“While you provided some written procedures for quality control operations, your warehouse manager stated that your firm has not been following such procedures…”
– Extract from FDA Warning Letter to dietary supplement manufacturer, April 2013.
As the above extract shows, if you are involved in the manufacture of products such as dietary supplements, you will need to satisfy authorities such as FDA that you have proper quality systems in place and that your personnel are trained to implement them!
For the past 15 years Skillpad has been helping FDA-regulated companies to meet their training needs and is excited to announce the release of 2 new additions to its extensive library of e-Learning courseware.
The new e-lessons GMP – SOPs in Nutraceutical Manufacturing and GMP – Records in Nutraceutical Manufacturing are designed to meet critical training needs in the multi-billion dollar nutraceutical sector, which includes products such as dietary supplements and functional foods.
In the United States, the same strict GMP regulations that govern pharmaceutical manufacturers also apply to all companies that manufacture, package, label, or hold nutraceuticals or dietary supplements. A key requirement of these regulations (specified in 21 CFR Part 111) is for all personnel to be trained in the proper use of SOPs (Standard Operating Procedures) and completion of records.
Both e-Lessons are based on these regulations and are suitable for both ‘on-boarding’ of new hires and as refresher training material for existing employees.
Accessed via the Internet or your company’s intranet/LMS, each e-Lesson is a rich multimedia learning experience that combines text, audio, graphics and animations to transfer critical knowledge in an engaging and interactive way.