- Sarah Barkow, PhD – Senior Policy Advisor, Guidance & Policy Staff, Office of Manufacturing Quality, OC, CDER, FDA Current position: Senior Director, Proactive Compliance & Innovation, AstraZeneca
- Tamika Cathey – Consumer Safety Officer, OII (former ORA), FDA Current position: Principal Technical Lead for Life Science Division, NSF
- Alonza Cruse – Director, Office of Human & Animal Drug Inspectorate, OII, FDA (Retired)
- Maya Davis, PhD – Senior Consumer Safety Officer, Office of Quality Surveillance, CDER, FDA Current position: Senior Vice President, Regulatory Compliance, Eliquent Life Sciences
- David Doleski – Deputy Director (Acting), Office of Process & Facilities (now Office of Pharmaceutical Manufacturing Assessment), Office of Pharmaceutical Quality, CDER, FDA Current position: Compliance Head for Vaccines, Sanofi
- Lynne Ensor, PhD – Deputy Office Director (Acting), Office of Process & Facilities (now Office of Pharmaceutical Manufacturing Assessment), Office of Pharmaceutical Quality, CDER, FDA Current position: President/Owner/Regulatory Consultant, Ensor Pharma Biotech Consulting
- Christopher Middendorf – Senior Compliance Policy Advisor, Aseptic Manufacturing & DI SME, Office of Compliance, CDER, FDA Current position: Senior Director, Technical, Pharma & Biotech GxP Compliance, Hogan Lovells LLP
- 5 to 9 registrants from the same company: 10% off the registration price*
- 10 or more registrants from the same company: 15% off the registration price*
- 5 to 9 registrants from the same company: 10% off the registration price*
- 10 or more registrants from the same company: 15% off the registration price*
7 former FDA Regulators confirmed for 30th Annual GMP By The Sea
For 30 years, GMP By The Sea has been widely considered to be the top conference on GMPs in the U.S. The agenda focuses on the latest developments in GMPs presented by an impressive roster of experts. This year will be no different. Our program committee recently met and is currently working to create another focused, informative conference. The agenda will once again deliver top notch speakers, topics and venue.
We already have seven former FDA personnel confirmed to speak. Here is the initial lineup with their last position at FDA:
Current FDA personnel have been invited and invitations are still pending.
The conference brochure will be online in late February, but registration for the conference is open now on Pharma Conference’s secure online server. We’re offering a $350 discount for anyone who registers through February 20, 2026: click here to register.
We also have discounts for concurrent group registrations:
*To receive the group discount, attendees must register on the group registration form and pay concurrently.
For more information on this upcoming conference, contact Pharma Conference.
30th Annual GMP By The Sea Set for August 2026
Pharma Conference Inc has announced the 2026 date for its flagship conference, GMP By The Sea. The 2026 conference, which marks the event’s 30th anniversary, will be held August 17 – 19, 2026, at the beautiful Hyatt Chesapeake Bay Hotel in Cambridge, Maryland.
For 30 years, GMP By The Sea has been widely considered the top conference on GMPs in the U.S. The agenda focuses on the latest developments in GMPs presented by an impressive roster of experts.
“Our program committee met this week and is hard at work putting together another focused, informative conference,” announced J.W. Smith, president of Pharma Conference. Attendees can count on the agenda once again delivering top notch speakers, topics, and venue, Smith said.
Smith went on to say that the 2026 conference will be offered at the same prices as the 2025 conference and has added an “extra early” registration discount that will save attendees who register on or before February 16, 2026, $350. Pharma Conference also offers discounts for concurrent group registrations:
*To receive the group discount, attendees must register on the group registration form and pay concurrently.
FDA representation at the conference is currently under consideration by FDA, and invitations are being sent. Smith said updates will be provided on the Pharma Conference website as speakers are confirmed.
Last year’s attendees had high praise for the conference:
“I had an amazing experience at GMP By The Sea. The subject content is very educational and informative. The hosts were great, and registration team was amazing. All speakers were very knowledgeable on the subject at hand and delivery was very engaging.”
“Hands down best professional conference I have attended. Would love to come back year after year.”
“Love how interactive the workshops are.”
“Fantastic choice of topics. Loved the focus on AI on Day 2.”
GMP By The Sea is the most valuable conference for companies wanting to stay on top of the absolute latest in GMPs to keep their operations running smoothly. The full conference brochure will be online in late February, but registration for the conference is open now on Pharma Conference’s secure online server. Click here to register.
