American Association of Homeopathic Pharmacists

The American Association of Homeopathic Pharmacists Present Compliance Through Education: Preparing For – And Surviving – an FDA Inspection

5112 Wilshire Drive

Santa Rosa, CA 95404

1-800-478-0421

Preparing For – And Surviving – an FDA Inspection

In response to numerous member requests, the AAHP is offering a new course to help prepare companies for FDA inspections and assist them with management of the inspection and follow-up. As part of the AAHP's continuing commitment to Compliance Through Education, the course will provide practical insight into the FDA inspection process, what the inspectors expect to see, and assist attendees with strategies and techniques in order to ensure a successful outcome from an FDA inspection. The course provides a background and understanding of the role played by the FDA, its administrative and enforcement powers. It will go step-by-step through the entire inspection process and describes the various types of inspections including routine GMP inspections and product label reviews. It will also address 483s and warning letters.

The instructor Owen B. Lamb is a renowned homeopathic industry GMP/QA consultant. He has over 20 years of experience with the FDA as well as senior pharmaceutical corporate level quality assurance positions.

This course will be held March 11 & 12, 2002 at the WestCoast Anaheim Hotel in Anaheim, CA.The course is being offered immediately following the Natural Products ExpoWest show to minimize travel expenses and make it easier for management teams to attend together. Registrations and payments must be received at the AAHP office by February 21^st. Contact the AAHP office for more information at 1-800-478-0421.

Pharmacists will earn 1.2 hours of Continuing Education Credit (=12 CEUs). All attendees will receive a certificate of completion from the CPA.