Press Releases (Card Grid)
PDA’s PAC iAM Task Force Releases Work Plan to Reduce Manufacturing Change Barriers
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. Current disharmonized national and regional “post-approval changes” regulations require companies to submit filings with agencies worldwide in order to gain permission to make most kinds of manufacturing, analytical methods and process changes. In many cases, the process takes several years, and manufacturers must produce multiple batches of the same product while they await approval for a change in one region/country, which has already been approved in others.
A PDA Post Approval Change Innovation for Access to Medicines (PAC iAMsm) Task Force of volunteer industry experts has issued a call to action, inviting the broader pharmaceutical industry and regulatory community to join with them in tackling this “wicked problem.”
“The challenge of managing various requirements and timelines to initiate manufacturing improvements has had the unintended consequence of stymieing innovation,” stated PDA president Richard Johnson. “As facilities and processes age, they are not keeping up with current technologies and practices, which in many cases lead to manufacturing stoppages and plant shutdowns and ultimately the very serious public health problem of drug shortages.”
PDA’s task force has the following objectives:
- Bring awareness to current challenges and enable stronger collaboration amongst opinion leaders and key stakeholders (within industry, regulatory authorities and other relevant stakeholder forums).
- Foster a science and risk-based approach to PAC management and regulatory decision making for global product quality, safety, and efficacy assessments
- Encourage international convergence / standardization in PAC management in a manner that can foster and enable mutual reliance between regulatory authorities
- Manage PACs through the use of an effective Product Quality Systems (PQS)
PDA will produce several position papers for the PDA Journal of Pharmaceutical Science and Technologyover the coming months. It also will be conducting an industry survey to gather information to support a future PDA technical report and examples of global PAC protocols on the topic.
PDA’s PAC iAM Task Force
| Anders Vinther, Sanofi Pasteur (co-lead) Ursula Busse, Novartis Marcello Colao, GSK Vaccines Maik Jornitz, G-CON Morten Munk, NNE Pharmaplan Melissa Seymour, Biogen Denyse Baker, PDA | Emma Ramnarine, Roche/Genentech(co-lead) Franck Chassant, Sanofi Pasteur Julia Edwards, Biogen Marina Kozak, Friends of Cancer Research Mihaela Simianu, PharmaCore Insights Rich Levy, PDA |
PDA Education to Offer FDA CDER Five Specialized Courses on Sterilization and Media Fills
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. The lecture courses will take place at FDA’s White Oak Campus, Silver Spring, Maryland.
The series of courses covering steam sterilization, sterile filtration and media fills will be taught by expert faculty from the industry. The courses are:
September 9, 2016
Basics of Steam Sterilization
Mike Sadowski, Director, R&D Sterility Assurance, Baxter International Inc.
October 7, 2016
Advanced Steam Sterilization
Mike Sadowski, Director, R&D Sterility Assurance, Baxter International Inc.
November 8, 2016
Media Fills
Harold Baseman, Chief Operating Officer and Principal, ValSource LLC
January 10, 2017
Container Closure Systems and Integrity Testing
Lei Li, PhD, Sr. Consultant Engineer, Delivery and Device R&D, Eli Lilly and Company
February 7, 2017
Sterilizing Filtration
Maik Jornitz, President, G-CON Manufacturing Inc.
Wayne Garafola, Field Applications Specialist - Filtration Technologies,
Sartorius Stedim North America Inc.
The training is the latest example of PDA’s long history of providing expert training to regulators worldwide. The FDA has regularly participated in specialized training for aseptic processing techniques and sterilization since PDA opened the Training and Research Institute in 1997. PDA also has conducted inspectorate training with European regulators and in recent years has partnered with the cross-inspectorate organization Pharmaceutical Inspection Convention/Scheme to provide regulatory training on topics like data integrity.
About PDA Education – Where Excellence Begins
Built on a reputation of excellence and founded in science, PDA Education courses provide new and experienced professionals alike with practical information and implementable solutions related to essential industry topics.
