Join this webinar to explore key findings from the Global Food Safety Training Survey, such as organizations with a strong training program are 12X more likely to have strong, consistent adherence to established protocols on the floor.
As the most comprehensive research conducted on food manufacturer training, the data provides an opportunity to benchmark your employee training program with industry peers to identify your strengths & opportunities for improvement.
What you will learn:
- Key metrics where above average training programs outperform peers in food safety, compliance, productivity, engagement, and retention
- What high-performing facilities do differently when designing, delivering, and managing training
- Common barriers that keep programs stuck at “good enough”—and practical ways to overcome them
- Where emerging capabilities (including AI) can make training more consistent, scalable, and effective
Join us for this deep dive into the research and how to apply the findings. Registrants will receive a complimentary copy of the Global Food Safety Training Survey Research Paper.
Speakers
Laura Dunn Nelson, Founder, Culture Strategies Group
Bertrand Emond, Culture Excellence Lead, Campden BRI
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.
