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The Natural Products Association Presents:

An Advanced Course on the Final FDA GMP Rule for Dietary Supplements

(This is a one and a half day course)

FDA has published several warning letters for violations related to dietary supplement GMPs! Learn how to avoid this happening to your company.
Not only has FDA issued several warning letters for GMP violations, they have also recently posted their inspection compliance plan for dietary supplements. NPA and our seminar presenters have many years of experience evaluating warning letters and compliance plans to determine the Agencys expectations. NPAs program incorporates this new information into its agenda, and presenters will share their expertise during the seminar. Attending the NPA seminar will prepare your company for when the FDA knocks on your door. Additionally, you will leave the seminar understanding what to expect during an inspection and how to respond to interactions with FDA officials. As the leader in dietary supplement GMPs, having launched the industry's first GMP third-party certification program in 1999, and providing the first and best dietary supplement focused GMP education to over 950 companies for more than 12 years, NPA presents an outstanding program. Our seminar provides realistic training and tools with topics that are relevant and timely - focusing on key GMP issues and those items addressed in recent FDA warning letters, inspections, and on 483 observations. Our speakers are industry experts that have worked with numerous industry firms of all sizes to help them develop and implement effective quality systems and successfully achieve GMP certification, Australia's TGA registration, and resolve FDA-related issues. Documentation is the foundation of GMP compliance and FDA warning letters frequently cite problems with inadequate company SOPs and records: get practical tips from our presenters who have worked with hundreds of dietary supplement firms on developing comprehensive FDA-compliant SOPs and records versus "ISO-light" documentation. Seminar presenters include Cindy Beehner, President, QSD Consulting; Aaron Secrist, Quality & Regulatory Manager, NOW Foods; and Natural Products Association staff. Seminar presenters have over 40 years combined experience in addressing FDA regulations, especially in the area of good manufacturing practices and dietary supplements. Ms. Beehner and Mr. Secrist have first-hand experience working for dietary supplement manufacturers and as consultants working with industry to meet the challenges of compliance to the laws and regulations related to dietary ingredients and dietary supplements. This course is relevant and valuable for anyone whose job responsibility requires a comprehensive understanding of the FDA GMP rule for dietary supplements, including senior management and regulatory affairs, QA/QC, production, and laboratory personnel. The seminar agenda will include: Overview of FDA GMPs Comprehensive discussion of specific FDA GMP requirements including establishing and confirming specifications, QC personnel responsibilities, laboratory operations, scientifically valid analytical methods, raw materials and finished product testing requirements, and change control Developing GMP-compliant SOPs, master manufacturing and batch production records, and other required documentation Qualifying your suppliers and other vendors to ensure quality and consistency in meeting GMP compliance (a hot topic with FDA!) Qualifying certificates of analysis to allow for reduced testing of components Third-party certification How to handle visits from the FDA and discussion of FDA expectations based on recent FDA GMP inspections Tips on getting started incorporating new FDA GMP requirements within your companys current GMP systems Opportunity for technical question and answer discussion with industry GMP experts

2011 Seminars Will Be Presented In Conjunction With The Following Tradeshows:


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Natural Products Association MarketPlace Las Vegas, NV (June 22, 8 a.m. 5 p.m. & June 23, 8 a.m. - noon )* Expo East Baltimore, MD (September 21 , 8 a.m. 5 p.m. & September 22, 8 a.m. - noon) Located Close to an Industry Supply Show Las Vegas, NV (October 10 , 8 a.m. 5 p.m. & October 11, 8 a.m. - noon)
See registration form on page 2 for NPA MarketPlace Show Special!

REGISTRATION FORM: Final FDA GMP Rule for Dietary Supplements Seminar
Name(s) & Title(s)

Company Address City/State/Zip Phone Email (confirmation sent by email) Registrations must be accompanied by check or credit card information. Registration substitutions may be made at any time. All requests for refunds are subject to a $100.00 processing fee. Refunds will be issued if notification is postmarked, emailed or faxed five (5) business days prior to the day of the seminar. Natural Products Association reserve the right to make program changes as necessary or to cancel the program if minimum enrollment has not been reached or events occur beyond the reasonable control of the Natural Products Association. Ext. Fax:

Please send completed registration form with payment to: Natural Products Association, P.O. Box 347136, Pittsburg, PA 15251-4136 If paying by credit card, please fax your registration to (202) 223-0250 All registrants will receive a confirmation notice five (5) business days before the seminar. Credit Card # CID Number (usually on back of card) Authorized Signature Credit Card Billing Address Expiration Date

FEES (10% discount for multiple registrants from the same company)*
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NATURAL PRODUCTS ASSOCIATION Member: $745 or $670.50 per attendee for multiple registrants from same company* Non-NATURAL PRODUCTS ASSOCIATION Member: $995 or $895.50 per attendee for multiple registrants from the same company*

$ $

TOTAL AMOUNT

Please mark seminar you will attend: Natural Products Association MarketPlace Las Vegas, NV (June 22 & 23)* Expo East Baltimore, MD (September 21 & 22) Close to Industry Supply Show (West Coast) Las Vegas, NV (November 10 & 11)

NPA MarketPlace Show Special! Registrants who attend the NPA labeling seminar scheduled during Natural Products Association MarketPlace 2011 and this seminar will receive a 10% discount on both seminars. Multiple registrants from the same company that attend both seminars will receive a 20% discount.
Call Vicki Whitsitt at 202-503-1961 for more information

Pre-registration deadline is 5 business days prior to the day of the seminar. Those who do not pre-register can register onsite, space permitting, for an additional fee of $100.00 per attendee.