PDA Announces over 25 FDA Officials at Podium for 25th PDA/FDA Joint Regulatory Conference
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.
The 2016 PDA/FDA Joint Regulatory Conference will be "celebrating 25 years of addressing global regulatory strategy" with a mix of presentations by U.S. FDA officials and the corresponding industry perspectives by high-level pharmaceutical and biopharmaceutical leaders. The following FDA centers and offices will be represented:
- Office of the Commissioner
- Center for Drug Evaluation and Research
- Center for Biologics Evaluation and Research
- Center for Veterinary Medicine
- Center for Devices and Radiological Health
- Office of Regulatory Affairs
"For 100 years, U.S. FDA regulations have been a central consideration in manufacturing pharmaceutical products for the U.S. market, and around the world. Over the last 25 years, the PDA/FDA Joint Regulatory Conference has grown into the key forum for manufacturers around the world to learn how to navigate these requirements," said PDA President Richard Johnson.
The 2016 conference is themed, "Aligning Manufacturing Goals with Patient needs through Successful Innovation and Compliance." The two-and-a-half day meeting features several plenary sessions, break-out sessions, breakfast sessions and special PDA Interest Group sessions.
Interested members of the press can request a press pass.
PDA and PIC/S Offer 2-Day Training on GMPs for Pharma Ingredients in San Juan Aug. 8-9 Regulators from around the world will be on hand at the two-day event
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. The course is part of an ongoing series of workshops on the topic GMPs for APIs cosponsored by PDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which has included similar events last year in South Korea, Brazil and India.
Regulators representing the following countries/agencies will be attending the training: Argentina’s INAME-ANMAT, Croatia’s Agency for Medicinal Products and Medical Devices (HALMED), Poland’s Main Pharmaceutical Inspectorate, Republic of Slovenia’s Agency for Medicinal Products and Medicinal Devices, Tunisia’s Ministry of Public Health, Taiwan’s FDA, and others.
The U.S. FDA is heavily represented on the podium, with speakers from both the local Puerto Rico Field Office and the Agency’s headquarters in Silver Spring, Maryland.
The focus of the two-day event is the International Conference on Harmonization (ICH) quality guideline on GMPs for APIs, referred to as ICH Q7. This document is the worldwide standard for manufacturers of active ingredients for the pharmaceutical industry.
Interested members of the press can request a “press pass”.
U.S. FDA to Speak on Biosimilars at June PDA/PQRI Conference in Baltimore
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.
Biosimilars entered the U.S. pharmaceutical market in 2015 with the U.S. FDA approval of Sandoz’s Zarxio, a biosimilar of Amgen’s Nuepogen. The U.S. Senate held hearings on biosimilars shortly after the approval.
The U.S. FDA will be represented at the PDA/PQRI Biosimilars Conference by the following confirmed officials:
- Steven Kozlowski, Supervisory Medical Officer, CDER
- Majorie Shapiro, Biologist, CDER
- Laurie Graham-Eure, Acting Director, Office of Policy for Pharmaceutical Quality, CDER
- Emanuela Lacana, Biologist, CDER
The conference will foster important discussion between industry experts and the U.S. FDA as they address possible solutions and new development strategies for biosimilars. Updates from the U.S. FDA will cover the challenges CMC reviewers face.
PDA is offering all regular registrants a free copy of its newly published book Pharmaceutical Legislation of the European Union, Japan, and the United States of America – An Overview, Second Edition.
PDA Trains Six Auditors from Two Companies in Quality Culture Assessment Tool Pilot
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. The purpose of the pilot is to work with assessors from up to 20 different pharmaceutical companies to refine the assessment tool. The assessment tool is intended to help companies advance their overall quality culture maturity by identifying attributes that are strengths as well as others that are ready for improvement.
"PDA is developing this tool for assessing quality culture maturity within a manufacturing site so that companies can perform internal assessments of their own operations as well as audits of their suppliers and contract manufacturers," said PDA President Richard Johnson. "The pilot is an important step in developing the Quality Culture Assessment Tool to ensure that it is optimized for wider industry use."
