Tag Archives: analytical chemistry

20th Anniversary

I reached another significant milestone this year. No not a 20th wedding or work anniversary; I actually achieved both of those many years ago. No this year, 2017, marked the twentieth year that I have been teaching a professional development course in the pharmaceutical industry on Analytical Method Validation. This 3-day course covers the development process drug manufacturers must complete in order to prove that their methods of analysis for testing drugs are acceptable to the Food & Drug Administration (FDA).

Several years ago, I wrote a series of blog posts about how I got started teaching as a part-time endeavor. At that time, our course—I teach it with another pharmaceutical professional—had reached a 15-year milestone. Just this past October, we actually presented the course for the 100th time, another significant achievement. Over those 20 years and 100 presentations, we have taught over 2,600 participants in what has turned out to be a very popular topic due in no large part to the lack of specific guidance from FDA.

This particular topic is one that I have always enjoyed and one I started out doing as a part of my job function over three and a half decades ago. Over the years, I have developed an approach to perform this function that mirrored the one developed by the person I teach with and so laid the groundwork for our co-development of this course.

One of the things that I have discovered about myself in presenting this course is that I really enjoy teaching. To me, it does not seem like work but rather more like play and given it is a topic I am very interested in, one I thoroughly enjoy talking about as well. Also, given the number of times we have presented it, I know the course material so well that there is no preparation time required; I just show up, load my PowerPoint slides, and start talking. We do occasionally make updates to the course to keep current with changing requirements in the industry but this is never an onerous task.

Because my employer does not pay me to teach this course, I have to take vacation time from work in order to participate. Given that I am “on vacation” when teaching, I share this concept with course participants by including vacation slides interspersed among my technical slides. These vacation slides are typically from locations where we teach and coincidently where I try to add in some non-teaching vacation time as well. And my opening vacation slide is from my favorite place in the world—Montreat—where I vacationed for many years growing up.

Assembly Inn overlooking Lake Susan

As I mentioned in that previous blog post, this course has allowed me to see the world. In addition to the designated US locations where we teach (San Francisco, Chicago, and New Brunswick, NJ), I have been to Amsterdam 29 times and Europe a total of 44 times. So while I have used much of my vacation time over the years to teach, it has been in some very interesting locales where I experienced some unique sites.

Aquaduct of Caesarea (Israel)

In that post, I also predicted that by the time I retired, I should be a million-miler frequent flyer with all the travel associated with teaching. Well I haven’t quite reached that level yet with just 728,517 miles so far. But that just means one more milestone to achieve in retirement.

When I wrote those posts several years ago, I also indicated that I wanted to develop a second course to teach. I have since done that, developing a course on Stability requirements in the pharmaceutical industry, another technical development activity drug manufacturers must complete in order to satisfy FDA requirements for establishing the expiration of a product. I have now taught that course six times since launching it in 2015.

And just this year, my brother developed a course that he began teaching for the same organization on another pharmaceutical topic. Next year, we have been able to schedule our respective courses back-to-back so in addition to our teaching, we will get to see each other, something that doesn’t happen that often given the many miles between our homes.

So as we near the end of this year and prepare to ring in a new year, I take pause to celebrate this teaching milestone. And if you happen to work in the pharmaceutical industry and need this type of training in the future, then maybe our paths will cross and you will join me in our vacation time together talking about one of these two exciting topics, at least exciting to me. Hopefully my enthusiasm for the subject will spill over and infect you as well.

How I Got Started Teaching – 401 (prerequisite 301)

In our second year–the first full year of teaching–the course took off in popularity as we taught nine separate times.  Five of these courses were in Europe and I remember moving up in frequent flyer status so quickly, that I was achieving the next level even before I received the credentials in the mail for the previous level.   Separate trips to Amsterdam, Rotterdam, Denmark, Finland and Switzerland in addition to the other four domestic locations allowed me to really rack up the frequent flyer miles.  I remember my boss coming to me at the end of the year to say that I was gone from work so often, that people were beginning to ask if I had left the company.  His suggestion was to teach less the next year, which I did—only seven times in 1999.  These courses also included European trips to Amsterdam (twice), Portugal, and Israel.


