PDA Southern California Chapter 7th Annual Industry Summit and Exhibitor Showcase
Yorba Linda, CA
The Southern California PDA is Proud to Present the 7th Annual Industry Summit and Exhibitor Showcase.
- 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.
Contact: Tita Tavares
Contact Phone: (714) 724-4221
Contact Email: email@example.com
The Nixon Library
Yorba Linda, CA