Great Instructors and the Power of a SNICKERS

In Canadian Medical Device Regulations, CMDCAS, Training on November 13, 2012 at 3:57 am

I guess there are still some instructors out there that need to be reminded that we can all read the regulations on our own. We don’t need to pay $1,000+ per day in order to have someone read stuff for us. If that’s what you want, my 10-year old son is a fantastic reader. He’ll record anything you want, in any media format, for a much smaller dollar figure.

If you want to learn something that is worth at least as much as your investment of time and money, then you need to find an instructor that can teach effectively. There are four prerequisites for a great instructor:

1. The instructor must be an expert.

2. The instructor must inspire participation.

3. The instructor must provide practical examples for each student.

4. The instructor must get everyone’s attention–and keep it.

The most important determining factor of training effectiveness, however, occurs after the course is over.

You may have read my other posting with two songs by the lead singer of Pink Martini–China Forbes. However, China was unable to sing for a period of time and Storm Large was the guest singer that helped keep their tour going. Storm is larger than life and so passionate, but this performance is only one side of her personality…

When you are teaching quality assurance and regulatory affairs, you must develop your ability to inspire and engage students to Olympic medalist proportions. “Blah, blah, blah…” and “Death by PowerPoint” will get you fired. Don’t read your slides, don’t turn your back on the audience (or they’ll attack), and PLEASE don’t ever ask someone to read the definition of nonconformity out loud to the rest of the group. When I teach a class you demand my best. I’m six-foot, six inches tall and I have a loud booming voice. My mother has red hair and she was an opera singer. I’ve got the voice to fill any auditorium, and the stage presence to match. But if you even start to nod off in class, I may just have to throw a Snickers bar at you.

This is an essential tool for any instructor. It functions as a tool to prod sleeping students awake, is small enough to cause minimal injury when thrown, serves as an emergency food supply, and it’s gluten free.

If legal council recommends against using projectiles to encourage class participation, you might also consider one of my all-time genius ideas. I was scheduled for a 2-day course in Ottawa, but the day before I needed to perform an audit in Pennsylvania. Therefore, my flight was the last flight into Ottawa–arriving at approximately 1 am. My flight was delayed more than an hour and the person in front of me was trying to smuggle an extra carton of smokes into the country. Just before 4 am my taxi arrived at the Albert at Bay Suite Hotel. Class started at 8 am. I made it to class on time, and excessive consumption of several pots of black coffee helped get me to lunch. Then my legs started getting a little wobbly. Fortunately, there was a convenience store next door that sold my favorite chocolate–the Dark Aero bar! After four of these monstrous organisms of cacao, and another pot of coffee, I could have listened to the lecture on Canadian Medical Device Regulations all night.

The closest chocolate companies have come to selling the body of Christ.

Hershey’s copied them, but the result was a mere shadow of the Nestle’s greatness. Canadian’s know how to make junk food, tell a joke and play hockey!

Despite the physical handicap of sleep deprivation, I still learned a ton from my course in Canada. Here’s why:

1. The instructors were experts. Both instructors were regulatory experts and Canadian. Both instructors taught this course twice a year for multiple years, and one of the instructors actually worked for Health Canada.

2. The instructors were blessed with the perfect audience that was hyper-motivated to pass the course. Everyone in the class worked for a Notified Body that had sponsored them to take the course. In order to stay employed and get a raise, I needed to pass that course. If I failed the exam, I had to absorb the cost to travel back to Ottawa and retake the course in February (BRRRR!).

3. Everyone has different experiences and therefore not every example makes sense to us. Therefore, instructors need to use practical examples that are actionable. In  this course, the instructors brought more than a dozen medical devices to the class. We studied the labeling and the intended use of each device. Even students from Japan, Europe and Australia were familiar with some of the products. This was critical, because we all needed to be able to identify incorrect Canadian labeling.

4. The greatest asset of all was the humor of the instructor from Health Canada. He was hilarious. He had everyone laughing at his jokes for the entire course. Most of the jokes were not funny enough for a stand-up routine, but this was a mandatory regulatory course on Canadian regulations. Who would even expect a chuckle.

Despite the strengths of these instructors, there is only one reason why I know the Canadian Medical Device Regulations (CMDR) as well as I do. I use them every single week.

Here are some examples of how I used the CMDR:

First, I had to audit 162 days for BSI in 2011. Ninety percent of those 162 days were for companies that required a Canadian Medical Device License. Therefore, I started auditing companies to the Canadian regulations immediately after the course.

Second, I was also consulting for companies at the same time I was auditing for BSI. Consulting clients hired me to prepare and submit Canadian Medical Device License Applications for them. I also had to revise and create new procedures specific to the Canadian regulations. I spent another 60+ days in 2011 doing consulting.

Finally, I was one of BSI’s instructors that taught the a regulatory comparison course that compared the regulations of the USA, Canada, Europe, Australia and Japan. Therefore, at least once a month I had a classroom of 6-20 people asking me challenging questions about how to interpret and apply the regulations from each of these countries to their products.

I used every bit of knowledge I learned in that course in Ottawa and I started using that knowledge immediately after the course. I had peers, superiors, clients and students challenging my knowledge of these topics every day. This is what makes you an expert.

If you need to learn something about Quality Assurance or Regulatory Affairs, a one-hour webinar is not enough. Reading a blog is not enough. Taking a 5-day class is not enough. Shadowing another more experienced person is not enough. In the end, all of the above will get you to barely competent!  If you want to learn, you need a great instructor. Then you need to use everything you learned at every opportunity for several years.

Some say, “If you can’t do, teach.”

I say, “Bring a SNICKERS bar and throw it at them for faking it.”

For those of you that are brave enough, Storm will perform an encore that shows you a little of the wild side that we all need to unleash from time to time (even us regulatory geeks). I think she might have had more than one candy bar before this performance.


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