While I often comment that M and I have seen the world together, a downside of using my vacation time to teach this course is that it has limited the time I had to take “real vacations” with my family.  Fortunately my wife has been able to travel with me on many of the trips and occasionally my children have been able to come along as well.  Admittedly teaching involved work for me but fortunately there was always a way to include a few days of vacation on the front or back end of the course.  While I was sacrificing some of my vacation to “work,” I was teaching a topic I loved and was very passionate about and after teaching it so many times, was easy to do without any preparation.


This year, I made it to Asia for the first time when I was asked to teach in Turkey.  For this course, I would be the only lecturer but I didn’t anticipate this would be a problem since M and I had each taught alone previously due to scheduling conflicts.  But several factors resulted in this being one of the hardest times teaching.

First, I came down sick with a sinus infection two days before we left which left me symptomatic the entire trip.  Second, it took us so long to get there; I barely had a full day before teaching which with being sick, made the jet lag even more severe.  Then third, I found out once there that a translator would translate my comments into Turkish after I spoke.  This made it very difficult to keep up the flow of the class especially since I had already been asked to compress the three-day course into two days.  When it was over, I told my wife if that had been what it was like to teach this course when I first started many years ago, that I would have really had second thoughts about continuing.


In 2012, we celebrated our 15th year of teaching the course.  Over those years, we have taught the course over 80 times to almost 2,400 participants.  In addition, these trips allowed me to travel to Europe 39 times.  While these trips may not have achieved the variety of destinations my mother- and father-in-law had traveled to, it certainly met or exceeded the number of European trips they had taken.  And I had not had to wait until retirement to begin my travels.

As I move towards retirement, I think of the additional time I will have to teach.  No longer will I have to decline teaching opportunities since I will no longer be limited by a finite number of vacation days.  I also plan to develop a second course that will afford me even more travel and I have begun to take steps to lay the groundwork for that course.


By the time I do retire, I will have racked up over a million frequent flyer miles and will be able to consider myself an experienced international traveler.  I will have definitely answered my question from so many years ago—that no I won’t have to wait until I retire to be able to travel internationally.  I will have already done so and future travel in retirement will just add richness to the experiences I have already enjoyed.

How I Got Started Teaching – 301 (prerequisite 201)

A few years later, the British gentleman I had lectured for asked me to present at two more national meetings, one in New Jersey and one in Puerto Rico.  The political climate was more favorable, so I got the green light for both.


The timing of my presentation was advantageous.  A controversy regarding my lecture topic had been brewing in the industry.  Now I had a chance to share my thoughts on resolving the issues.

I gave my presentations and they went well, but one moment when lecturing in Puerto Rico was tense for me.  Excited about sharing my ideas, I was eager to get started.  With just five minutes left before my talk in a ballroom set up to hold 100 people, only three seats were occupied.  I looked over at the British gentleman who appeared unconerned.  When I asked him about it, he smiled and said, “oh yea, you’ve never been to Puerto Rico.  Their favorite expression here is ‘Mañana’ (Spanish for ‘tomorrow’).  We won’t start for at least another 20 minutes.”


Later that year, I got a call from the organization that the British gentleman (Dr. S.) taught for.  They said Dr. S. had recommended me for developing a three-day course on the topic that I had lectured on with him.  What, take a two hour version of a 20 minute talk and turn it into a three day course?  I had to really think about that.

I called Dr. S. and thanked him for the recommendation but asked him what I should do.  He said don’t try to do it alone – get someone who thinks like you to help.  I hung up and began to wrestle with this.  I knew I wanted to do the course but I didn’t know whom I could get to help me teach it.  I thought about people I had worked with before and other previous contacts in the industry but couldn’t think of anyone.  Then I remembered the person (M) who had lectured after me at the FDA conference.  I wondered if I could find his contact information.

I don’t know how I was able to find his number but I called M and he was very interested in working together to develop and teach the course.  We then set up some time when we could talk at greater length about how we should structure the course.


Our first step was to come up with an outline for the course and submit it as a proposal to the organization.  We wanted to develop a course that covered the entire subject from beginning to end.  We came up with the major topics that needed to be included and were amazed that we both quickly agreed what was important to include.  M made a really helpful suggestion about including a couple of workshops in the course so it wouldn’t be just lectures.  I suggested a Q&A session as a part of the course so participants could ask any question about the subject.  We put together the course outline, submitted it and then waited for the response.

