What training do you recommend?

[Kary13]

Hello all!

In the past few months, I have used information from this website quite a lot and I sure appreciate every advice I find here... So I am asking for your help again!!!

I have been working in QA field for 5 months now, in a small business dealing with medical device. My background, prior to working for this company, is mainly in software development (I hold a Bac in Electrical engineering) in a highly regulated environment, though different from medical. With the help of a consultant, I am implementating a QMS within the company and we are also going for CE marking, FDA 510k clearance and MDL license.

My problem: Although I am learning a lot from the consultant, I would like to get properly trained in order to do my job the best way possible. Also, the consultant will not always be there so I need to be further confident about how to handle certain situation. I looked for different training, but there are so many available that I am a bit lost...

My question: Which training do you value the most? Which ones do you think are essentials and which one would be "nice-to-have" trainings?

Thanks a lot for your help!

[Phil Fields]

Kary13,
I would suggest going to www.aami.org and review their available training. I have taken the Quality System Requirements and Industry Practice training.

The training was interactive and also had FDA representatives as some of the speakers.

Phil

[Randy]

What do you want to be doing 10 years from now?

If you get trained within a narrow focus range you limit your options, but if go a bit broad based there will be many more paths open to you.

Think of yourself as a product sitting on a shelf in the store. Your education/training is part of the packaging. Package yourself for too small of a market segment and you'll wind up in the discount isle because the store needs the space for products that sell.

[Beachwalker]

Although I am admittedly biased because I am a trainer and HR writer, I would caution you not to limit your training to technical aspects of your career. Make sure you round out your formal learning with things like work/life balance, Covey or Covey-like organizational tool training, goal setting, interpersonal skills training and other "fuzzy" training choices. No matter which field you're in, you will be a better doctor/lawyer/engineer/fill-in-the-blank if you're a better organized, more empathetic person.

I've seen tooooo many technically skilled people who cannot work well because they have ONLY the technical skills and no life skills.

[pschnoor9]

Hello Kary13:

The first three responses are all excellent, and should be taken together to realize a truly excellent path. I would add (elaborate) that from your description you are not looking at a "quickie" solution.

There are a few universities that offer an advanced degree in Regulatory Affairs (the degree builds on other science degrees - mainly engineering). The "opening" classes for these are exceptional for the overview and high level understanding of what you will be facing (and responsible for) as a Regulatory Affairs professional.

I would start by becoming a member of organizations such as American Society for Quality (ASQ) and the Regulatory Affairs Professional Society (RAPS). These organizations are very helpful when looking for educational opportunities (as well as professional support!). Searching RAPS for colleges that offer Regulatory Affairs programs makes the process of finding a program to fit you much easier.

Good luck with your quest for enrichment and enlightenment.



Patricia