FDA: Next generation GMPs -- new training

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:

• Conflicting opinions among auditors, certifiers, and FDA investigators lead to confusion​, 483s and, sometimes, a warning letter.​
• Staff turnover and quality positions often leave gaps and inadequately trained staff on the operations line.
• A basic lack of understanding of how FDA conducts inspections and how investigators are trained.
• This includes a failure to study the In​vestigations​ Operations Manual (IOM) and other FDA materials that are the “bible” for investigators.​ The IOM 2017 edition is over 500 pages long!​

UNPA, under the direction of Larisa Pavlick, VP, Global Regulatory & Compliance, and ​a ​former FDA investigator, has designed a new​-​generation GMP training course to achieve one key goal: to ​teach you​ to run your GMP and quality operations based on FDA’s inspection criteria and expectations.

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.​

Kind regards,

Loren Israelsen