Module 1 - "Overview of the GMP Inspection and Preparing for the Inspection"
January 23, 2024, 1:00 – 3:00 pm ET

Module 2 - "What to Expect During and After the GMP Inspection"
January 24, 2024, 1:00 – 3:00 pm ET

Course Description: Join us as we share invaluable tips on how to navigate the FDA inspection process! CRN and NSF jointly present this exclusive and invaluable course on achieving dietary supplement GMP compliance (21 CFR 111). Whether you're a newcomer to the world of dietary supplements or a seasoned pro in need of a refresher, this course is your ticket to GMP inspection success.

Get the inside scoop from a seasoned instructor and an in-house legal counsel with an accomplished track record of managing inspections. We'll show you how to prepare your personnel and facilities well in advance of the FDA's arrival, guide you through the intricacies of the inspection process, and teach you the ins and outs of closing an inspection effectively, even in the face of FDA observations in a Form 483.

Attendees will be fully briefed on what to expect and how to prepare for a GMP inspection that leads to a positive outcome. Hurry, as this premier course is limited to just 50 spots. Register today to reserve yours!

Format: This course is an engaging two-day event, featuring two 90-minute modules brimming with expert insights, real-life stories, and ample time for your questions. Each 90-minute module will be followed by Q&A.

Registration Fees:

CRN Members: $299 per module
Non-Members: $349 per module

Group Rate!
Sending 3 or more registrants? Contact menglish@crnusa.org to find out how to register under this special rate.

CRN Members: $249 per module
Non-Members: $299 per module

Certificates: Upon completing both modules, each attendee will receive a certificate of completion.

Learning Objectives:

Delve into the regulatory intricacies surrounding FDA’s inspection process.
Gain insight into what unfolds during dietary supplement GMP inspections.
Unlock the secrets to pre-inspection success with a focus on crucial preparatory steps.
Discover the keys to managing the inspection process strategically, and how to handle unexpected challenges to ensure optimal outcomes.
Learn how to distinguish between the questions inspectors can and cannot ask, and how to navigate the tricky ones that arise.
Prepare your employees to shine during their questioning by inspectors.
Unveil the essential elements of post-inspection follow-up activities, ensuring a optimal conclusion for your company.

Who Should Attend:

Quality and regulatory management
Manufacturing management
Facility personnel engaged in manufacturing and distributing
Legal counsel

Cancellation Policy: Due to limited seating, we request you cancel no later 30 days before the event. A full refund minus a processing fee will be issued for cancellations made by this deadline. Please contact Maya English at menglish@crnusa.org to cancel.

Module 2 - What to Expect During and After the GMP Inspection