Dear UNPA Colleague,
GMP compliance statistics published by FDA show a stubbornly high rate of violations – some minor, some major.
Most serious DS manufacturers want and need a clean inspection with no Form FDA 483-Inspectional Observations. They also want satisfied customers, and they wish to avoid unwanted publicity, while running an efficient and profitable operation.
So, why do these common violations persist? Several reasons:
The only way to do this is to be taught by a veteran FDA GMP investigator. See Hank Schultz’ article in NutraIngredients-USA.com featuring his interview with Larisa on this topic.
On top of this, FDA has just announced it is reorganizing how it will conduct inspections – no longer based on geography but based on subject matter expertise. In the future, you will likely be visited by a different investigator with specific DS GMP training.
If your investigator is ramping up, it’s time you should, too.
So, we invite you to join Larisa on June 27-28 in very convenient Provo, Utah, for an in-depth two-day training that will take you through each step of the process, including an introduction to compliance with new FSMA requirements. Attendees will receive a certificate of training that meets FDA’s requirements for demonstration of proper GMP training and education.
Finally, please watch this short video from Larisa, who provides a first-hand explanation of course details.
We are pleased to offer a 20% discount if you reserve your seat by Thursday, June 8 (extended from the previous June 5 date). For additional details and to register, please see the complete training agenda here. Or, please call one of our staff -- Kira or Mika, at 801.474.2572.