Skip Main Navigation
Page Content

Save This Event

Event Saved

The 2nd Annual Dietary Supplement Consortium

ASQ Food, Drug, and Cosmetic Division

Friday, April 27, 2018 from 7:00 AM to 5:00 PM (PDT)

The 2nd Annual Dietary Supplement Consortium

Ticket Information

Ticket Type Remaining Sales End Price Fee Quantity
ASQ Members 1 Ticket Apr 26, 2018 $49.00 $0.00
Non-ASQ Members 4 Tickets Apr 27, 2018 $99.00 $0.00
Exhibitors 4 Tickets Apr 27, 2018 $200.00 $0.00
Speaker Sold Out Apr 27, 2018 Free $0.00
Complimentary Sold Out Apr 27, 2018 Free $0.00
Volunteers Sold Out Apr 27, 2018 Free $0.00

Share The 2nd Annual Dietary Supplement Consortium

Event Details

To view the program flyer please click the following link http://www.ccicna.com/en/food/dietary-supplement-workshop.pdf

For Hotel and Dining Information Click the following link https://www.ccicna.com/en/dietary-supplement-workshop/ 

Interested in becoming a member of ASQ?  Please click here to find out more https://asq.org/membership/become-a-member?origin=sitelink&gclid=CjwKCAjwhcjVBRBHEiwAoDe5xyj-Xnu7AbnNTym0neSfDC2sqgAhdKzH6LmGv3Ooo8PmEy62rkPBmBoCrVoQAvD_BwE

Speaker's Bios

Dan Solis,  Director, Division of West Coast Imports, Office of Enforcement and Import Operations, FDA

Mr. Solis started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug application Products. Mr. Solis has held many positions within FDA that include working at FDA HQ, working at FDA HQ IT and working on enforcement cases out in the field. Mr. Solis was selected to be the Director of the Los Angeles District Imports Operations Branch in November 2009. He now directs one of the largest FDA Import Offices, nationally and oversees the largest port in The United States.

Among his many accomplishments in FDA, Mr. Solis has led these initiatives: Implementation of PREDICT at all ports in the US, the implementation of electronic communications and paperless transactions initiatives with the Importing Trade, formation of the CBP/FDA Team - Team FDR, implementation of ACE training and workshops in the Southern California area, formation of a Port operations steering committee in the West Coast and development of strong partnerships with the filers and brokers in the Southern California area. Mr. Solis is nationally recognized as a subject matter expert in the program area of Import Operations and gives local, as well as, national training on Imports Investigations. He is a member of the National Leadership Development Workgroup at FDA’s DHRD, has served as a mentor for the Federal Executive Board in Los Angeles, member of the FSMA Workgroup at HQ working on FSVP implementation. He also has had integral roles in FDA Operations with other Federal Agencies, working with CBP, ICE, HSI, USDA, FWS, DEA and State and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team as well as the Associate Commissioner’s IT Advisory Workgroup and the Associate Commissioner’s Import Advisory Panel.

He also serves a one of the Pacific Region Import Consistency and Timeliness Workgroup (ICAT) steering committee member.

Mr. Solis holds a Masters Degree in Healthcare Administration from the University of LaVerne and a Bachelor’s Degree from University California of Irvine.

Dr. Cara Welch, Sr. Advisor, Office of Dietary Supplement Programs (ODSP), FDA

Cara Welch, Ph.D., is Senior Advisor for the Office of Dietary Supplement Programs (ODSP) in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). In this role, Dr. Welch works on new policies and programs involving regulatory compliance matters for the dietary supplement industry.  She joined FDA in 2014 as a chemist and utilizes her background to provide guidance on ODSP’s research program. Prior to FDA, Dr. Welch was the Senior Vice President of Scientific and Regulatory Affairs at the Natural Products Association.  Welch earned her Ph.D. in Medicinal Chemistry from Rutgers University working with traditional medicinal African plants. 


Sara J. Dent Acosta, M. S., Compliance Officer, FDA – OHHAFO – West V

Ms. Dent Acosta is a Compliance Officer for the Division of Human and Animal Foods - West V; she is located at the San Diego Resident Post. Prior to her current position, she was the Food Specialist for the Los Angeles District from 2010 to 2017 and has 18 years of experience as an investigator in the food area.

She has been working with the Dietary Supplement Regulations since the FDA began to draft the rules around 2000.  Ms. Dent Acosta participated with CFSAN in the roll out of the two Draft rules and in the presentation of the Final Rule to the stakeholders.

She is a member of the California Food Emergency Response team (CalFERT). She has participated in the training Cadres for Dietary Supplements, Acidified Foods and Seafood HACCP.

Prior to working for the FDA Sara taught General Biology, Ecology, and Botany at the University of Puerto Rico, Humacao Campus. She has an M.Ph. in Theoretical Ecology from SUNY Stony Brook, and a B.S. and M.S. in Ecology and Botany from the University of Puerto Rico, Mayaguez Campus, where she specialized in pollination ecology of tropical plants.


