ISO 22716 - GMP Training for GMP trainer

[nikiverse]

Hello,

I was doing a "pre-audit" with one of our customers. And they asked if we do GMP Training. And I was like Yes, I lead the GMP Traning. And then he basically asks, "who trained you?" And I was like ... uhhhh. He was looking for some type of certificate or training body. So if you present and lead the GMP training at your company, who trained you? Is there an organization that offers GMP training that's pretty respected ... can you get it through ISO or through ASQ? How do people answer this question? I'm sure saying the ISO standard, Google, and Elsmar discussion forums are not appropriate for my GMP Training

 

[pziemlewicz]

My preferred source is Trainings for FDA Compliance - Webinars, Seminars on Latest Regulations -- they offer both in-person and web-based. A handful of other respected organizations offer free 1-hr webinars, but I treat these more like continuing education (if you want to PM, I'm happy to share the list that I follow).

Conversely, MDR has an outline for PRRC requirements. Listed needs for Person Responsible for Regulatory Compliance offer both an education and experience pathway. If the person performing the training meets the requirements listed, I would argue that they are qualified.

 

[nikiverse]

A handful of other respected organizations offer free 1-hr webinars, but I treat these more like continuing education (if you want to PM, I'm happy to share the list that I follow).

Conversely, MDR has an outline for PRRC requirements. Listed needs for Person Responsible for Regulatory Compliance offer both an education and experience pathway. If the person performing the training meets the requirements listed, I would argue that they are qualified.

Even though I've lurked here for years, I don't have enough posts to send a PM, but I would totally appreciate some resources if you wouldnt mind sending me a PM!