Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:

    • Where do fashionable ghosts go to shop? Bootiques!
    • Why don't skeletons like parties? They have no body to dance with!
    • What do you get when you divide the circumference of a jack-o-lantern by its diameter? Pumpkin Pi!

He he...back to business...Recently, I've been thinking a lot about training. It's a topic that usually conjures up some wincing and moaning from most of the clients I've worked with, mostly because training consists of a laundry list of procedures and work instructions that you need to read through in order to be considered trained. This type of training is a necessary thing to keep a Quality System up and running like a well-oiled machine.

However, the other side of training is arguably a bit more exciting. Learning about new developments with the FDA, learning how to implement the regulations to fit your company, learning a subject that's new and exciting to you. Training doesn't have to be sitting down and just reading a procedure, it can be interactive, and research based. I wanted to share some resources and tools I've used to keep abreast of regulatory changes, and also some that I have yet to try out.

      • CDRH Learn - FDA has a webpage dedicated to continuing education in regulations. They have a whole list of online courses which can help to answer some of your general questions about medical device regulation in the US.
      • Webinars - Emergo Group has some really great one-hour free webinars on topics ranging from international registrations to mobile medical applications. They are usually very focused and informative presentations, and they provide access to the slides and webinar after the session is over.
      • Professional Societies - RAPS, AdvaMed, and AAMI are a just a few of the large medical device associations that you can join. They have ample opportunities for collaborating and training with other professionals.
      • Conferences - Earlier this year, I attended the MedCon conference in Cincinnati, OH. I was able to pick from a pretty wide array of sessions to attend, but one of the best things about MedCon was the high caliber speakers that they brought in. Current CDRH directors, ex-FDA experts, BSI representatives, industry CEO's all gave great presentations with interesting perspectives and insight. They certainly weren't afraid to talk about some controversial topics, either.
      • Books - "Mastering and Managing the FDA Maze" is a really good book to have on hand and it provides guidelines for how to achieve compliance with the regulations. Also, I really need to get myself one of those 21 CFR handbooks!
      • Newsletters - My favorite newsletter is Qmed Daily. It arrives in my inbox at 3:30 in the morning every weekday (I hate when I forget to put my phone on silent!). It has headlines about recent approvals, mergers and acquisitions, industry reports, recalls, etc. The list goes on. I can usually find a few articles each day that peak my interest.

I want to hear your ideas! What resources do you use to keep up in the industry? What is the best training course you have ever taken? What is worth our valuable time?

- Sherri

Image Credit: Ann Larie Valentine on Flikr

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