During the pilot, the task force developing the tool will be assessing:
- Reproducibility—is the tool objective and verifiable?
- Differentiability—can the tool differentiate sites?
- User-friendliness
- Training effectiveness
Using the tool, assessors will look at various aspects of a manufacturing site to determine how mature the quality culture is. These attributes of quality culture include: leadership commitment, communication & collaboration, employee ownership, continuous improvement, and technical excellence.
Complementing the tool is a survey that companies will use to gather broad input on quality culture behaviors. PDA will conduct an analysis of the maturity attribute data collected by the assessors and behavior data from the surveys at each site to look for correlations similar to what was found in the PDA Quality Culture Maturity Survey of 2015 (an analysis of which was published in the PDA Journal of Pharmaceutical Science and Technology).Each participating site will receive a copy of the analysis of their individual results.
PDA’s task force already submitted comments on the U.S. FDA’s Draft Guidance for Industry: Request for Quality Metrics, published Points to Consider: Pharmaceutical Quality Metrics, and conducted an industrywide survey on quality culture.
Two PDA Leaders Recognized as Most Influential People in Drug Development and Manufacture in 2016
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."
Van Trieste appears on the list at number thirteen and Agalloco at twenty one, keeping august company with the likes of pharmaceutical CEO’s, university professors and renowned researchers, among whom are four Nobel Prize winners.
Van Trieste, who is Sr. VP of Quality at Amgen, was praised for his "quality leadership in biologics" and his record for "advancing quality assurance and helping to ensure a more reliable supply of high-quality medicines." About Agalloco, the publication noted his affiliation with PDA and his prolific writings on the topics of sterilization, aseptic processing and process validation.
The complete list is available at The Medicine Maker.
PDA Receives First Johnson & Johnson Kilmer Award for Contributions to Sterility Assurance Science
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.
Richard Johnson, President of PDA, accepted this award on behalf of the association, with these words:
"Thank you for this honor. PDA is celebrating our 70th anniversary of Connecting People, Science & Regulation. Over this period, products that our members have produced have impacted the lives of hundreds of billions of patients all over the world."
"I am humbled when I think about the leaders upon whose shoulders we stand: [Frederick] Carleton, [Gordon] Personeus, [Frederick] Simon, [Irving] Pflug, and more recent leaders like [James] Akers and [James] Agalloco, [Theodore] Meltzer and [Russell] Madsen, and current contributors like [Maik] Jornitz, [Harold] Baseman, [Martin] Van Trieste, [Michael] Sadowski and [Gabriele] Gori, and the many others who have contributed to this legacy. On their behalf, I am proud to accept this honor."
Johnson & Johnson brought back the landmark Kilmer Conference on sterility assurance and sterilization this May after a 13 year hiatus. Johnson & Johnson hosted eight Kilmer Conferences between 1976-2003 for invited sterility assurance professionals from industry, academia and regulatory authorities. Kilmer Conferences take their name from Fred Kilmer, who was a pioneer in the pharmaceutical industry and director of Johnson & Johnson’s scientific laboratory from 1889-1934.
PDA’s Leadership Challenges Next Generation of Parenteral Manufacturers to be Innovative
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. PDA’s volunteer leadership has led the pharmaceutical and biopharmaceutical industry in innovating manufacturing and control for sterile production and filling operations.
The workshop is the first in a series of four that PDA is sponsoring in 2016 to generate information on current practices in aseptic operations in anticipation of commenting on the European Medicines Agency’s revision to its GMP guidance for sterile drug products, Annex 1.
“Aseptic processing really hasn’t materially changed all that much in 38 years,” observed PDA Immediate-Past-Chair Hal Baseman (ValSource) during his opening remarks. “I really would like to see you, a young group of people moving this industry forward.”
The goal of the workshop series is to generate information on current best practices via breakout discussions and a survey that will be taken at each location.