Dr. Roger Clemens, DrPH, CFS, CNS, FIFT, FASN, FACN, FIAFSTProf. USC School of Pharmacy

Dr. Roger A. Clemens is part-time faculty within the USC International Center for Regulatory Science program where he enjoys an adjunct appointment as Professor of Pharmacology and Pharmaceutical Sciences and Assistant Professor of Regulatory and Quality Sciences within the USC School of Pharmacy for the past 17 years. He also developed and facilitates graduate nutrition courses in the Global Medicine program within the USC School of Medicine. He served as Scientific Advisor for Nestlé USA for more than 21 years.

Dr. Clemens is a past president of the Institute of Food Technologists (IFT) and former member of the IFT Board of Directors. He co-founded, established and contributes to a Food, Medicine and Health column published monthly in Food Technology since 2004. Dr. Clemens was recognized by his peers as an elected Fellow for his distinguished contributions in nutrition and food science. He is a Fellow in the American Society for Nutrition, American College of Nutrition, Institute of Food Technologists, and International Academy of Food Science and Technology.

Dr. Clemens serves on several editorial boards (e.g., Food Chemical Toxicology, Journal of Food Science, Toxicology Research and Applications) and continues to serve as a reviewer for many journals, including but not limited to Journal of Nutrition, American Journal of Clinical Nutrition, Nutrients, Food Science and Technology. Not surprising, Dr. Clemens is well-published (> 50 original manuscripts and commentaries), has authored several book chapters at the nutrition and health interface, and is in the process of editing and writing new publications in starvation and nutrition, food regulations as well as food toxicology. In addition, Dr. Clemens is a respected communicator in the nutrition and health arena with more than 500 interview occasions across media types in the USA and internationally, and continues to be invited to speak at conferences and symposia.

Dr. Clemens received an AB in Bacteriology, a MPH in Nutrition, and a DrPH in Public Health Nutrition and Biological Chemistry from the University of California, Los Angeles.

                        Impact of Marijuana legalization to the Dietary Supplement and Food Industry

  1. There is little or no standardization in terms of extraction, preparation, or routine use of the forms of cannabis that are increasingly integrated with nutrients to make savory or dessert products.
  2. There is a paucity of safety data for such edible-marijuana containing products
  3. There is abundant accumulating data about the toxicologic effects of an entire spectrum of cannabinoids delivered via various forms of inhalation and via gastrointestinal absorption.
  4. Regardless of route of administration, regular cannabis use is associated with dysfunctional neurological processes and compromised structures.


Joy Joseph,  Joy's Quality Management Systems, Inc. 

Technical and Regulatory Consultant / Dietary Supplement, Pharmaceutical and Food Industries

EDUCATION:

Master of Business Administration Technology Management, University of Phoenix, 1997 Bachelor of Science

Chemistry and Biology, Xavier University, Louisiana 1960

Various Courses in Good Manufacturing Practices and Business Finance Loyola University, Los Angeles and University of Southern California

Training in Granulation, Tableting, and Gelatin Capsule Manufacturing Center for Professional Advancement, New Jersey (1990 - to present)

ASQ Certified Quality Auditor; Certification # 42912

Food Safety Preventive Controls alliance(FSPCA)- Lead Instructor for Preventive Controls Qualified Individual training

FSPCA- Lead Instructor for Foreign Supplier Verification Program training

 

EXPERIENCE:

April 2005 to present - President and Founder of Joy’s Quality Management Systems, Inc. Consultant and Lecturer - Research and Development (Pharmaceutical Dosage Forms); In House Training in Good Manufacturing Practices and Formulation Technology; Auditing for FDA or Other Regulatory Compliance; QC Laboratory Design and Set Up; Project Management; Assist Clients in preparation and training for Third Party GMP (Good Manufacturing Practices) Certification Programs; Job Descriptions and SOPs (Standard Operating Procedures) ;Ingredient and Finish Product Specifications and Testing; Development of Master Manufacturing and Batch Records; Corrective Actions for 483 or Warning Letter Compliance ;Lead Instructor for 21CFR Part 117 for Human Foods and for Foreign Supplier Verification Programs.

1998 to 2005 – Various Positions over a period of 24 years starting at Director of QC and R&D up to Vice President Science and Technology for Pharmavite LLC. Manufacturer of Branded and Private Label, Dietary Supplements and OTC Drugs (Tablets, and Capsules; both two piece and soft gelatin) Responsible for Quality, R&D, Technical Operations, Scientific Affairs and Consumer Education

September 1960 to January 1980 - Various Positions including Vice President of Manufacturing. Chromalloy Pharmaceutical, Inc.

