Press Releases (Card Grid)

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.

Headlining the year’s events are five signature meetings: the PDA Annual Meeting in Orlando, Florida (March 19-21), which is followed by a workshop on manufacturing intelligence (March 21-22); the 3rd PDA Europe Annual Meeting in Berlin, Germany (June 26-27); the PDA/FDA Joint Regulatory Conference in Washington, DC (Sept. 24-26), which is followed by a workshop on biosimilars (Sept. 26-27); The Universe of Pre-Filled Syringes and Injection Devices in Orlando, Florida (Oct. 8-9), which is followed by a workshop on combination products (Oct. 10); and the 13th Annual PDA Conference on Pharmaceutical Microbiology in Bethesda, Md. (Oct. 15-17), which is followed by a workshop on endotoxins (Oct. 17-18).

PDA once again is collaborating with INTERPHEX (Apr. 17-19, New York, N.Y.), and will offer lectures at the large trade show in the Jacob K. Javits Convention Center.

Hot topics in pharmaceutical manufacturing and regulation are also addressed in 2018 with the following meetings: the PDA Europe Parenteral Packaging Conference (Feb. 27-28, Rome); PDA Sterile Medicinal Products Manufacturing Conference (May 14-15, Bethesda); PDA Europe Advanced Medicinal Productions Manufacturing Conference (June 5-6, Amsterdam); PDA Cell and Gene Therapy Conference (Oct. 23-24, Bethesda), and more.

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.

2018 PDA Glass Quality Conference in Washington features the participation of experts from pharma companies like Merck & Co. and Novo Nordisk A/S, glass experts from several vial vendors, including Corning Pharmaceutical Technologies, Nipro PharmaPackaging, and Nuova Ompi, who will discuss the latest advances to provide higher quality containers for injectable products. The U.S. FDA will be represented by David Jaworski, Senior Policy Advisor, CDER, and Sau “Larry” Lee, PhD, Deputy Director of the Office of Testing and Research, CDER.

Parenteral Packaging in Rome features an entire track on parenteral glass that will include talks from Corning, OMPI, Schott and other glass manufacturing vendors. Other tracks will explore challenges of parenteral manufacturing that can result in other glass-related quality issues, such as breakage, and container closure integrity. Representatives from the U.S. FDA, WHO and MHRA are expected.
Glass packaging continues to present challenges to manufacturers of parenteral products, yet it remains an important packaging component for the industry. Ongoing problems are highlighted by a Jan. 4 U.S. FDA announcement of an injectable product recall because of glass particles in the product vial.

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. The workshop, held at the Berlin Hilton, precedes the 2nd PDA Europe Annual Meeting.

Andrew Hopkins, MHRA, and Beate Reuter, Landesamt fur Soziale Dienste, offered highlights of the much anticipated revision to open the one-day workshop. They said the revision is thorough and necessary after years of piecemeal changes to the 40-year-old guidance. The guidance will emphasize the need for manufacturers of sterile drug products, which include vaccines and most other biologic therapeutics, to adopt modern manufacturing tools like isolators and single-use systems.

Hopkins stressed that outdated methods that necessitate operators in a Grade A room reach over product are not acceptable modern processes, even if the guidance will not specially forbid the practice. He warned that modern single-use closed systems are not a panacea.

The revised guidance will emphasize quality risk management approaches and remove settle plate averages. It will not remove pre-use post sterilization integrity testing, commonly referred to in the industry as PUPSIT.

Workshop attendees discussed a number of issues related to the guidance. A great deal of time was spent discussing container closure integrity and environmental monitoring. Participants also expressed hope that the US FDA will look to the Annex 1 when it updates its 13-year-old aseptic guide.

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."

"The Medicine Maker 100 Power List 2017" is divided into four categories of 25 "outstanding professionals." The PDA-related professionals appear in the "Industry Influencers" segment of the Power List, with Johnson and Van Trieste listed as the top one and two influencers, respectively, Jornitz ranked eighth and Agalloco ranked 11th.

Last year, Van Trieste and Agalloco were also on the Power List, which was not segregated into different categories.

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.

