The Southern California PDA is Proud to Present the 7th Annual Industry Summit and Exhibitor Showcase.
The Nixon Library
Yorba Linda, CA
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 - Registration Opens, Networking and Exhibits
4:15PM - Appetizers, Beer & Wine Tasting Start
4:45PM-5:00PM - Opening remarks
5:00PM-6:00PM - Technical Session - Combination Products (two speaker presentations)
6:00PM-6:30PM - Networking & Vendor Announcements
6:30PM-7:00PM - FDA Keynote Presentation - Investigations and Poor Quality Systems: Top-Down as a Root Cause
7:00PM-7:30PM - Networking & Vendor Announcements
7:00PM-8:00PM - Dinner Buffet with Dessert, Coffee & Tea and Donation Announcement
8:00PM-8:45PM - Networking-Speed Networking
8:45PM-9:00PM - Raffle & Closing Remarks
Investigations and Poor Quality Systems: Top-Down as a Root Cause - Philip Kreiter, FDA
FDA presentation abstract coming soon.
Regulatory Aspects of Biologic-Device Combination Products (EU & US) - Nayan Patel, Amgen
The presentation will cover:
definitions and filing types for biologic-device combination
products; design controls for combination products; filing strategy for combination products
Registration Considerations for Cross-labeled Combination Products - Niedre Heckman, Shire
One definition of a combination product, as outlined in 21 CFR 3.2(e), includes components which are provided separately but which are labeled specifically for use together. This presentation is a discussion of considerations when registering combination products which are cross-labeled.
About the Speakers
Philip Kreiter, 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.
Niedre Heckman, Associate Director, Global Regulatory Affairs, Shire
Niedre has worked in Regulatory Affairs supporting
medical devices as standalone products and as combination products with drugs and biologics for nearly ten years. Currently, Niedre works at Shire and previously, she worked for Baxter Healthcare Corporation. Prior to this, Niedre worked for 3M Drug Delivery Systems supporting pharmaceutical Quality. She has received numerous awards and commendations, including one of each from FDA for contributions to Regulatory Science and Quality. Niedre holds an MS in Chemistry from UCI, an MPH from UCLA, and certifications: ASQ-CQA and RAC.
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.
Trouble registering online? Download the attendee registration form.
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
Exhibitor and sponsorhip packagages are now available. Download the registration form now to submit payment by credit card or payment by check.
Reserve your table here!
This is on a first come first serve basis. Payment must be received within 24-hours of table request, otherwise your desired tables will be released. Table requests need to match your registration form as well.
Visit the following exhibitors at the event:
- Atara Biotherapeutics, Inc.
- Azbil BioVigilant
- Beckman Coulter Life Sciences
- Bioscience International, Inc.
- Bioserv Corporation
- Boston Analytical
- Contec, Inc.
- Ellab, Inc.
- Eurofins Lancaster Laboratories
- Extract Technologies
- Gateway Analytical
- Gerflor USA
- GXP CDMO Biopharma, LLC
- Isolation Systems, Inc.
- Lyophilization Technology, Inc
- Micronova Manufacturing, Inc.
- Nitto Avecia Pharma Services, Inc.
- Northeastern University
- Novatek International
- Pace Analytical Life Sciences, LLC
- Particle Measuring Systems
- PSC Biotech and PSC Partners Pharm Equipment
- Quadrants Scientific, Inc.
- Skan US, Inc.
- SQA Services, Inc.
- STERIS Life Sciences
- Technical Safety Services
- Vanrx Pharmasystems, Inc.
- Veltek Associates, Inc.
- Wilco Precision Tester USA LLC
- ...and more to come!
For more information contact: Tita Tavares, firstname.lastname@example.org, Ph. No. (714) 724-4221 or Randy George, email@example.com, Ph. No. (949) 932-1802
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, firstname.lastname@example.org