Which is better - hiring a consultant to come and conduct an onsite workshop for my team or sending folks out to various third-party classes and industry conferences? Well, to paraphrase the FDA, it depends.
There are three typical considerations: cost, time, and customization. Some folks add "networking" and while I think there is truth to this, valuable networking is often outside the scope of your control. The person you send to the conference or class could be rather introverted, or the other attendees are not that interested, and so on. Thus, in terms of weighing the considerations, I don't add "networking," and instead add "expert advice specific to me."
Any measure of return on investment (ROI) has to address all four of these - and especially so for FDA compliance training or FDA quality systems training wherein cost control is a simple business reality. So let's look at each in turn, and use this to help make the determination.
The cost of training - whether an internal workshop or sending a team to external training - boils down to the following:
- Per attendee registration fee
- Per attendee travel
- Per attendee training material
All things being equal, if we treat the trainer(s) as an "attendee" then the cost of an inhouse workshop is always cheaper than the cost of sending a team to an external activity.
Assume a team of 10 and 1 trainer.
To send the team out will require 10 registration fees, 10 travel expense sets, and 10 sets of training material.
To bring the trainer internally will require 1 "registration fee" (workshop cost) that may be equal to the cost of 10 different registrations, so we should expect only a small savings here (if the registration fee is $500 per person and the internal workshop is $5,000, it's equal). The 10 sets of training material will still have to be purchased, so no savings here. But savings does come from reducing travel from 10 people down to 1. Unfortunately, for many companies, this comes out of a different budget (travel vs. training line items) and thus may not serve as a true savings to a department (although it is an overall company savings).
If we look at computer-based training such as attending a compliance teleconference/webinar or purchasing a recorded version, we can often get the cost down for the "registration" and eliminate the travel. As we'll see below, though, this eliminates the ability to achieve the other 3 factors, starting with timing.
To put it simply, to have someone out of the office - regardless of the technology tools you give them - costs productivity. Most of us view travel time as (some degree of) time away from the office or, at minimum, reduced work intensity level. Thus, while we check email and might work on Word or Excel or Powerpoint documents, by and large, we are not as productive traveling as are when we're plugged in at the office, available for spur of the moment questions, meetings, informal discussions, and so on.
Thus, time spent traveling to training acts as a drag on productivity.
There is also the additional challenge - and a very real one in today's fast-paced business climate - the schedule. If an external class or conference, or a webinar, is not held when we need it, then we don't go. Or the timing of the event might be incredibly inconvenient - maybe only 2 of the 10 team members can attend.
Conversely, with an onsite workshop, the timing and scheduling is up to you. You are in complete control. And this degree of control is hard to beat.
The only exception is IF - and that's a big IF - a pre-recorded FDA compliance/quality system webinar or teleconference happens to have taken place before you needed it (so it's available). At best, this is a 50-50 proposition.
Thus, we can see that in terms of timing and scheduling (and productivity), more often than not, an onsite workshop is better than waiting for the right external class at the right time and hoping it comes before it's too late. I have a friend who tells a great - albeit tragic - story about registering and waiting to attend an upcoming webinar on step-by-step FDA inspection readiness only to have the FDA show up on the morning of to begin their inspection. Needless to say, she and her team missed the webinar.
Simply put, for anything external - attendance at a class or industry conference or a generic compliance webinar - customization does not exist. Period. You get what the webinar, conference, and third-party planners involved believe will bring them the greatest amount of attendees (i.e., revenue) so it's always hit-or-miss as to how helpful any external event will be to your specific questions, concerns and needs.
On the other hand, an onsite workshop can be just as generic if you fail to work with the trainer/consultant to ensure customization that you need.
Here's the process I usually go through:
- Initial discussion - this could be through email or phone
- Draft high-level outline and agenda of the workshop - the goal here is to make sure I'm hitting all the big issues of concern and to get my host to think "Hmm...what else?"
- Second discussion - often this is a teleconference with the host and his/her colleagues to discuss very specific questions within those bigger items they need answers on
- Draft the workshop presentation - this gets sent to the host to review
- Finalize the presentation and handouts
The point is that by the time I arrive to conduct the workshop, my host and his/her colleagues knows that they will get all the answers to their questions. This is a great feeling to have heading into an FDA compliance training session.
I also like to make sure to leave time on the agenda to do more than just Q&A, I love to get hands-on walkthrough of their processes and facilities in order to really bring home the points I made. This is what I'll call the fourth consideration, "Free Consulting."
One topic I'm often asked to speak on is 21 CFR 11 or Part 11 compliance - what it looks like today, how to go about it cost-effectively, how FDA enforces Part 11 today, etc.
So, invariably, I run the workshop, and then, as part of the agenda, I spend a few hours with the team walking around to their various points of concern - in the factory, in the labs, in the offices. In essence, I'm taking them on a walkthrough of a mock FDA inspection.
And it's fascinating watching folks who, just minutes ago were nodding their heads at "don't share passwords," go to a computer system to login, announce "Oh, this is Mike's login - no problem, here's his password" (and they lift up the keyboard to reveal a sticky note of userIDs and passcodes).
Of course, I raise my eyebrows and say, "ahem." And everyone pauses, confused for a split second - and then, voila, the training sinks in. "Ohh...."
This is what I call "free consulting" - spending a few hours doing a real-world walkthrough of issues and questions in your environment when all you've paid for is an FDA compliance training workshop.
When you bring in someone to conduct an onsite workshop, make sure that individual comes with good recommendations - don't just pick someone because they spend $10,000 a month on Google advertising and their ad popped up first. Look at their previous attendee testimonials (there should be more than three or four), ask to see the trainer's resume/CV. Find out if they are willing to sign your non-disclosure agreement (it is your information, questions, etc., afterall).
Make sure that you and your team will have real-world, tangible - and accomplishable - next steps to take home as part of the training. Ensure that helpful handouts - checklists, article reprints, etc. - will be provided. And find out if the trainer is willing to be contaced over the next few weeks after the training with follow-up questions.
All of these will help customize your training experience and help you rapidly show a positive ROI.
Don't forget to join me:
April 30: Step-by-Step Guide to FDA Inspections