Compliance of the Dietary Supplement Industry

Event at FDA Los Angeles District Office, Irvine CA on Thursday, November 17, 2016 at 7:30 AM – Download a PDF Flyer of the Dietary Supplements Industry Compliance workshop

Overview

It has been more than 6 years since the final implementation of 21CFR Part 111. We continue to see warning letters issued by the FDA to the industry for non compliance with the regulations.

This is a clear indication that there is still a need for better understanding of the regulations and alignment between the agency and the industry. And now we have FSMA (Food Safety Modernization Act), signed into law by President Obama in January 4, 2011. FSMA Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016. This event will bring together both the FDA and the industry leaders to discuss the state of compliance and FSMA’s impact on the Dietary Supplement industry. We will hear directly from the FDA, subject matter experts and industry leaders coming from the different sectors of the Dietary Supplement Industry.

Agenda

7:30-7:50 Registration

7:50-8:00 QLN initiatives: Rosario Quintanilla- Public Affairs Specialist, FDA

8:00- 8:15 Welcome Address: CDR Steven Porter- Los Angeles District Director, FDA

8:15-9:30 FSMA: FSVP, Impact on DS and Raw Material Suppliers

• Dan Solis- LA Director of Imports Operations, FDA
• Dr. Teresa Cain – Import Compliance Officer, FDA
• Joy Joseph – President JQMS

9:30-9:45 Break

9:45-10:45 NDI, Draft Guidance : Cara Welch Ph.D.- Senior Advisor, Office of Dietary Supplement Programs, FDA

10:45-12:15 Industry Self Regulation to Safeguard Dietary Supplement Quality and Safety:

• Raw Material Supplier – Rupa Das, VP of Global Quality and Compliance-Botanical International
• DS Manufacturer- Gary Swanson , Sr. Vice President Global Quality-Herbalife
• Product Owner- Guru Ramanathan, SVP & Chief Innovation Officer-GNC

12:15-12:45 Lunch and Networking

12:45-1:45 DS Panel continued….

• Trade/3rd Party Organization – David Trosin Business Development Director- NSF
• Testing Laboratory- Elan Sudberg, CEO- Alkemist

1:45-2:45 Q&A

2:45-3:00 Break

3:00-3:30 Prop 65: Ann Grimaldi- Principal Grimaldi Law Offices

3:30-4:10 FDA Update: Daniel Cline- Los Angeles District Compliance Division, FDA

4:10-4:50 Compliance with DS Regulations-Investigator’s Perspective: Sarah Dent-Acosta- Food Specialist, FDA

4:50-5:00 Sponsor’s Presentation: Lewis Casey- ASQ

Organizing Committee

Chairs

Dr. Marlene Garcia-Swider, Quality System Manager, FDA-Los Angeles District Office

Nora Dowell, VP, Quality/Regulatory Affairs, International Vitamin Corporation

Rosemarie Christopher, CEO, MEIRxRS

Members

Nighat Ansari- Best Formulations

Bel Canosa– Glanbia

Lewie Casey– MEIRxRS

Lance Harding– Herbalife

Joy Joseph– QMS

Andrea Lester– NAI

Kelly Sheppard– FDA

Dan Solis- FDA

Pat Wratschko, Stauber

What Do You Want To Do Next?

1. Register for the Compliance of the Dietary Supplement Industry, Nov 17, 2016
2. Get help with FSMA (Food Safety Modernization Act)
3. Learn about the Quality Control Technician Apprentice Program
4. Speak with someone about my staffing needs
5. Learn about full-time recruiting services
6. Submit my resume