13485cert

How do you Learn New Regulations? Normal, Lazy or Strategically?

In Authorized Representative, CE Mark, CE Medical, Medical CE, Training on October 3, 2012 at 4:06 am

For those of you that want some background music while they read tonight, I offer you a doppio caffè macchiato this evening. The first shot is an amazing interpretation of the famous song “Somewhere Over the Rainbow”. As someone that has sung this song hundreds of times, I never expected to hear a version that I would like more than Judy Garland’s. Now I have. My favorite part of the song was when Stephan Braun is playing a cello like a guitar and Melody Gardot stops singing and starts to brush the snare drum—and I love her voice.

Last week I mentioned the draft EU regulations that were released, and I am still reading them. I am sure some of you have already finished at least one of the two regulations, but I am a slow reader. Sure I have skimmed the regulations, but I really need to read every word of the regulations several times before I have absorbed the bulk of the content. While I was reading during my lunch today, I was wondering how other regulatory experts learn new material. After all, there is nobody to take a course from yet and a one hour webinar is not enough.

Some people like to listen to books on tape during their morning ride, but I think the market might be a little small for medical device regulations. We could use technology to convert the PDF format into an eBook format that can be read electronically to us on our commute to work, but I learn Standards visually rather than verbally.

Last year I published a blog titled “Never Stop Learning.”

In that post, I presented a model for learning that I find helpful for explaining my philosophy for training people. The first step in my Learning Pyramid is to “Read and Understand.” I call this the “newbie” stage. That is the stage most of us are at right now for the draft EU regulations. The next stage of the Learning Pyramid is “Show and Tell”. A course or seminar related to the draft regulations would involve a training telling us about the draft regulations and showing us some PowerPoint slides to help us visualize the changes. I think the technical term for this type of torture is “Death by a Million PowerPoint Bullets.” If your instructor is thorough in their efforts to torture you, then you will conclude this training with a quiz to demonstrate training “effectiveness.”

If you are lucky, you will start using some of that new-found knowledge immediately after the course. If you just had your 400th birthday, as I did last week, then you might have a little trouble remembering all the details you “learned” in that training course in a matter of weeks. Now what can you do?

Look it up! Isn’t that what your teachers told you when you were growing up?

If you need to know what the proposed requirements are for Authorized Representative Agreements, you can use the search function in Adobe Reader to search for the word “agreement”. After just six clicks of the mouse you will find where this is mentioned in Article 10 of the draft. As you read Article 10, you will rejoice! Instead of the 17-page voluminous guidance document identified as MEDDEV 2.5/10 (released in January of 2012), we now have 144 words with just four simple minimum requirements. This is streamlined.

Over the next year or two I expect that most the regulatory experts will gradually work their way up the Learning Pyramid to the top of the third level. This is the point where we can now claim competency.

So how do you become an expert? In order to achieve the mighty title of “Guru” you must teach others. My blog from 2011 on learning explains how the action of teaching actually teaches the instructor as much as it teaches the student.

So what’s my point?

Don’t be normal:

  1. skim the draft regulations now
  2. take a course on the regulations in 2013
  3. start revising procedures and technical documentation in 2014
  4. start developing an in-house training course on the new regulations in 2015
  5. finish training all the employees in 2016

Definitely don’t be lazy:

  1. wait for the final approval of the regulations in 2014
  2. take a webinar on the new regulations in 2015
  3. get a nonconformity for noncompliance in 2016
  4. hire a consultant to fix your procedures in 2017
  5. start looking for a course on the regulations in 2018

Instead, be a leader and accelerate your training strategically:

  1. read and re-read the draft regulations now
  2. read blogs and discussion threads related to the draft regulations for the next couple of months
  3. take a webinar on the draft regulations this November 28th (mark your calendar)
  4. draft a plan for revising procedures in 2013 and updating technical documentation in 2014
  5. get management approval for a training course in 2013 and resources to update procedures as per your plan
  6. take a course on the draft regulations in the first quarter of 2013; you should have quite a few questions now that you have a plan and resources
  7. make adjustments to your plan and execute it on-schedule
  8. create a training program for the company just prior to final approval in late 2013
  9. make revisions to the procedures based upon feedback from trainees in your in-house course
  10. develop a detailed team plan for updating the technical documentation
  11. retraining everyone and review the updating plan
  12. make updates to technical documentation 2014 as a team
  13. be one of the first companies to get a certificate to the new regulations in 2015

As I was writing my response to a request for additional information today, I was listening to one of my Pandora stations and one of my newest favorite singers was singing “Worrisome Heart.” Her soothing voice echoed in my head all the way home. I drive through 75 miles of beautiful countryside like my picture below, and now the autumn foliage is at its peak.

Typical Scenery on My Daily Commute

When I sat down to write my blog tonight, I decided to hunt for one of her recordings on YouTube for my background entertainment. Instead I decided to pick a double shot. For the second shot, I have selected one of the more popular videos by Melody Gardot: “Baby I’m a Fool.” This was the first time I have seen her play the guitar, because I have only listened to her on Pandora. The song has more of a country/blues sound to it than most of her other music, but I encourage you to listen to more of her music. Follow my rule…”A double shot is never enough.”

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