The Southern California PDA is Proud to Present the 7th Annual Industry Summit and Exhibitor Showcase.
The Nixon Library
Yorba Linda, CA
- Networking, Presentations, and Exhibits
- FDA Speaker Confirmed!
- Technical Session - Combination Products
- Red, White, and Blue Theme: "Show your Colors" (participate in Best-Dressed contest)
- Gourmet Buffet, Wine and Beer, Cash Bar
- Raffle Prizes
- Transportation will be provided from San Diego, Los Angeles, and Thousand Oaks
Who Should Attend
Professionals from the life science, drug, and cosmetic industries involved with development, manufacture, testing, quality control, and distribution of regulation products.
Subject to change
4:00PM-5:00PM - Networking
4:30PM-7:30PM - Appetizers, Beer & Wine Tasting Start
4:45PM-5:00PM - Opening remarks
5:00PM-5:45PM - Technical Session - Combination Products
5:45PM-6:15PM - Networking & Vendor Announcements
6:15PM-7:00PM - FDA Keynote Presentation - Investigations and Poor Quality Systems: Top-Down as a Root Cause
7:00PM-7:30PM - Networking & Vendor Announcements
7:30PM-8:00PM - Buffet with Dessert, Coffee & Tea
8:00PM-8:45PM - Networking-Speed Networking
8:45PM-9:00PM - Raffle & Closing Remarks
About the Speakers
Philip Krieter, Compliance Officer, FDA/CDER
Phil conducts compliance activities as an officer with the FDA CDER Office of Manufacturing Quality (OMQ) for both foreign and domestic pharmaceutical manufacturing sites. Prior to becoming a compliance officer, he led inspections of pharmaceutical firms for compliance with the Food, Drug, and Cosmetic Act and its implementing regulations as an investigator within the FDA ORA New England District Office. Phil came to the FDA from a position in health system pharmacy, where he worked in pharmacy robotics since an intern in college. He holds an undergraduate degree in biology and graduate degrees in Regulatory Affairs and Biotechnology and Management from Harvard and Northeastern universities. In his spare time, Phil enjoys working with various fitness communities and attending vintage car shows.
Nayan Patel, Regulatory Affairs Manager, Devices, Amgen
Nayan manages global regulatory submissions for electro-mechanical combination products at Amgen. Prior to Amgen, he was a pre-market reviewer in the Office of Device Evaluation in CDRH at the FDA where he primarily reviewed anesthesia and respiratory devices and combination products. He holds an undergraduate degree in Bioengineering from the University of Washington and a Master's degree in Biomedical Engineering from the University of California, Irvine. In his spare time, Nayan enjoys playing soccer and exploring new restaurants.
Attendee registration includes 1 attendee ticket, speaker presentations, event bag, parking, appetizers, buffet, dessert, beer & wine tasting, exhibitor showcase, raffle prize entry, discount on ticket to tour RNL.
(before Feb 21)
|On the Day of the Event
|PDA Member Price
|**Government Employees and Students
**Government or Student Nonmembers email Katie Ruiz at PDA for offline registration discount.
Cancellations: Receive a full refund on cancellations received on or before February 14th. 50% refunds between Feb 15-21. No refunds after Feb 21. No substitutions, please.
Exhibitors, Sponsorships and Exhibitor Donations
Visit the following exhibitors at the event:
- BioScience International
- Ellab, Inc.
- Nitto Avecia Pharma
- Pace Analytical Life Sciences
- STERIS Life Sciences
- Technical Safety Services
- Veltek Associates, Inc.
- ...and more to come!
For more information contact: Tita Tavares, email@example.com, Ph. No. (714) 724-4221 or Francis Cappello, firstname.lastname@example.org, Ph. No. (714) 930-3996
Support for Elite Veterans Initiative
SoCal PDA Chapter and Participating Vendors will be making a donation to Elite Veterans Initiative of Irvine CA, a non-profit group that helps and supports our nations Veterans. For more information about Elite Veterans Initiative go to www.eliteveteransinitiative.com.
About Parenteral Drug Association (PDA): PDA is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA's mission is to develop scientifically sound, practical, technical information, and resources to advance science and regulation for the pharmaceutical and biopharmaceutical industry through the expertise of global membership (www.pda.org).
For immediate assistance please contact: Randy George, email@example.com