“With a membership comprised of subject-matter-experts on a variety of subjects, PDA already had in place a rigorous peer review process for our technical report program that includes review and approval by various advisory boards and our Board of Directors,” said Richard Johnson, PDA President. “It does not require a great leap for PDA to move into the standards-setting arena.”

PDA was approved by ANSI to be an ASD because PDA’s portfolio of technical reports, which has grown to nearly 80 active documents, includes a number of topics that are excellent candidates to become American National Standards. In addition, PDA a long history of working with other organizations, including the United States Pharmacopiea (USP) and the American Society of Mechanical Engineers (ASME), to ensure PDA’s activities do not duplicate or contradict other recommended practices.

“PDA’s science program historically has addressed topics that fill gaps that exist in existing regulations and standards used by manufacturers of sterile drug products,” said Richard Levy, PhD, PDA Sr. VP of Scientific and Regulatory Affairs. “Our series of technical reports on aseptic processing and sterile manufacturing, microbiology, and drug/device packaging and delivery systems, such as prefilled syringes,  are examples of documents that would be good candidates to become American National Standards.”

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.

The centerpiece of the buildout is a new 400 sq. ft. ISO Class 8 cleanroom that will house additional hands-on aseptic processing training courses. The cleanroom is enclosed by modular walls from Servicor and the air is processed with a HEPA air system.

"The hands-on aseptic processing instruction offered in an industrial setting at the Training and Research Institute is a critical component of PDA's educational program," said Craig Elliott, PDA Vice President of education. "PDA Education's Aseptic Processing Training Program provides an in-depth experience with the technologies associated with the manufacture of aseptically produced products, and now we have the capacity to train even more professionals each year."

PDA's aseptic processing program is highly valued and effective. "We've seen a dramatic increase in training demand recently, particularly from US regulators.  Last year PDA trained over 300 US FDA personnel, but could not keep up with the increasing demand.  This new capacity will allow us to meet the needs of the industry and the demand from regulators around the world," said Elliott.

PDA leads the pharmaceutical/biopharmaceutical industry in developing technical information and training in the areas of sterile drug manufacturing, aseptic processing, and other areas related to the manufacture and distribution of parenteral drug products.

"We offer a comprehensive and authoritative program in sterile manufacturing and aseptic processing that includes technical publications, articles, training and conferences," said Richard Johnson, PDA President.

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.

The five speakers are:

• Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA
• Seyoum Senay, MS, Lead Informatics Platform - EDM, OBI, FDA
• Jeffrey C. Baker, PhD, Deputy Director, Office of Biotechnology Products, CDER, FDA
• Mary Malarkey, Director, CBER, FDA
• William MacFarland, MS, MBA, Supervisory Biomedical Engineer, FDA

PDA is working with FDA to confirm the participation of several other CDER officials and with the UK’s Medicines and Healthcare Products Regulatory Agency to confirm one of their officials. The conference also will have broad industry and academia participation, including speakers from Amgen, Johnson and Johnson, Sanofi Pasteur, Hovione, the University of St. Gallen, and many others.

The meeting is the first chance for industry representatives to hear from and interact with FDA officials following the Agency’s publication of a revised draft of Submission of Quality Metrics Data Guidance for Industry. Public comments on the document were originally due in January, but FDA recently announced an extension of the public commenting period to March 27. The extension of the commenting period signals FDA's desire for as much inclusive feedback as possible, and its participation in this meeting is perfectly timed for receiving that input and having a direct dialog on the draft.

PDA conference first chance for industry to hear from/question FDA about guidance

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.

The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference, Feb. 21-22, 2017, at the Bethesda North Marriott Hotel & Conference Center, Bethesda, Md., will provide industry representatives the first chance to ask FDA officials who are involved with developing the metrics guidance/program, including Tara Gooen Bizjak, the contact person for the current draft.

“PDA is committed to providing science-based commentary on the quality metrics draft guidance, as we did with the release of the first draft in 2015,” said Richard Johnson, PDA president. “The quality metrics/culture conference will be the fourth held by PDA on this important topic since the U.S. FDA called on industry participation in 2013.”