PDA Metro Chapter: Process Validation

What are we STILL getting wrong in 2025?

13 Nov 2025
The Olde Mill Inn
Basking Ridge, NJ

Educational Sessions, Networking Opportunities

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Join the PDA Metro Chapter for an evening of networking, knowledge-sharing, and industry collaboration. This year's focus is on Quality for Process Validation - a critical area as process validation continue to play an increasingly vital role in the pharmaceutical and biopharmaceutical landscape. 

Participants will enjoy time with vendors and peers over food and drinks, followed by a seminar and discussion exploring how process validation can strengthen quality systems, meet evolving regulatory expectations, and partner effectively with sponsors to ensure patient

Group Registration:

Special discount for same company multiple pre-registration (three or more attendees) $10 off each additional attendee. Please contact us.

The most recent update to the FDA Lifecycle Process Validation guidance was issued nearly 15 years ago.  Many advances in have been made in executing Process Validation since then but there are many companies who are still getting it wrong (as evidenced by multiple 483 observations and Warning Letters on this topic).  This talk will summarize and compare global Health Authority feedback on the topic of Process Validation from both 2018 and from the past two years.

  • Shawn Gould

    Johnson & Johnson’s

    Director of Compliance

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Agenda

Discover What's Happening Each Day
Thu 13 Nov
Thursday, 13 November

5:15 pm - 6:15 pm Registration Begins (Cash Bar, Food)

6:15 pm - 7:00 pm Dinner

7:00 pm - 8:30 pm Welcome, Seminar, Q&A and Closing Remarks

Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Grain House

225 Route 202
Basking Ridge, NJ 07920

Registration

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Standard Registration

Member Price

$99

Non-Member

$99

See Qualifying Criteria for Member Types.

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Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Metro Chapter: Process Validation! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

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Boost your brand and visibility by becoming an exhibitor at the PDA Metro Chapter: Process Validation! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

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