September 26-27, 2018
With a special section on applying GMP concepts to the Cannabis Industry
Presented in Cooperation with the American Herbal Products Association (AHPA)
The Good Manufacturing Practices (GMPs) dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to comply with even the basic tenants of the regulation. In addition, as states begin to regulate legalized cannabis, the concern of how GMPs apply to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations.
EAS Consulting Group in cooperation with the American Herbal Products Association (AHPA) will be conducting a two-day intensive Dietary Supplement GMP Seminar to help firms understand their responsibilities and requirements under 21 CFR 111, while also assisting the cannabis industry in understanding how these principles can be applied to their manufacturing operations. Given by former FDA compliance officials and industry experts, this training program will provide a thorough overview of compliance expectations, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.
$1,000 All AHPA members (use discount code: EAS_AHPA)
Group Rate, two or more from the same firm – 10% per person (use discount code: GROUP10)
Federal/State Government Employees – 50% per person (use discount code: GOV50)
Registrants with Promotion codes – Limit one Promotion code per transaction
Dates and Location
September 26-27, 2018
1933 Main Street
Dallas, TX 75201
The Hotel Indigo has extended a discounted guest room rate to registrants of the EAS-AHPA Dietary Supplement GMP seminar. Please make your guest room reservation no later than September 5, 2018, using this dedicated registration link or call the hotel directly and mention EAS Consulting Group.
|1||Introduction and GMP Overview||Couch||15||8:00 AM - 8:15 AM|
|2||FDA Enforcement||Ullman||45||8:15 AM - 9:00 AM|
|3||Subpart B - Personnel||Fish||30||9:00 AM - 9:30 AM|
|4||Subpart C - Physical Plant & Grounds||Fish||45||9:30 AM - 10:15 AM|
|Break||15||10:15 AM - 10:30 AM|
|5||Subpart D - Equipment & Utensils||Fish||30||10:30 AM - 11:00 AM|
|6||Subpart G: Components, Packaging, and Labeling||Couch||30||11:00 AM - 11:30 AM|
|7||Subparts H & I - Master Manufacturing and Batch Production Records||Fish||45||11:30 AM - 12:15 PM|
|Lunch||45||12:15 PM - 1:00 PM|
|8||Subparts K & L: Requirements for Manufacturing, Packaging, and Labeling Operations||Fish||30||1:00 PM - 1:30 PM|
|9||Subpart E: Specifications and Testing||Couch||90||1:30 PM - 3:00 PM|
|10||Subpart E: Representative and Reserve Samples||Couch||15||3:00 PM - 3:15 PM|
|Break||15||3:15 PM - 3:30 PM|
|11||Subparts M: Holding and Distribution Operations||Fish||30||3:30 PM - 4:00 PM|
|12||Quality Agreements||Ullman||45||4:00 PM - 5:15 PM|
|13||Work Session I||Couch/Fish||30||4:45 PM - 5:15 PM|
|14||Additional Q&A||Couch/Fish||15||5:15 PM - 5:30 PM|
|1||Documentation and Change Control||Couch||45||8:00 AM - 8:45 AM|
|2||Subpart F: Quality Control||Couch||30||8:45 AM - 9:15 AM|
|4||Subpart N: Returned Dietary Supplements||Couch||15||9:15 AM - 9:30 AM|
|5||Subpart O: Product Complaints||Couch||45||9:30 AM - 10:15 AM|
|Break||15||10:15 AM - 10:30 AM|
|6||Investigations and Material Reviews||Couch||60||10:30 AM - 11:30 AM|
|7||Subpart J: Laboratory Operations||Couch||45||11:30 AM - 12:15 PM|
|Lunch||30||12:15 PM - 1:00 PM|
|8||Dietary Supplement Test Methods||Couch||45||1:00 PM - 1:45 PM|
|9||Dietary Supplement Stability Programs||Couch||45||1:45 PM - 2:30 PM|
|10||Work Session II||Couch/Ullman||30||2:30 PM - 3:00 PM|
|Break||15||3:00 PM - 3:15 PM|
|11||Managing FDA Inspections||Ullman||90||3:15 PM - 4:45 PM|
|12||Exam||Couch||15||4:45 PM - 5:00 PM|
Who Should Attend?
- Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing, labeling, packaging, storing and distribution of dietary supplements and cannabis products.
- Consultants, auditors, attorneys and others interested in learning about the requirements of the dietary supplement GMPs and how they should be applied.
At the Dietary Supplement GMP Seminar, You Will
- Receive detailed practical guidance on how to apply the GMP requirements.
- Be given an opportunity to demonstrate your understanding of GMPs in group work sessions.
- Be coached on how to prepare for an FDA inspection and how to avoid receiving a List of Objectionable Inspection Observations (Form FDA 483) and the end of an FDA inspection.
- Participant’s Manual with copies of the presentation slides
- Pocket Guide: 21 CFR Part 111
Dr. Tara Lin Couch, EAS Senior Director, Dietary Supplement and Tobacco Services
Dr. Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in both pharmaceutical and dietary supplement manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a consultant, Dr. Couch has assisted numerous dietary supplement companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.
Robert Fish, EAS Independent Advisor, Quality and Compliance
Mr. Fish joined EAS Consulting Group, LLC in November 2006 after 10 years consulting for FDA regulated industries. He spent 33 years with the Food and Drug Administration (FDA), the last six years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962 and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.
Marc Ullman, Of Counsel at Rivkin Radler, LLP.
Attorney Marc Ullman represents clients in matters relating to all aspects of the firm’s practice, including Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white-collar criminal defense firms for 10 years, where he represented clients in both federal and state prosecutions, as well as numerous related civil matters and other litigations.
Minimum Registration Policy
Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by August 15, 2018, and refund the registration fee in full.
Cancellations received before August 15, 2018, will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as notice is given to EAS in advance.
For More Information
Contact Amy Scanlin at 571-447-5508 or email@example.com
EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost-effective alternative to train your employees. It also allows the program to be tailored to your particular needs. Contact us for more information.