UPCOMING EVENTS
PDA focus on Science & Patients in a Changed Regulatory & Re-Configured Supply Chain World
Thursday, April 23, 2026
TIME:
5:00-6:00: Networking and Cash Bar, Vendors Displays in the Main Foyer
6:00-7:30: Dinner Buffet
7:30-9:00: Presentation
Location:
Desmond Hotel and Convention Center, Malvern, PA 19355
Presenter: Anil Sawant, PhD.
Senior Vice President, Global Quality Transformation, Merck & Co
Immediate Past Chair, Board of Directors, Parenteral Drug Association
BIO OF PRESENTER:
Anil Sawant, PhD, has over 35 years of experience in the biopharmaceutical industry. He has expertise in Quality & Compliance, Pharmaceutical Microbiology, Business Ethics, Auditing, and R&D functions. Anil has worked on various dosage forms, drugs, biologics, vaccines, and medical devices. He was involved in the development & commercialization of the first antibody-drug
conjugate and the first photoactive drug. Anil has been a PDA Member and volunteer for over 35 years. He has served on PDA RAQAB, Board of Directors, and is currently the Immediate Past Chair. Anil has co-authored numerous PDA Technical Reports, White Papers, and original research
papers in peer-reviewed journals, primarily on topics related to infectious diseases, antimicrobials, and yeast physiology. He Chaired the PDA Data Integrity Task Force, and the PDA COVID Task Force. Anil has member of the National Academy of Science, Engineering, and Medicine program committee on US-India Bio Economy and has been an invited speaker at the WHO World Local Production Forum (WLPF) in The Hague (2023) and in Abu Dhabi (2025). He holds a B.Sc. Honors and a M.Sc. Honors in Microbiology & Biochemistry from Panjab University, India, and a PhD in
Microbial and Biochemical Sciences from Georgia State University, Atlanta. Anil is a board member of the non-profit Mind Your Brain Foundation and has served on the Board of Directors of the GSU Alumni Association. He is a recipient of the GSU Distinguished Alumni Award and PDA Distinguished Service Award.
Ticket Price: $80.00 (Attendee)
Register to this Event:Networking Night
May 2026
Details coming soon.
Location:
Top Golf, King of Prussia, PA
Vendor Night
Thursday, October 15, 2026
Title:
Regulatory Intelligence, FDA insights, and/or advanced use of AI beyond basic “copilot” functionality.
Speaker:
George Kwiecinski and Peter Berzin, President, Global Key Solutions
Location:
Desmond Hotel, Malvern PA
Ticket Price: $80.00
Register to this Event:PAST EVENTS
ISPE DVC, PDA DVC, & ASHRAE Leigh Valley and Philadelphia Joint Ugly Sweater Holiday Social
Break out your most outrageous holiday sweater and join us for an evening of networking, appetizers, and festive cheer!
Thursday, December 18, 2025
Time: 5:00 PM – 7:00 PM
Location: Well Crafted Brewery, 310 Madison St, Lansdale, PA 19446
Cost: $20 per person
About This Event: The International Society of Pharmaceutical Engineers Delaware Valley Chapter (ISPE DVC), American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Leigh Valley and Philadelphia Chapters, and Parenteral Drug Association (PDA) Delaware Valley Chapter are pleased to collaborate in co-hosting a professional networking reception this holiday season.
This is a fantastic opportunity to expand your professional network, exchange valuable industry insights, and foster connections with peers and potential collaborators from the larger life sciences community. Whether you're a seasoned professional or new to the field, enjoy good company, great conversation, and laugh over the most creative (or hideous) holiday sweater!
What's Included:
Your $20 ticket covers everything for the evening:
- Appetizers: Pretzel Bites with Beer Cheese, Hummus and Pita, Hot Honey Flatbread, and Margarita Flatbread.
- Beverage Options (One Drink Ticket Included): 16oz Draft Beer, Hard Seltzer, and Non-Alcoholic Beverages.
Bonus: Comedy Open Mic Night:
At the event's conclusion, the venue will host a public Comedy Open Mic beginning at 7:00 PM. It's a fun, casual way to extend the evening. Feel like getting on stage? Everyone's welcome to take the mic for 5 minutes and share some laughs.
Using AI to Aid Drug and Device Development and Manage Regulatory Risks & Vendor Night
Thursday, October 16, 2025
PRESENTER(S): Doug Mead, President & Principal, CP Pathways, LLC
SPECIAL FEATURE: The evening will start with our Annual Vendor Night Extravaganza which will feature 40 vendors displays in the Foyer and Main Room of the Desmond Hotel. Included will be food stations, beverages, a cash bar and 40 vendor raffles. The presentation will be conducted in the Amphitheater of the Desmond Hotel (3rd Floor of Conference Center). More Information to be posted soon.
SUMMARY OF PRESENTATION:
Generative AI (GenAI) search tools can be a powerful resource for researching
regulatory expectations. The FDA’s Drugs@FDA database contains detailed reviewer memos, correspondence, and labeling information for all drugs approved by CDER. These documents offer valuable insights into the data and content companies should submit—and what the FDA ultimately requires for approval. Similarly, the EMA’s EPAR database provides summaries of the assessments conducted for medicinal product approvals. Both resources include specific information related to drug CMC and quality expectations, and requirements for any drug delivery devices. By leveraging these databases with AI-enabled searches, developers and regulatory teams can identify regulatory trends, align submission strategies with agency expectations, and proactively address potential regulatory risks. Examples of AI-assisted search results and a brief demonstration will be presented.