PRESENTATIONS:

Various presentations to USP, Trade Associations, and News Media of Good Manufacturing Practices, Science behind Supplements, Stability Studies, Analytical Testing Methodologies. (Can be supplied upon request)

PUBLICATIONS:

  1. ” Regulation of Quality and Quality Issues Worldwide”, Regulation of Functional Foods and Nutraceuticals, First Edition, Blackwell Publishing LTD., Iowa, USA 2005
  2. “Formulation Challenges in the Dietary Supplement Industry, Vitamin and Minerals”, Pharmaceutical Dosage Forms, 3rd Edition, Taylor and Francis Group Publishing Inc., New York USA, 2008
  3. Various articles on manufacturing and quality in, Tablets and Capsules, CSC Publishing, Inc., MN USA, 2005 and 2006

AWARDS:

Steuben Apple Award, presented by the Council for Responsible Nutrition, for outstanding service to the Dietary Supplement Industry, 2005

Service awards, presented by, United States Pharmacopoeia, 1995- 2015,

Special Service Award presented by United States Pharmacopoeia, for “Beyond the Call of Duty Service” to the “Foods Chemical Codex”, 2007

AFFILIATIONS:

Earned recognition for working with the Council for Responsible Nutrition and other trade associations to draft a submission to FDA to be incorporated into the 21 CFR Part 111, Dietary Supplement Good Manufacturing Practices Regulations (cGMPs).

Lecturer and Course Director of Dietary Supplement Good Manufacturing Training class: Center for Professional Advancement, New Brunswick, New Jersey

Former Scientific Advisory Board Member, University of Southern California, Department of Pharmacy Graduate Student Program, Dr. Frances Richmond, Director

Former Scientific Advisory Board Member, University of Illinois, Chicago Campus,” Clinical Studies on Botanicals for Women’s Health” Dr. Norman Farnsworth, Study Director, 1997-2004


Dr. Theresa Cain, Import Compliance Officer, FDA

"Dr Cain's current functions include:


  • Review of Import Entries for Compliance of ocean, air and courier entries for all commodities
  • Recommendation for Import Alert revision (IA 21-05)
  • Addition to Import Alert of non-compliant firms and products recommendation for Customs and Border Protection (CBP) seizures
  • Frequent communication with industry, brokers and importers
  • Partnering with CBP for fines, penalties and forfeiture regulatory actions
  • Case development for submission to center for regulatory actions pesticide laws and nanomaterial regulation.  Her diverse client base consists of entities operating across supply chains, from chemical manufacturers to consumer product retailers, and in varied industries including dietary supplements, electronics, auto manufacturing, and art materials.


Previous employment includes Ribapharm, a subsidiary of ICN Pharmaceuticals, Cortex Pharmaceuticals and Magellan laboratories where she held a number of analytical and supervisory works.

Dr Cain earns her Ph.D. in Analytical Chemistry from the University of Michigan where she developed a rapid identification technique analyzing bacterial components by mass spectrometry using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) and liquid chromatography/electrospray ionization mass spectrometry (ESI MS), her M.S. in Environmental Engineering from the University of Michigan and her B.S. in Chemistry from Florida International University. 

Dr Cain authored a number of publications and is an affiliate of American Organization of Analytical Chemists, American Chemical Society, American Society for Mass Spectrometry. "     

                                                                      

Organizing Chairs:

Nora Dowell, VP Quality/Regulatory Affairs International Vitamin Corporation ASQ-FD&C, DS Community of Excellence 

Dan Solis,  Director, Division of West Coast Imports, Office of Enforcement and Import Operations, FDA Dowell

Richard Lee, General Manager Dept. of Agri-Products & Food CCIC North America Inc. 

 

Organizing Members:

Nighat Ansari, Best Formulations

Bel Canosa,  Glanbia

Lewie Casey,  ASQ, RxResearch Foundation

Rosemarie Christopher, Rx Research  Staffing and Foundation

Andrea Groncy, IVC

Lance Harding, Herbalife

Virgnia Hill, Pharmavite 

Noreen Hobayan, Glanbia

Joy Joseph,  Joy's Quality Management Systems, Inc.

Frances Liu,  Amway

Jason Ruckert, Pharmavite 


Program Moderator: Stephen Joseph, CQA, CHA, PCQI, COO Joy's Quality Management Systems, Inc.

 

Do you have Certifications?  Attendance to this event is good for 1.0 Recertification Units.

Have questions about The 2nd Annual Dietary Supplement Consortium? Contact ASQ Food, Drug, and Cosmetic Division

Save This Event

Event Saved

When & Where


CCIC North America
8835 Haven Avenue
Rancho Cucamonga, CA 91730

Friday, April 27, 2018 from 7:00 AM to 5:00 PM (PDT)


  Add to my calendar
The 2nd Annual Dietary Supplement Consortium
Things to do in Rancho Cucamonga, CA Conference Health

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.