GMP Inspection: Being Perfectly Prepared When the FDA Comes Knocking — Module 1

"GMP Inspection: Being Perfectly Prepared When the FDA Comes Knocking:"

• Module 1 — "Overview of the GMP Inspection and Preparing for the Inspection"

• Module 2 — "What to Expect During and After the GMP Inspection"

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.

• Secure your spot—this premier course is limited to just 50 spots.

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

Register FOR MODULE 1 here

Register for Module 2 here.

Registration Fees:

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

Group Rate!
Sending 3 or more registrants? Contact Maya English to find out how to register under this special rate.
CRN Members: $249 per module
Non-Members: $299 per module

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

Hear from:

Taneesha (Routier) Rogers, J.D.
Director of Regulatory Affairs, XYMOGEN

Taneesha (Routier) Rogers J.D. is the Director of Regulatory Affairs at XYMOGEN in Orlando, Florida. As the legal, regulatory, and compliance leader at a prominent dietary supplement manufacturer and global brand she focuses her time and talents on supporting executives by ensuring facility and regulated consumer product compliance and serving as a strategic partner in risk mitigation and supporting the development of innovative and novel initiatives. Her passion for responsible and compliant practices is evidenced in her thought-provoking engagement and participation as a leader of timely industry topics trainings and panels and her leadership as a chair of the Council for Responsible Nutrition (CRN) Legal Committee- a prominent trade organization furthering the agenda of responsible dietary supplement company operations. Taneesha received her J.D. from Florida A&M University- College of Law, her master’s in management from the University of Maryland, and her B.A degrees from Old Dominion University. With over a decade of experience in the regulatory consumer goods compliance space she continues to use her skills to balance business stakeholder demands through strategic compliance program development, implementation, and risk management, and support the furtherance of responsible industry.

Nicole Leitz
NSF Consultant

Nicole has over twenty years of experience within the Good Manufacturing Practices (cGMP) industries for food, dietary supplements, pharmaceuticals, OTC’s and medical devices. She’s written and presented numerous training sessions on Quality System elements and practices for the 21 CFR regulated industries to corporate clients. In addition to these activities, Nicole also works as a remediation consultant where she has advised on and written documentation such as SOPs, WIs, investigations, CAPAs and Complaint Investigations for corporate clients. Lastly, Nicole has written, executed and trained industry personnel upon the regulatory aspects of Validation (Vmodel) for software and analytical instrumentation. She has a Master of Science degree in Organic Chemistry from Bucknell University and a ACS BS degree in Chemistry from Hope College.

Register FOR MODULE 1 here

Register for Module 2 here.