Best practices for GMP training

[psyched1]

I am wondering about best practices for GMP training. I have stolen from every company with in our corporation however we still have findings throughout the facility. My latest approach is to have the supervisors do the training so as to ensure at least one group gets it.

I am thinking about changing the process to provide case studies as the test. Display GMP viloations then have the students higlight or circle the obvious violations. After they are completed we can have a discussion section.

What are other people using?

[ScottK]

Originally Posted by psyched1

I am wondering about best practices for GMP training. I have stolen from every company with in our corporation however we still have findings throughout the facility. My latest approach is to have the supervisors do the training so as to ensure at least one group gets it.

I am thinking about changing the process to provide case studies as the test. Display GMP viloations then have the students higlight or circle the obvious violations. After they are completed we can have a discussion section.

What are other people using?

I'm not doing GMP training anymore but I was with an FDA registered contract packager for a while and I would:

1) Get involvement by having a combined safety and GMP committtee so when they did safety audits they would also do GMP audits. 2/3 of the committee was production workers.
2) Give training to small groups in a conference room, not on the production floor.
3) Give a quiz after every training session, including hands-on how to properly change an entry on a quality record every time (our biggest recurring problem).
4) Take time to explain each violation AT THE TIME IS IS FOUND to the people working in the area.
5) Had a "General GMP Procedure" written in plain language for anyone to reference at any time.

It was pretty effective. While I was there we never got a 483 from the FDA and never lost points on the GMP portion of a customer audit.

[Vulekani]

i have had the same experiences but i found a way around it
- always have some food or candy or incentive to entice the people into involvement . This seems to work. Ask questions and if they answer well reward them openly.
- Always have a discussion 'ball'. We use that for every meeting and it is said a human mind absorbs more if they are playful with it
- believe me a test at the end wont help in any way.Observe them when they work and offer instant correction

i hope this makes sense

[Ajit Basrur]

Originally Posted by psyched1

I am wondering about best practices for GMP training. I have stolen from every company with in our corporation however we still have findings throughout the facility. My latest approach is to have the supervisors do the training so as to ensure at least one group gets it.

I am thinking about changing the process to provide case studies as the test. Display GMP viloations then have the students higlight or circle the obvious violations. After they are completed we can have a discussion section.

What are other people using?

I plan GMP trainings at different levels viz -

a. Training during induction
b. On the Job Training
c. Annual Refresher Training

Apart from these, regular classroom training is provided with an assessment to evaluate their understanding. You could also have videos as pictures speak thousand words and convey message faster

Then during routine inspection rounds, any discrepancy is pointed out and gets highlighted in the departmental meetings.

[Ajit Basrur]

Hi vulekani - welcome to the cove

Nice to see your participation and hope for more responses.

[QA-Man]

Consider the complexity of the processes for which training is required. Simplifying the process, when possible, can reduce the amount of training required and decrease the chance of mistakes.

Consider the education, culture, and language skills of your audience. Complex terminology might be a barrier to understanding or could be misunderstood.

Consider ways to make information more accessible. We combined our Device History Records (shop travelers) and Product Work Instructions. We put in many pictures as well. We then added the DHR/WI to the bill of materials so that its part of every kit.

For standard operating procedures we have open book exams and administer new exams when the procedures have significant changes.

To get key concepts accross (like our quality policy), we put the same question on every exam.