BIO OF PRESENTER:
Doug Mead was formerly Senior Director, Regulatory Affairs, Combination Products and
Medical Devices, at Johnson & Johnson (Janssen) and led that function for over 13 years. As a combination product consultant for the last five years, he has assisted multiple combination product companies with novel delivery device development strategies and regulatory submissions. Operating as CP Pathways LLC, he has supported prefilled syringes, autoinjectors, nasal sprays, ambulatory pumps, nebulizers, and specialized cannulas for drug delivery and their regulatory submissions. Recently, he became a Co-founder of Rhizome AI, which has developed an AI software tool for researching FDA databases and other databases for device development and regulatory insights.
TIME:
5:00 – 7:15: Networking, food stations, beverages, cash bar, vendor raffles in Exhibit Hall
7:30 – 8:45: Presentation and Q&A
LOCATION:
Desmond Hotel and Convention Center, Malvern, PA 19355
TICKET PRICE:
$80.00 (Attendee)
$800.00 (Company Booth) (Please reserve ASAP will sell out quickly!)
How to Navigate Annex I with New Sterilization Technologies & Case Studies
Thursday, September 18th, 2025
PRESENTER(S):
Darren Beckett – Senior Training and R&D Manager – Fedegari
SUMMARY OF PRESENTATION:
This presentation will highlight two in-depth case studies focused on the practical impact of recent updates to EU GMP Annex 1 on sterile manufacturing and process control.
- Case Study 1: Integrated Solution for Sterile Filling of Antibiotic Powder in Alu Kegs
This case study examines how the revised Annex 1 requirements—particularly around the Contamination Control Strategy (CCS)—have influenced the design and implementation of integrated process solutions. The discussion will explore key considerations for adapting processes in line with updated regulatory requirements. - Case Study 2: Parametric Release in Sterilization Processes
This case study addresses the effect of Annex 1 revisions on sterility assurance and parametric release strategies. The session will outline how updated guidance has shaped process control in sterilization.
BIO OF PRESENTER(S):
Darren Beckett has over 25 years of hands-on industrial experience in the Biotech and Pharmaceutical industry, focusing on qualification, validation and process development of moist and dry heat sterilizers and critical utility systems. He is an established SME for these processes, primarily focusing on Fedegari equipment. Darren has delivered training courses on industrial sterilization and autoclave C&Q across the world over the last 15 years and currently leads the Fedegari Technology Center in the US, responsible for technical training and process consultancy focused on sterilization, decontamination, washing and associated aseptic processes. Darren is a lecturer and committee member for various association (PDA, ISPE) and also lectures on Masters degree programs at universities.
TIME:
5:00PM - 8:00PM
INCLUDED WITH REGISTRATION:
Catering, Social hour, Presentation, Equipment Overview
LOCATION:
Fedegari's Technology Center
1228 Bethlehem Pike, Sellersvile PA 18960
TICKET PRICE: $25.00
Compliance in GMP Environments: What it Means to be Trained & Qualified in Pharmaceutical Biotech, Featuring the Delaware Valley Science Fair Finalists (Grades 8-12).
Thursday, June 05, 2025
PRESENTERS: Cheryl Custard, Director US Quality Systems, Adaptimmue
SPECIAL FEATURE: The PDA Delaware Valley Science Fair has been supported by the Delaware Valley Chapter of PDA for over 30 years. As judged by the PDA Planning Committee, the finalists and their families will all be in attendance with their displays in the foyer and relate to the entire assembly a summary of their science project and results. These amazing kids are the next generation of scientists in our world. Come support their efforts.
PRESENTATION TITLE: Compliance in GMP Environments: What it Means to be Trained & Qualified in Pharmaceutical Biotech
SUMMARY OF PRESENTATION: There can be many interpretations of what regulators want when they require trained and qualified operators perform roles within a GMP regulated environment. This presentation will delve into what is expected of Biotech with regards to training & qualification regulations and how to ensure companies are meeting these regulatory requirements.
TIME:
5:00-6:00: Networking and Cash Bar – PDA Delaware Valley Student Science Fair Displays
6:00-8:00: Dinner in Main Ballroom
8:00-9:15: Presentation
LOCATION:
Desmond Hotel and Convention Center, Malvern, PA 19355
TICKET PRICE: $80.00
A Lifecycle Approach to Particle Control in Cellular ATMPs
Thursday, April 24, 2025
PRESENTERS: Stephanie Martin and Shannon McMorris from Adaptimmune
PRESENTATION TITLE: A Lifecycle Approach to Particle Control in Cellular ATMPs
SUMMARY OF PRESENTATION: Particle control in cellular ATMPs (Advanced Therapy Medicinal Products) presents a unique challenge to the industry. Part 1 of this presentation will cover a lifecycle approach to understanding, identifying, and controlling particles, while integrating regulatory requirements and quality considerations. Part 2 will dive into the application of the lifecycle, detailing the implementation of a Visual Inspection Program for an autologous cell therapy.
TIME:
5:00-6:00: Networking and Cash Bar, Vendors Displays in the Main Foyer
6:00-7:30: Dinner Buffet
7:30-9:00: Presentation
LOCATION:
Desmond Hotel and Convention Center, Malvern, PA 19355
TICKET PRICE: $80.00
To stay up to date on where we have been, visit our Past Events page
BECOME A SPONSOR
Gain access to over 2,000 industry professionals by becoming a sponsor of PDA Delaware Valley!
EVENTS
Check out our Events Calendar! With events ranging from breakfast symposiums to vendor nights to science fairs, we cater to the entire industry!
CONTACT US
For more information on chapter activities, please send your query to contact@pdadelval.org