GMP training is a regulatory requirement under FDA 21 CFR Part 117, and a critical foundation for ensuring safe, sanitary food production. But translating these requirements into an effective, auditable training program can be a challenge for many food manufacturers.
In this webinar, we’ll break down GMP training requirements into clear, actionable steps, covering what must be trained, who needs training, when it should occur, and how to maintain proper documentation. You’ll gain a practical understanding of how to align your training program with regulatory expectations while improving workforce performance and audit readiness.
Key takeaways:
- How to structure your GMP training program around core regulatory requirements
- How consistent GMP compliance strengthens food safety culture
- Best practices for onboarding, refresher training, and role-specific learning
- How to simplify training documentation and maintain audit-ready records
Join us for a practical, step-by-step discussion designed to help you build or strengthen your GMP training program with confidence. Registrants will receive a complimentary copy of the GMP Training Guidebook for Food Manufacturers.
For Medical Device Establishments, who must register?
Owners or operators of establishments involved in producing and distributing medical devices intended for the U.S. market must register annually with FDA and pay an annual registration fee.
What information is submitted for medical device establishment registration?
In addition to registering with FDA, most owners or operators of medical device establishments must also submit a list of all devices during their annual registration renewal.
- U.S. Facilities
- Initial importers must identify the manufacturers of the devices they are importing.
- A device must be listed if they fall under the any of the following:
- Contract Manufacturer
- Contract Sterilizer
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U. S. manufacturer of export only devices
- Non-U.S. Facilities
- Must list devices, provide a U.S. Agent, and identify importers.
Who must provide medical device listings?
In most cases, all medical device establishments required to register with FDA must also submit a complete list of medical devices manufactured for commercial distribution in the U.S. market.
All facilities that fall under any of the following functions:
- Contract Manufacturer
- Contract Sterilizer
- Foreign Exporter
- Manufacturer
- Relabeler / Repackager
- Remanufacturer
- Reprocessor of Single Use Device
- Specification Developer
- U.S. manufacturer of export only devices
What information is submitted for a medical device listing?
Medical device establishments must list any medical device made in the establishment and the activities the device is meant for.
- Company function (activity)
- Device product code
- Proprietary names
- Importer information
What is a master file?
A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.
