GMP Regs: Interpreting Between the Lines

It is rare to be writing about (literally) the first person you met in industry-almost 20 years ago, and he is STILL serving in the role as a teacher, author and mentor.

Back in the early 90's, I owned the Institute of Validation Technology, and was hosting my first industry conference on "Packaging Validation." I was fortunate enough to meet John Stromp, then working for SmithKline Beecham. I learned that he had a background as a teacher and instructional designer, and I asked him to serve as an instructor for an upcoming conference. He quickly agreed, and over the years, he served as an instructor and author on numerous topics ranging from auditing, FDA and DEA inspections, writing effective protocols, to interpreting GMP regulations.

His experience as a teacher and instructional designer enabled him to successfully execute his "3 Slides-3 Hours" trademark training presentations, that is; he would only use a few powerpoint slides, throughout, yet was able to engage attendees through discussing his experiences and practical thoughts on his topics in easy to understand concepts: always focusing on the fundamentals. For example, he was a proponent of keeping SOPs to a minimum in order to avoid confusion.

Or, if he was discussing GMP regulations, he taught with a "here's what the regulation states, but here's what it means" style.

When we launched enKap in 2009, John was a natural choice to author a continuing series in our FDA Compliance Digest on all of the Subparts that comprise GMP regulations, as well as serving as an instructor for our upcoming training workshop May 12-13:

➢Introduction to Good Manufacturing Practice: Meeting FDA Requirements - for brochure click here

For new employees, this training workshop is an excellent choice to begin learning the fundamentals of GMP regulations, building their foundation of regulatory compliance and applying this knowledge to their job responsibilities.

He also recently conducted a complimentary webinar on "Meeting FDA Requirements: Subpart D - Equipment" here are his slides - complimentary:

➢Subpart D - Equipment Webinar PowerPoint Slides - click here

➢For a complete list of enKap events - click here

➢For more complimentary content click here- click here

Until Next Time

Glenn