Seminars

A couple months ago I got talked into teaching seminars. Well, it was the culmination of further preceding months of discussion. Last Friday I did the first one, three days ago I did the second one, and yesterday I did the final third one. I think they went well. But I am awaiting mentally definitive feedback.

The seminar subject was the United States FDA’s “QMSR” proposed rules, which were announced in draft form last February and are intended to replace the current quality system rules that FDA requires medical device companies to follow in order to sell their products in the United States. The current rules have been in place in more or less their current form since 1996.

My seminar explained for Japanese companies what the proposed rules say, and what will change and not change from the current ones. (The main change is that after many years of harmonization work, FDA will largely incorporate by reference (basically adopt) most of the ISO 13485 standard that many other countries use to achieve the same regulation of medical device manufacturing.)

This is not a sexy subject. But the fact that you can be vaccinated with a needle and not have to worry about its sterility, for example, is sexy as hell, and is thanks to this kind of regulation. So I like being in the business and it is fulfilling to me while paying the bills.

The friend who talked me into doing seminars is one who has brought me some great work opportunities over the years. I nearly wrote him off when, many years ago, he farted in my car while we drove to a job site. But since then he has made up for it by farting money into my coffers.

He has also—and this is so so key—understood my distracted ways well enough to project-manage the work he brings so I get it done. It is a wonderful symbiosis, because he has vouched for my abilities to his clients or contacts, and cannot allow me to disappoint them, even though, sadly, on my own, I would statistically end up disappointing them. He either keeps the work progressing on a good cadence by setting up milestones for us to track, or he takes on the part of the work that I am clearly not going to get done. It is incredible to me that he could understand me well enough to do this but also see the value I bring that makes the said trouble worth it to him.

The one other thing he does that means the world is he tells me the value of the skills and knowledge I have. There are virtually no other consultants in Japan who are effortless in Japanese and English who can explain the FDA’s rules / interpretations and on-the-ground inspection techniques, and fearlessly communicate with FDA. I constantly sell myself short out of insecurity, and he pumps me back up with an objective viewpoint of what I bring. He also gets indignant and stops me when I consider compromising on price due to insecurity.

Wisely, my friend helped me to hurry up and advertise and execute the seminars before the end of the fiscal year for most Japanese companies, March 31. This way the seminar fees were a productive outlet for quality assurance departments to spend their remaining fiscal year budgets, lest they be reduced the next year. I was happy to place my self in that flow of funds in exchange for bringing real value to the clients.

The advertising was simply me sending an email to most of the companies I have done interpreting and consulting work for over the years. That so many responded was a really nice surprise. My friend said it was an unusual response for a seminar announced that suddenly, and that it spoke to the esteem my clients have for me. It was especially nice to get enrollments from the clients who have only previously used me for interpreting—I am always trying to tell them I can do more than interpret now, but sometimes they (understandably) just have me pigeonholed in that role.

I was awake until 3:00 AM the night before the first seminar working to finish the translation of the QMSR proposed rules into Japanese, and having my employee help double check how it read.

From 3:00 AM to game time I was finishing the slides. Predictably, preparing the materials was the homework part that I neglected to finish with a more reasonable buffer. But the content came out great—often when I procrastinate it is rooted in wanting to get it perfect.

The content came out fine, but I do not like Powerpoint and the fanciness of many slide decks I see. I am incapable of having anything except a white background and muted colors. The one complaint my friend had about the slides was the lack of any graphic elements. I need to overcome my dislike of those to make it more interesting.

Another insecurity that the experience taught me to shake is that of creating content in Japanese. I am supremely confident in speaking and reading and understanding the language, but not being born or educated here from an early age leaves me insecure about my written words. But I created the slides and let them stand. Perhaps there were small things that felt weird, but when I am clear-headed I let that be my style and stand by it. Maybe I bring people value by expressing things in a way they aren’t used to, although it is grammatically correct. My current decision is to own my written Japanese style and let things happen however they will.

The first day, I think I taught well, but there were predictable little problems. One was that everyone was shy. Doing a webinar on Zoom means that you speak toward a black screen with no visual or audio feedback. Questions, if they come, are typed by attendees into the Q&A box, and then answered. So I had to overcome a lack of what this seminar taught me is quite a crutch of mine—working the crowd by watching and responding to their faces and body language, and finding that person who looks at you and relying on them emotionally like the Rock of Gibraltar. But I overcame that. If I must regale a wall, I will. There were maybe seven questions the whole four hours. Not a lot.

On the second day, Zoom ran my battery down despite the MacBook being plugged in. I realized that the lower wattage plug works fine for usual work but does not charge enough to keep up when running hard for Zoom. When the MacBook reached 10% battery it began to slow down and cause interruptions in my voice for the attendees. Luckily they let me know through Q&A, but it was harrowing. Since it was 11:40 AM by then I called an early lunch break and solved the problem by using the high-wattage plug. I got a few more questions the second day.

The third day was golden. I was used to presenting in my setup, and had my screens and power supply set up to efficiently see my slide notes while maintaining a perfect connection. The only blemish was starting out talking on mute. Oh that basic pitfall, for which I have scorned many a presenter’s carelessness! But I got probably 20 solid questions and answered each with aplomb. That part, which I submit would have been the hardest for many presenters, was the only thing I had absolute confidence in. I know the material and the business. This was a confirmation of that and left me feeling nigh unto invincible.

As is the case when I am auditing or interpreting all day, I was unable to eat much lunch between the morning (10:00-12:00) and afternoon (13:00-15:00) sessions due to anxiety. Since I was in the comfort of my office, I did make and eat a little bowl of oatmeal using the already-boiling water burbling atop the kerosene stove.

I left the experience knowing this can be a reliable piece of my business going forward. It garnered 50,000 yen per attendee (40,000 yen for the second and further attendees from a given company), and I got a total of 30 attendees over the three sessions. There are many other subjects companies want their employees to understand better, including the basics of the current FDA QSR rules, the basics of FDA inspection preparation, and some other specific subjects like process validation.

My friend admonishes me to not get too enamored with teaching the seminars myself—he is taking over a small consulting firm and will have a staff of young instructors who can teach the seminars once they are fully developed by me, which will then make it passive income on my end. I have a hard time delegating and developing people to do what I do, so this will be great.

But I might also do some in-person seminars just to meet people and have after-seminar chats that lead to consulting work. This aspect was disappointingly impossible to achieve with Zoom. Renting a venue and going there etc. will be a pain, but probably worth it. The informal interactions are where I can win a lot of people over.

It was fun to teach something that I love to talk about. I am glad that my friend pushed me to do it. I am grateful to have added yet another life experience.