The response we got was positive and we were asked to put together the course.  It was to be divided into twelve one and one half hour lectures over three days.  Once we broke down the topics over the three days, we decided who would work on each.  With that decided, we each began preparing 35 mm slides.  I knew preparing the course would take me away from my family so I began going into work very early on Sunday morning and working just until noon so as to minimize my time away from home.  I don’t recall how many weekends I did this but it probably took about six months to put all of the slides together.


The first time we were scheduled to teach the class was in July 1997.  The maximum class size of 46 filled up quickly.  In fact someone who had previously worked with me and had moved onto another company called me directly to ask if I would let him in the class since he needed the course prior to an FDA inspection.  So our first presentation had 47 participants and went very well.  We taught the course a second time that year in the fall for an individual company which also went well.

How I Got Started Teaching – 201 (prerequisite 101)

My association with the British gentleman teaching as a part of his course led to several more lectures over the next two years along with a second trip to Amsterdam.  All of a sudden this guy (me) that didn’t even want to make a 20-minute talk was on the lecture circuit speaking multiple times a year.  I was getting to really enjoy this extra activity.


Not long after getting started teaching, I received an invitation from the American Chemical Society (ACS) to give a talk at their national meeting in San Diego.  Their request was to present a paper about a couple of articles I had gotten published on the topic I had been teaching about.  I was starting to sense that I was stepping into the big league.  With my boss’s approval, I accepted and submitted an abstract for the talk.


Unfortunately just as the saying goes, all good things must come to an end; the political environment at work soured.  My boss came to tell me that I wouldn’t be able to give the ACS talk and that I would have to discontinue teaching with the British gentleman.  My time on the lecture tour had been short-circuited.  My next steps were to notify the ACS and the British gentleman that I was not going to be able to go forward with future lectures.


A few months later, my boss was sitting in my office talking about what had been going on at work that had caused the political difficulties.  He said that in spite of the fact that the ACS was a nationally recognized organization, he still couldn’t overcome the political climate.  On the other hand, he said if the FDA were to ask me to speak, that that would probably be fine.


As my boss finished saying that, my phone rang.  It was the FDA.  The caller had read the abstract of my talk from the ACS meeting and wanted me to present it at the FDA Science Forum in Washington.  I couldn’t have choreographed the timing of that call any better even if I’d spent months to plan it.  I had to explain that I actually hadn’t even written the talk but that I looked forward to writing it.  I thanked the gentleman for the opportunity and told him I would get back with him.  I hung up the phone and explained to my boss the other half of the conversation he had just heard.  We were both dumbfounded for several reasons, not the least of which was how FDA even got my telephone number.


My trip to Washington the fall of 1994 was less eventful than my first lecture trip to Chicago.  I didn’t have any flight trouble as I did before but I did have to laugh when the FDA sent me my airline reservation information and there was a note at the bottom that stated if I was a government employee, that any frequent flier miles I earned were the property of the US government.  While the FDA covered my travel expenses, they didn’t cover the cost of preparation of slides (this was a time before PowerPoint).  At most national meetings, the expectation was to come prepared with 35-millimeter slides.  At many of these same meetings, I had seen FDA use overhead transparencies so knowing that was what FDA had used, I just prepared those.  That was not what they expected.


Since I was on an elevated podium and the projector was on the floor, I had to ask someone from the FDA to turn my black and white overheads.  Well I might not have had to sweat the flight getting there, but I was sweating now.  I was in front of probably 100 FDA regulators and I was going to teach them how they should regulate us—with overheads.  Knowing that I would be nervous speaking to the FDA, I had typed out my entire talk.  I still have it today but I don’t think I could go back and re-read it, as it would make me nervous all over again.

I can’t tell you how I did; I can only tell you that I got through it.  Following me was another industry person (with slides) who spoke on another aspect of this same topic.  I was glad to hear that he had a lot of the same thoughts as I did about how our industry should be regulated.  Over lunch, I struck up a conversation with him about how I hadn’t been able to give my talk in San Diego but then had the opportunity to write it for the FDA.  His story was equally interesting.  His boss was supposed to give a talk in San Diego but had backed out at the last minute so he had had to give it.  We both thought what a curious turn of events, that I was supposed to go to San Diego but couldn’t and he wasn’t supposed to go but did.  And thanks to someone within FDA reading the abstract of both our ACS talks, we were now presenting to the FDA.


