UNPA Seminar: Mock FDA GMP Inspection for Dietary Supplements - Learn What to Do and How to Pass

This one-day seminar is conducted as a true mock inspection where each part of the process will be broken down, role-played, discussed and analyzed. Attendees will receive a template SOP for FDA inspections.

Two former FDA inspectors with nearly 50 years of combined experience will lead the seminar. And meet current FDA inspectors for a Q&A opportunity.

May 28, 2009 Salt Lake Marriott center Salt lake City, UT

Seminar Program

8:00 – 8:30 am
Registration / Continental Breakfast

8:30 – 8:45 am
Welcome / Review of the Day / Introduction of Speakers
Loren Israelsen, Executive Director, United Natural Products Alliance (UNPA)

8:45 – 9:45 am
SESSION I: The Inspection Begins
Shelly Maifarth, Retired FDA Compliance Officer
Martina LaGrange, Former FDA Consumer Safety Officer
• The 482 form
• Initial meeting
• Into the factory

9:45 – 10:45 am

SESSION II: The Walk-Through
Shelly Maifarth / Martina LaGrange
• Quarantined to finished goods inspection
• Visiting the lab
• Inspecting records

10:45 – 11:00 am

11:00 am – 12:15 pm
SESSION III: Inspectional Observations — Form 483
Loren Israelsen
• What do you do now?
• A review of 483’s of DS manufacturing facilities, including NBTY and others

12:15 – 1:15 pm

1:15 – 2:15 pm
SESSION IV: Meet the Inspectors Before You are Inspected
FDA Representatives Invited

2:15 – 3:00 pm
SESSION V: Q & A with Past and Present FDA
Shelly Maifarth / Martina LaGrange and FDA Representatives

3:00 – 3:30 pm
SESSION VI: Inspection Hot Spots
Loren Israelsen
• Sterilization, total plate count and irradiation
• Record keeping; SOPs
• Analytical testing validation and challenge tests by FDA
• Access to sensitive records — when to say no
• When, if ever, do you bring in the lawyers?

3:30 – 4:00 pm

4:00 – 4:45 pm
SESSION VII: Food Safety Legislation — Will Congress Really Overhaul FDA and the Food Safety System? A Look at the New HHS, FDA and USDA
Loren Israelsen

4:45 – 5:00 pm
Summary and Conclusions of Seminar

Click here
to download the registration form.
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