PDA Capital Area Chapter
Chapter's Region:
Washington, DC / Maryland / Virginia (Northern) / West Virginia
Welcome to the PDA Capital Area chapter website. Here you will find information regarding all chapter activities. We encourage you to stay connected to your local industry community by participating in an upcoming chapter event or forum discussion. Chapter Leaders welcome your questions/comments and look forward to hearing from you.
Chapter Events
Sponsors
PDA Capital Area Chapter welcomes sponsors to participate in upcoming events. We thank all the sponsors who have supported PDA Capital Area events in the past.
Please send all sponsorship inquires to Martin Jenkins, Chapter President.
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About Us
The PDA Capital Area Chapter has its origins dating back to the fall of 1992. It all started with a phone to PDA President Edmund Fry from Rande Leibowitz, who had just moved to Maryland from New England, where he was active in the New England Chapter. When he was informed that no local PDA chapter existed, he asked the simple question, "why not?" Soon Rande found himself with a list of local PDA members and a mission: form the chapter.
Rande got together with a core group of dedicated volunteers and started work on the chapter's first activity: a questionnaire to gauge local interest. Soon we organized our first meeting. In the spring of 1994, Rande Leibowitz was elected first Chapter President, along with Bill Stoedter, Kelly Langan and Sylvia Issacson as President-Elect, Secretary and Treasurer, respectively.
We have been holding three to four meetings a year, consisting of both conventional dinner meetings and site tours of local facilities. We have heard excellent presentations by various speakers including our very first meeting in 1993, where Mike Beatrice (then at FDA) spoke about multi-use facilities and changes in FDA.
There are many people and companies to thank for the success of the Capital Area Chapter. Without them, we wouldn't be able to serve the Washington, D.C. Metro area PDA members with fine local programs and events. Thanks to all and keep up your support!
Past Presidents
- Tita Tavares, Immediate Past President and Chapter Advisor
- Allen L. Burgenson, 2005 - 2009
- Barry A. Friedman, Ph.D. 2004 - 2005
- Robert J. Mello, Ph.D. 2002 - 2004
- Allen L. Burgenson, 1999 - 2002
- William H. Stoedter, 1997- 1999
- Randy Liebowitz, 1995 - 1997
PDA Capital Area Chapter - Dulles Airport/United Airlines Event
Get Involved
We welcome the active participation of PDA members as well as non-members as we chart our course for the future. If you would like more information about ways to get involved with the PDA Capital Area Chapter, please contact Martin Jenkins, Chapter President, martinjenkinspmp@comcast.net.
Capital Area Chapter is looking for volunteers for the following committees:
- Membership Committee
- Publications Committee
- Vendor Show Committee
- Meetings Committee
- Special Events Committee
Recorded Presentation
Webinar: PDA Final Take- By Sharif Tusuubira
Event Date: January 26, 2023
Webinar:Remote Compliance Auditing During the COVID-19 Pandemic
Event Date: July 28, 2020
Webinar: Designing Flexibility into the Full Temperature Range of GMP BioPharma Storage
Event Date: June 26, 2020
Chapter Officers
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Martin JenkinsPresident/Senior Consultant
President
Circle MJ Consulting
Martin Jenkins, PMP has over 25 years of experience leading equipment and facility qualifications, technology development and transfers, as well as leading projects and programs in the pharmaceutical, biotechnology, and life science industries. He is currently the Senior Project Manager for Qualification and Validation at Circle MJ Consulting. Martin is also the President of the Capital Area Chapter of the PDA. Martin’s experiences include working with CGMP products such as API drugs, bulk pharmaceuticals, medical devices, sterile injectables, customized cell culture products, enzymes, amino acids, proteins, chemicals, animal health and agricultural products in the areas of analytical chemistry, molecular biology, microbiology, forensics, veterinary, and entomology. This includes processes such as drug and device manufacturing, cleaning, environmental monitoring, spray drying, packaging, utility qualification, facility commissioning, labelling, product design, laboratory and assay testing.
Martin is well versed in Validation, Quality Initiatives, Quality Assurance and Regulatory Affairs, R&D, Process Analytical Technology, Manufacturing Operations, Commissioning, Remediation, ALCOA+ Documentation Principles, Program Leadership, Project Management, Team Development, Design for Six Sigma, CGDP, Risk Assessment, DMAIC Six Sigma, Lean, Process Analysis, and Lab Management. He is skilled also in leading multi-site level projects with small and large teams.
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Stephanie BrandfordSecretary
Brayearst Validation Consulting
Stephanie is a Carnegie Mellon chemical engineering graduate with a passion for optimization and compliance. Her career began in the chemical industry, where she focused on environmental regulations and leveraged statistical process control to enhance manufacturing processes, driving efficiency and sustainability.
Transitioning to the medical device industry, Stephanie brought these principles into the highly regulated realm of FDA standards. She dedicated herself to ensuring the safety and reliability of life-saving products, earning her Six Sigma Black Belt certification and taking on a leadership role in validation engineering. Over the past decade, she has conducted peer reviews of validation packages, identifying compliance gaps and areas for improvement. In addition, Stephanie has spent 12 years designing and delivering training programs, equipping professionals with expertise in validation and Six Sigma methodologies.
As the founder of Brayearst Validation Consulting, Stephanie leads a company dedicated to implementing Six Sigma methodologies across validation projects, training programs, and spot check services. With a deep understanding of Life Sciences products and processes, Brayearst produces robust validation documentation designed to meet stringent regulatory standards and audit requirements. Stephanie’s work reflects her unwavering commitment to precision, compliance, and advancing industry standards.
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Ben Bhatarrai
Treasurer
Presentations & Resources
- PDA Chapter Council Presentation 11 April 2024
- Minimizing risk in your raw material supply chain
- Process Validation FDAs 2011 Guidance
- Dispelling the Myths of Cleaning Validation
- Combination Products A Regulatory Perspective
- A Response to FDA Perspective on Approaches for Complying with CGMPS During Phase I INDs Draft Guidance for Industry
- Aseptic Processing Risk Assessment The Simplified Akers-Agalloco Method
- Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives
- Remote Compliance Auditing During the COVID-19 Pandemic
- FDA Perspective on Approaches for Complying with CGMPS During Phase I INDs Draft Guidance for Industry
- Risk Assessment Principles for the Product Quality Initiatives
- Its a Bird It’s a Plane No Wait It is Finally Multi-Center Current Thinking on Parametric Release of Drug Products Terminally Sterilized by Moist Heat
Chapter Resources
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