Assumptions Disciplines and Rainbow Sprinkles - GMP Training Advice from an Industry Expert

25 years ago, I didn’t choose to become a GMP Trainer.? I was TOLD to become a GMP Trainer.? And at that time, I was informed I was good at training. But I didn’t really know what it meant to be a trainer let alone design a defendable GMP Training Program.? I mean…what was a TNA (Training Needs Analysis).? And you mean to tell me Adult Learning is different than Academic Learning?? I knew what I did know.? I also knew what I didn’t know.? And when you know what you don’t know…where do you go to know those things???? Despite so many amazing programs in the industry today, I realize that some of these questions are still not that easy to answer let alone execute.? So what advice can I offer to someone new to the GMP Training Arena or maybe add to someone’s existing GMP Training knowledge?? What do Assumptions, Disciplines & Rainbow Sprinkles have to do with GMP Training?

?Let’s start with Assumptions.? I mean…people think they know what it means to work in a GMP Training Department.? You train people…right?? Well yes!? We do!? It’s the best part of the job!? Taking someone and filling up their brain with all kinds of new knowledge!? It’s the most rewarding experience.? Sadly, most of the “on the job” training is completed by area Subject Matter Experts (SMEs) so we only get to train on the basic new hire training.? But GMP Training Departments are responsible for more than just training people.? We work with the departments to ensure employee curricula for certain roles is always up to date.? We conduct mini assessments to see if employees are assigned the correct curricula for the job(s) they are performing and they are fully qualified on the role prior to performing the job independent of trainer assistance.? And speaking of trainers, are your trainers qualified?? How do you qualify your trainers?? What skills do you require for someone to become a trainer.? Do you have enough trainers and qualified (trained) staff to perform each role as suggested in the regulations?? All this on top of ensuring your site LMS (Learning Management System) is working as intended and employees’ know how to check their qualification status prior to performing a role/job prior to executing it EACH DAY!

?So with this I will delve into Disciplines.? How important is GMP Training compared to all the other tasks an employee has to perform each day?? Does your quality culture put an emphasis on just getting the job done or does it mandate it get done compliantly?? Does your company make time for GMP training?? I know how it is.? You got stuck in traffic on the way to work after a 2-week holiday and now you’re running late to get into the lab.? You know you should check your LMS to see if anything changed while you were out but they can’t start work without you and you still need to change into company authorized gear and get your head on straight.? You don’t have time to turn on your computer let alone check your qualification status.? And if anything changed your coworkers would tell you right?? WRONG!? This is where you need to stop and do what is right.? Even if it means taking a few extra minutes to do it.? What if a document was made effective during your holiday that will impact the role you play in the lab?? Will the change impact customer safety if not executed properly?? You know what you need to do but…can you do what is right even if it means setting everyone back?? Is the quality culture supportive of this or is the emphasis on just getting it done?? Does your company allow for Rainbow Sprinkles?

?So what is Rainbow Sprinkles?? This was a term dubbed by someone I adored and admired even after she left this earth in September 2017 due to cancer.? It was a term I will now pass along to you in honor of Dr. Jane Huffman.? Rainbow Sprinkles are when you know what the right thing to do is…but you have an internal conflict doing it or not doing it.? You see Dr. Huffman shared that there are times you try and break the rules.? You break the rules and hope you don’t get caught.? And you only think to break the rules when things get rough.? The experiment didn’t go your way for the one-thousandth time.? You said you checked the temperature on the incubator and recorded it but you actually didn’t because you wanted to leave work on time to go out with your friends.? You know you should check your qualification status before going into the lab but the traffic set you back and everyone is losing patience waiting for YOU!? And we all have Rainbow Sprinkles Moments. ALL OF US!? Most of the time we do the right things.? Sometimes we make mistakes.? Thank goodness for good quality management and review staff who catch these things prior to releasing product…right?? I mean they don’t have Rainbow Sprinkle Moments…do they?

?So when I started this blog, you probably thought I was going to give you all the answers and not more questions.? You probably thought I’d share the difference between adult and academic learning or how to set up a trainer qualification program.? Maybe one day I will!? But I will leave you on this note.

?Don’t ASSUME you know someone’s job unless you live a day, a week, neigh a month in their shoes.

Working in a GMP environment takes tremendous DISCIPLINE!? So if you don’t think you can handle being watched, checked and monitored often, this may not be the job for you.

And we watch, check and monitor you often to ensure we find the RAINBOW SPRINKLES and reel you back for the safety of our patients and our product.

?RAINBOW SPRINKLES aren’t bad.? They just remind us that humans are still a key component in the realization of a drug product.? It’s the RAINBOW SPRINKLES that show us the vulnerabilities of our systems.? So in a sense…everything works better because of the RAINBOW SPRINKLES.