Baseman was followed on the podium by a number of experts who discussed various aspects of good aseptic processing practices and PDA’s 2015 Points to Consider for Aseptic Processing. Headlining these was Thomas Arista, a U.S. FDA national expert investigator in pharmaceutical and biotechnology, who provided a regulatory perspective on the topic.
The next two-day workshop takes place in Berlin, May 31-June 1.
PDA Launches Pharmaceutical Manufacturing Data Integrity Webpage
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. These work products will be catalogued on a new PDA Data Integrity web page at: www.pda.org/dataintegrity.
A data integrity program is a significant component of a company's Quality System, providing foundational assurance that the data used to demonstrate a company's products are safe and effective for their intended use. Data integrity is a major concern of Health Authorities worldwide. Although not a new issue, numerous recent Health Authority enforcement actions have focused attention on data integrity.
PDA is developing a comprehensive set of tools for industry that includes a recently published “Code of Conduct,” a series of workshops, a book with practical advice on how to prevent or rectify data integrity breaches and technical reports. As each new tool is available, it will be posted to the newly launched Data Integrity web page.
2016 PDA Data Integrity Workshops
These workshops will include a blend of presentations from regulatory and industry experts, case studies and round table discussions. The schedule of workshops:
| April 19-20 | Millennium Gloucester Hotel | London, UK |
| September 14-15 | Renaissance Washington, DC Hotel | Washington, DC |
| November 8-9 | Titanic Chaussee Berlin | Berlin, Germany |
| December 7-8 | Manchester Grand Hyatt | San Diego, CA |
“Code of Conduct for Data Integrity”
The Elements of a Code of Conduct for Data Integrity was developed by a team with expertise in the fields of quality, regulatory affairs, auditing and manufacturing and reviewed by attorneys specializing in food, drug and labor law. It is written for easy adoption by companies without the need for extensive rewriting of the document. It is available for free at: www.pda.org/codeofconduct.
Parenteral Drug Association Publishes First-of-its-Kind Comparison of Sterile Processing GMPs
Electronic document includes link to a customizable spreadsheet
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. The document compares regulatory guidance documents issued by the U.S. FDA, the EU, the Pharmaceutical Inspection Convention/Scheme and the World Health Organization.
PDA’s Global Sterile Task Force, comprised of experts from leading pharmaceutical companies, carefully and thoroughly pored over each sentence of these guidances and developed an extensive comparison of each element. The team then conducted an extensive analysis of the commonalities and differences in the four documents.
"The task force has done a great service for industry by producing this first-of-its kind document, which was reviewed and approved by PDA’s Regulatory Affairs and Quality Advisory Board and Board of Directors," said PDA President Richard Johnson. "The analysis and comparison table are easy-to-use references for companies that need to adhere to the four regulatory documents. The spreadsheet is a tool which allows companies to do their own assessment of their status for each element."
Global Sterile Manufacturing Regulatory Guidance Comparison – With link to Comparison Spreadsheet is available to PDA members and nonmembers at the PDA Bookstore: https://store.pda.org/ProductCatalog/Product.aspx?ID=3085.
The publication includes a link to the Microsoft Excel® spreadsheet, which can be downloaded at no additional cost.
PDA Introduces Newly Elected Executive Committee and Board Members
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. PDA members voted for new members to the Executive Committee and for directors this past fall.
The Chair-Elect is Rebecca Devine, a regulatory consultant and former official with the U.S. FDA. Rebecca will serve for two years as the Chair-Elect before becoming Chair in 2018. Current Chair-Elect Martin VanTrieste, Amgen, Inc., becomes the Chair for 2016 and 2017, and current Chair Hal Baseman, ValSource, will serve two additional years on the Executive Committee as Immediate Past Chair.
Michael Sadowski , Baxter Healthcare, was elected Treasurer, and Jette Christensen, Novo Nordisk A/S was elected Secretary. Both will serve two years in these roles.
Rejoining the Board of Directors for a second consecutive three-year term is Stephan Roenninger, Amgen.
Joining the Board of Directors for a three-year term are:
- Anil Sawant, Merck & Co., Inc.