How I Got Started Teaching – 101

As I think about the many years I have been teaching professional development courses, I wonder if the desire to teach is hidden in my family’s genes.  For it was in the field of chemistry, not teaching that I had pursued undergraduate and graduate degrees.  And it was these degrees that have been the foundation for a career in analytical chemistry that I have enjoyed for over 30 years.


It is interesting to note that in one way or another, all three of my siblings are also involved in teaching even though that was not their original field of study.  One sister went from retail management into teaching.  Another sister went from religious studies to teaching quilting and is now an art professor.  And my brother who is also a chemist is literally trying to teach the world how to harmonize standards in the research industry that he and I both happen to work in.  Each of us over our lifetimes has taken different circuitous routes to end up either full time or part time in teaching.

My path to teaching started in 1992 but also involved a desire to travel.  Being fairly young in my career, most of my business travel had been to the same few cities on the east coast where our industry is concentrated.


I longed to travel internationally, as my in-laws were enjoying at that time.  When I heard the stories and saw the pictures of their travels to Europe, I wondered if I too would have to wait until retirement to see the places I dreamed about.  But it was no less on one of these business trips to Philadelphia where the story begins to my teaching and my international travel.


It was in the summer of 1992 that I was asked by my boss to make a 20-minute presentation at a national meeting about an analytical topic I had been working with for about 10 years.  For the meeting agenda, I would give the industry perspective on this topic and the Food & Drug Administration (FDA) would give their perspective followed by a 20 minute discussion panel where the two of us would answer questions from the participants.  I must admit that I am an introvert and didn’t really want to do this.  And besides, this would be my first presentation side-by-side with the regulatory authority of our industry, an activity that can be intimidating at times.  However, my boss “convinced” me that it would be both in my best interest and that of our company for me to make this presentation and so I agreed.

My first thought was how could I even talk about this topic for 20 minutes?  I came up with what I thought should be presented from an industry perspective and put some slides together.  Before I could even go through them to see how long it was, I found out that the FDA had canceled and I should make a 40-minute presentation.  So I added more slides.


The day came for the meeting and I walked in with what I thought was a 40- minute presentation.  Turns out, I had a lot more to say on the topic.  I took the entire hour, which didn’t even leave time for questions.  But the presentation was well received.  After it was over, a British gentleman came up to speak to me about the presentation.  He complimented me on my organization of the topic and my depth of knowledge of the subject.  He went on to say that my Southern accent was easy to understand.  I remember thinking, “What accent?  You’re the one with the accent.”  He then asked me if I would be interested in giving an hour and a half lecture on this subject as a part of a weeklong course he taught.  And to sweeten the offer, he indicated that one of the lectures would be in Amsterdam.  My first thought was could I talk on this subject for an hour and a half?  My second thought was “Wow, Amsterdam, international travel.”  I told the gentleman I would have to get back with him on the offer knowing I would have to get approval from work to do this.

Back in Memphis, I told my boss about the offer and he immediately thought it was great.  Again, he said it would be good for me and good for our company.  How could I refuse, especially with an international trip in the offing?

So back to the computer I went to prepare more slides.


The first time I was to teach was the following spring in Chicago.  My lecture was scheduled for 3:00 PM and so to save money, I planned to fly up the morning of the day I was to lecture since it was only a one and a half hour flight.  However, when I got to the airport, I found out my flight had been canceled.  I scrambled to make alternate arrangements and managed to land in Chicago only a few hours late.  However getting to Chicago was only the first of my challenges as the taxi driver got lost trying to find the hotel (this was before the day of GPS).  Finally, I managed to get to the course location at 1:00 PM just as lunch was ending.  When it was my time to present, I again found I had prepared too much material as my 1.5-hour lecture turned into a 2.25-hour lecture.  Fortunately I could go over and in the course evaluations, my lecture was well received.


The second time I was to lecture on this topic was in June and this course was to be in Amsterdam.  I remember thinking as I looked out of the window of the plane before we landed that soon I would be stepping foot on another continent, my first international trip.  Certainly not of the significance of stepping on the moon for the first time but for someone who had never even been to Canada or Mexico, still a momentous occasion.  Being jet lagged from the overnight flight, I fortunately had a day to recover before I had to lecture which gave me time to do some site seeing.  Exploring in a foreign country for the first time when you don’t speak the local language can be daunting but in Amsterdam, almost everyone can speak English.  Both the sight seeing and the lecture were a success.