American Herbal Products Association Educational Seminars Present:
GMP Compliance: An AHPA Tele-Seminar Series
(Silver Spring, MD, June 28, 2006) -- FDA’s final
dietary supplement GMPs have been under development for more than a decade, but it is still anyone's guess when these regulations will finally be published.
Even today though, dietary supplement manufacturers are required to comply with the same GMP standards that apply to food producers. And many herbal companies have imposed higher standards on their own facilities to keep up with their customers’ increasing demands for product quality.
How does your company’s GMP measure up to current industry standards?
Are you ready to comply with FDA’s new rules?
- AHPA has designed a series of tele-seminars on GMP compliance for supplement makers to cover GMP issues that are relevant both today and to assist in transitioning to the new rules when they are published.
- Each tele-seminar will include presentations by a panel of experts with specific knowledge and experience, relevant to the numerous topics included in each seminar.
- Useful documents will be distributed at each tele-seminar, and a written transcript will follow each event.
Currently planned tele-seminars include:
- Introduction to Good Manufacturing Practices For Dietary Supplement Products: Strategies for Compliance - August 3, 2006.
- Botanical Identity/Herb Quality - September 28, 2006.
- The Quality Unit - Early November, 2006. Date to Be Announced.
If you manufacture an herbal product, you will learn how to evaluate your current GMP system and to prepare for new demands that may soon be included in FDA’s final rule on dietary supplement GMP. Be ready before the FDA knocks at your door – make sure your company is prepared.
Register for one or all on AHPA’s website: http://www.ahpa.org/portals/0/pdfs/06_08_AHPA_cGMP.xls Either fax back the form or return by email.
1. Introduction to Good Manufacturing Practice for Dietary Supplement Products: Strategies for Compliance (click for course outline)
Date: August 3, 2006 • Time: 1pmET – 3pmET
Objective: This practical introduction will provide insight into some critical GMP systems that you should have in place. The expert panel will provide a background to the GMP for dietary supplements, FDA authority, DSHEA, the goals of the GMP, and an overview of how compliance and FDA oversight works. It will also offer the basics of how to create the organizational structure for your business, including personnel, documentation, systems, facility and SOP creation. The seminar will also help you anticipate business impacts and costs of compliance.
2. Botanical Identity/Herb Quality (click for course outline)
Date: September 28, 2006 • Time: 1pmET – 3pmET
Objective: The foundations of the herbal products industry rely upon purchasing quality herbs and herbal extracts, qualifying vendors, and confirming herb identification. Ensuring that herbs and herbal products meet all specifications for quality, compliance, and safety is no simple matter. This session will provide both basic and advanced tools for herb identification, preventing adulteration, and quality measurements.
3. The Quality Unit (click for course outline)
Date: Early November. Date to be announced • Time: 1pmET – 3pmET
Objective: This session will address the critical requirement to have an independent quality group within your company, the responsibilities and authority of the quality group, and how to manage quality for product excellence, consumer safety, compliance, company liability, and practical cost considerations.
Where: Your telephone or office conference room
Cost: $195 per tele-seminar, per listening site for members / $495 per listening site for non-members (no matter how many people are in the room)
Registration: register for one or all three with this online form to fax or email back: http://www.ahpa.org/portals/0/pdfs/06_08_AHPA_cGMP.xls
Advance registration only; the deadline is one week prior to each event. Once registered, a confirmation email will be sent to you within two days and all supporting resource documents (developed specifically for each tele-seminar) and instructions will be sent by email 48 hours prior to the event. If you have any questions, please contact Devon Powell at [email protected], or 301-588-1171, x102.
Each tele-seminar begins at 1:00 pm ET / 12:00 noon CT / 11:00 am MT / 10:00 am PT and lasts for two hours. The cost of participation per tele-seminar is $195 (AHPA Members) / $495 (non-members) per connection. This includes an unedited transcript and a Certification of Completion, an important addition to cGMP compliance training and personnel files; additional certificates cost $25 each. An audio CD will be available for an additional $25.
AHPA’s tele-seminars are a convenient and cost-effective way to explore issues, gain insight and enhance knowledge important to your herbal and dietary supplement business. You will be provided with very useful documents to assist with GMP compliance. The tele-seminars are live telephone conference calls. Please note, the registration fee is charged per phone connection, but as many staff members as you wish may listen in on your speaker phone.
### The American Herbal Products Association (AHPA) represents the core of the botanical
trade -- comprised of the finest growers, processors, manufacturers and marketers of
herbal products -- AHPA’s mission is to promote the responsible commerce of herbal
products. AHPA committees generate self-regulations to ensure the highest level of
quality with respect to the way herbs are manufactured, labeled, and sold.