deeply into the most pressing regulatory issues of the day, but its closing day will include a powerful reality check when regulatory affairs professional and breast cancer survivor Amy Giertych provides her unique perspective as both an insider and a patient.

Officials from the Shanghai Institute of Food and Drug Safety (SIFDS), a branch of the Shanghai Municipal Food and Drug Administration (SHFDA), and the Parenteral Drug Association, Inc. (PDA) celebrated the grand opening of a new office for the SIFDS/PDA Joint Development Center (SHJDC).

The Parenteral Drug Association (PDA) reached a membership and information-sharing agreement with its chapter in Taiwan, which closely supports the Taiwan FDA (TFDA).

The Parenteral Drug Association Training and Research Institute (PDA TRI) and the PDA Israel Chapter are teaming up this July to bring the Institute’s world-class training for the pharmaceutical/biopharmaceutical industry to Israel, with two courses covering regulatory hot topics.

The Parenteral Drug Association (PDA) has confirmed three keynote speakers for the 2009 PDA/FDA Joint Regulatory Conference who will discuss what the year 2020 will look like for the industry and what challenges must be overcome for the pharmaceutical industry, especially in the manufacturing segment of the industry.

The public comment period for the U.S. FDA’s draft guidance on process validation generated more activity from PDA members since the Agency published its aseptic guidance for comment earlier in the decade. More than 400 comments were submitted to PDA, which established an online tool to collect the comments.

PDA and HighWire Press officially began a partnership to create a new, modern online experience for the readers of its 63-year-old PDA Journal of Pharmaceutical Science and Technology.

PDA members who work with sterilizing and viral filters will benefit from updated best practices included in the 2008 revisions of PDA Technical Report No. 26, Sterilizing Filtration of Liquids and Technical Report No. 41, Virus Filtration.

In January 2009, Robert L. Dana, a long time PDA member, assumed new responsibilities within PDA. In his new role as Senior Vice President, Regulatory Affairs and Training and Research Institute, he will report to Bob Myers, President of PDA, and will also maintain a dotted line relationship to Rich Levy, PhD, Sr. VP, Scientific and Regulatory Affairs, PDA and will continue to serve as PDA’s regulatory authority.

The Parenteral Drug Association (PDA) has confirmed that FDA’s J. David Doleski and Nicole Trudel will co-present during the Opening Plenary Session at the 2009 PDA Annual Meeting in Las Vegas, Nevada, April 20-24, 2009.

The Parenteral Drug Association (PDA) has confirmed that Ian Morrison will speak during the Opening Plenary Session at the 2009 PDA Annual Meeting in Las Vegas, Nevada, April 20-24, 2009.

The public comment period for the U.S. FDA’s draft guidance on process validation generated more activity from PDA members since the Agency published its aseptic guidance for comment earlier in the decade.