- Susan Schniepp, Regulatory Compliance Associates, Inc.
- Melissa Seymour, Biogen
PDA also thanks Board members whose terms of service have concluded:
- Anders Vinther, Sanofi Pasteur (outgoing Immediate Past Chair)
- Gabriele Gori, GSK Vaccines
- Lisa Skeens, Pfizer
- Ian Elvins, Elvins & Associates
PDA’s Bob Dana to Retire; Craig Elliott to Lead PDA Education starting in 2016
Bethesda, Md., November 18, 2015 – The Parenteral Drug Association (PDA) has announced a change in leadership for its education programs.
Bob Dana, Sr. VP, Education has announced that he will retire at the end of 2015. Bob has been a long-term contributor to PDA in many ways, starting as a member, volunteer, and Board member, and, for the past ten years, as an employee—first as VP of Quality and Regulatory Affairs, and more recently as Sr. VP, Education. His commitment to PDA has been unwavering. Bob had over 30 years’ experience with industry prior to joining the staff. PDA wishes Bob all the best as he transitions to this new phase of his life.
Craig Elliott, Sr. VP, Finance/CFO, will assume the Sr. Vice President, Education role at the beginning of 2016. Craig has been at PDA more than six years in the CFO capacity, and this new challenge will give Craig the opportunity to expand his contributions to our organization, and to utilize his background in pharmaceutical manufacturing in a new way. Craig has a Bachelor’s degree in Microbiology and a Master’s in Business Administration. Prior to his 6 years with PDA, his career also includes 5 years at Merck & Co. in the QC & QA functions and 5 years with Genentech supporting the Operations, Quality & Regulatory Affairs functions.
PDA is in the process of identifying a candidate for the Finance position.
The Education activity is a key component of PDA’s future strategy, and our commitment to continue to invest and expand this function is clear. Craig and Bob began working together on this transition in September. PDA looks forward to Craig’s continued contributions to the organization in this new role.
2015 PDA Quality Metrics Conference Offers Latest Details on FDA’s Metrics Gathering Program
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. The U.S. FDA is co-chairing the event. Agency representatives will use the forum to provide updates on its pharmaceutical quality metrics program that launched following the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012.
"We find it very important to offer this forum on the quality metrics program so quality and other professionals within the pharmaceutical business can interact directly with FDA representatives," said PDA President Richard Johnson. "Just the very first session of the meeting has four presentation by FDA and concludes with an ample Q&A session with a panelist of five Agency officials."
Overall, seven FDA speakers will take the podium during the event. The British MHRA’s vision of quality metrics in Europe will be presented by Gerald Heddell, the Director of the Inspection Enforcement & Standards Division. The rest of the agenda is dedicated to high-level presentations from industry representatives.
PDA has been an active contributor to the metrics program since FDA reached out for public input into the program. A PDA task force of industry experts has published two Points to Consider documents on quality metrics and a survey on quality culture. The team also helped plan the three workshops to date. In August, PDA’s Johnson spoke at a public forum on the just-released FDA draft guidance on metrics, and the task force is currently finalizing PDA’s official comments on the document.
103 Vendors Displaying Solutions at 2015 PDA Universe of Pre-filled Syringes Conference
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.
“The Universe of Pre-filled Syringes and Injection Devices covers all aspects of advancements in drug delivery for injectables,” said PDA President Richard Johnson. “The conference provides the latest information on new materials, drugs and application systems in the interest of public health and to the benefit of patients and health care providers.”
The 2015 meeting sessions will address recent trends in development and manufacturing of pre-filled syringes, including patients’ and the regulators’ views, as well as regulatory and compliance trends for combination products/drug devices. The conference agenda is designed to encourage discussion amongst the scientific community, regulators and industry professionals.
PDA Presents Largest Exhibit of Commercial Inspection Hardware at ’15 Visual Inspection Forum
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.
Exhibitors showing off their latest inspection systems include forum sponsors Bosch Inspection Technology, Biothermal, and Kyoto Automation. Attendees will receive the latest information in two full days of information-packed sessions, and then have a chance to see the latest visual inspection technologies that are critical to this important quality control function for sterile drug products.
“PDA has a long history of advancing the science of particulate visible inspection,” said PDA President Richard Johnson. “This Forum is just one of the many ways our volunteers contribute to this field.”
The Forum includes speakers representing industry and the U.S. FDA centers for drugs and biologics (CDER/CBER). Eli Lilly, Merck, Genentech, and Sandoz are just a sampling of the companies sharing their knowledge and expertise at the event.
A sold out PDA Education course, “An Introduction to Visual Inspection,” follows the forum.
PDA’s Annual Global Conference on Pharmaceutical Microbiology Celebrates 10 Years
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.
This year’s conference, themed "Promoting Excellence: Past Lessons, Present Solutions and Future Visions," takes place in the Bethesda North Marriott Hotel and Conference Center, Bethesda, MD, Oct. 19-21. It is followed by a course series at the same venue, October 22-23.
The conference features two discussions about the science behind the fight against the Ebola virus and the global regulatory cooperative efforts to bring vaccines and treatments to the marketplace faster. Dr. Michael Kurilla of the National Institute of Allergy and Infectious Disease, a part of the National Institutes of Health, will discuss the scientific breakthroughs. Dr. Lucian Borio of the U.S. FDA Office of Counterterrorism and Emerging Threats will highlight the global collaboration.
PDA will recognize all of the planning committee members who participated in developing this conference each year since 2005.
"PDA is grateful to our member volunteers who have made the annual global microbiology conference one of the association’s signature events," said PDA President Richard Johnson. "Microbiology is a critical science behind the manufacture of safe and effective sterile drug products, which is one of the primary fields of work for the majority of the Association’s 10,000 members."
Over the years, the conference has added popular sessions like "Urban Myths" and "Emerging Leaders," both of which return in 2015.
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 President Richard Johnson addressed the U.S. FDA on behalf of the Association and its Quality Metrics Task Force of volunteers. Among its recommendations, PDA believes a company's quality culture is critical, but cannot be easily assessed through metrics. Trending of metrics within a site/company/products is preferable to direct comparison between sites/companies/products. FDA might consider adding a "right first time" metric in the future. PDA will include all the recommendations covered by Johnson and other recommendations, in its written comments on the draft guidance, which are due to the Agency in September.
"We are pleased that the U.S. FDA continues to offer extensive opportunities for industry to participate in this ongoing endeavor to develop a quality metrics program," said Richard Johnson after his remarks. "PDA has led a number of key initiatives in this area, including working with the U.S. FDA to sponsor several information-gathering workshops, conducting a comprehensive industry survey on quality culture in 2014, and publishing a Points to Consider on Pharmaceutical Quality Metrics last year."
PDA will publish the results of the 2014 quality culture survey in September and is holding a third Pharmaceutical Quality Metrics Conference November 9-10 in Bethesda, 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.
India hosts a rapidly growing active pharmaceutical ingredient (API) industry, which is growing at 10% annually and now accounts for approximately 20% of the global marketplace, which is valued at over $100 billion.
API producers must meet GMP requirements, and the ICH Q7 guideline is the most widely accepted standard globally. PDA has a long history of educating the industry globally on this guidance, and by teaming with PIC/S, will deliver two-day courses in Hyderbad and Ahmedabad that cover how the document has been interpreted and enforced.
The 2015 PDA PIC/S Training Course includes members of the original ICH Expert Work Group (EWG) and current Implementation Working Group (IWG) who are asked to develop Q&As to facilitate implementation.
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.
"This latest accreditation further demonstrates the value and quality of PDA's professional education offerings," said PDA President Richard Johnson. "Our lecture courses and hands-on professional training at the Training and Research Institute in Bethesda are taught by leading experts in the pharmaceutical industry."
PDA Education already is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. In 2014, 31 PDA Education courses were listed with the U.S. General Services Administration (GSA).
For more on PDA Education, Where Excellence Begins, go to www.pda.org.