Conducting Effective GMP
Training
Do's and Don'ts for Success!
by David Markovitz
President and Founder - GMP Training Systems, Inc.
Conducting effective GMP training leads to improved performance.
Performance is required to maintain a profitable and competitive business.
GMP training is a means to this end - the end being people throughout the
organization contributing their talents and skills towards accomplishing
the organization’s goals and objectives.
Successful training consists of three important phases; Planning the
Training, Conducting the Training, and Effective Follow-up after the
training. This article address the second phase - Conducting the Training.
The first phase was addressed in an article in the April 1999 issue -
Practical Preparation for Effective GMP Training: 6 Steps to Success.
Once all the preparation has been completed, it’s now time for the
delivery phase which we call Conducting the Training. For many people,
delivering training can be stressful. Dealing with everything which can go
wrong due to the lack of or inadequate preparation only adds to this
stress. This stress can be prevented with careful and proper preparation.
Preparing yourself for conducting training is the best antidote to
dealing with the related stress. There’s an old joke from vaudeville that
starts with one person asking another for directions. “How do you get to
Carnegie Hall?” The answer, of course, is “Practice, practice, practice.”
This certainly applies to the training arena. First - know your stuff.
Anyone responsible for GMP training should know the regulation and keep
current. Second, develop and refine your presentation skills.
There are two organizations which provide opportunities for developing
good platform skills. The American Society for Training and Development (ASTD)
is an organization comprised of training professionals. With local
chapters throughout the United States and links to international training
organizations, ASTD provides a wealth of opportunities for developing
training skills. Toastmasters International (TI) is an organization
comprised of thousands of local clubs throughout the world. Membership is
open to anyone interested in improving their public speaking skills
through coaching, guidance and practice with other developing speakers and
trainers. Both ASTD and TI can be found on the Internet.
Following is a list of some Do’s and Don’ts when conducting GMP
training. It is not meant to be an exhaustive checklist, rather a list of
ideas for your consideration as you prepare for the task of conducting
training.
DO'S
DO prepare before the session starts. Don’t try to wing it. Know the
content and anticipate questions. Relax and calm yourself just before the
session begins. There are several techniques for this - find one that
works for you. Get enough sleep the night before the session. Be ready.
DO plan additional travel time to arrive at the training site with time to
spare. DO arrange for someone from management to “kick-off” the training
session, if possible. This helps establish the importance of the session.
Coach them on the content and timing. Beware of managers who want to teach
the class for you - before you know it, thirty precious minutes have been
consumed when you’ve planned on ten. Now you have to play catch-up. DO
have additional pens or pencils available as well as some extra paper for
note-taking. You’d be surprised at how many people show up for a training
session without a pen or pencil. A better idea is (providing the budget
allows it) to provide pens with a GMP message on them. These can then be
given to each participant. DO encourage people to interact with those
they normally don't interact with. This can be done by pre-assigning
seating. People generally have a tendency to sit next to people they
already know - usually people they work with every day. There’s much to be
gained by interacting with others - new insights and perspectives. Assign
seating by birthdays (not years, but months). Those born in January and
February, sit at this table. March and April, sit here, and so forth.
There are many techniques that can be used. Be creative. DO explain the
objectives of the training session to the participants. DO allow people
to ask questions and ask for clarification as you go along. Don't start
the training by saying, “Hold your questions until the end.” Rather,
encourage people to interact with you along the way. If someone asks a
question that you know will be answered in a subsequent section, it’s OK
to say, “We’ll cover that later in the session”, and ask if they’re
willing to wait. Most people will be happy to wait and be flattered that
they thought of a question that’s relevant. DO ask for help with
unforeseen logistical details. Surely, one of the participants will be
glad to assist in resolving any difficulties.
DO conduct some sort of icebreaker activity. It can be as simple as asking
everyone to introduce themselves. Introduce yourself and make sure your
include background information indicating your qualifications. DO have
name tents available. These can be prepared ahead of time if possible, or
filled in by the participants. (Supply broad tipped markers for this.)
Create a name tent for yourself to serve as a model. Be aware of your
audience and the culture of their organization. Some cultures are more
formal than others. DO use people’s names as much as possible. People
like to hear their name. Start with the more outgoing, extroverted people.
You’ll know who they are, they let you know. However, don't let them
dominate the discussions.
DO talk with people, not at people. Think of yourself as sharing
information you have. Be careful about preaching - it makes some people
uncomfortable. DO move around during the training session. This enables
all participants to see and hear you adequately.
DO speak loudly enough for everyone to hear you. DO use vocal variety
to make the subject sound interesting. DO use gestures to help people
“see” the points you’re making. Be aware of cultural taboos when working
with multi-ethnic groups.
DO ask participants to speak loudly enough to be heard by all when asking
questions or making comments. It may sometimes be necessary to repeat
questions and comments in order for all participants to hear. DO have a
plan for using videotapes. Ask participants to take notes during the tape,
or to look for certain things. Have them actively watch the video, not
passively view the tape. Stop the video at strategic times for discussion.
DO design interactive activities for participants. Get them actively
thinking and participating with others in the session. DO use props and
graphics to emphasize points and add clarity. Remember, a picture is worth
a thousand words. If using graphics produced on software, such as
Microsoft PowerPoint, be sure to design the slides so they are readable
from the back of the room. If using a computer projection device, test the
colors with the exact computer and exact device ahead of time. Avoid too
many colors or the elaborate backgrounds available on many software
packages. Avoid using too many glitzy transitions and animation devices
that are becoming more readily available and easy to use. Don’t try to
dazzle your audience with your brilliant use of software - remember that
the aim is learning. Be sure that text is simple and big enough to be read
from the back of the room. A good guideline is no more than five lines of
text per slide. If using overhead transparencies, print them on a color
printer. Using black and white transparencies today is like watching your
favorite movie on a black and white television.
DO stay out the way of your visuals. If you have an image projected on a
screen behind you, make sure that you are not standing in the way so that
some participants cannot see the screen. DO pay attention to that
international radio station WII-FM (What’s In It For Me?). Be sure to
address what the participants stand to gain by attending the training
session. You can demonstrate how GMP compliance leads to lower levels of
rework, fewer schedule changes, or reducing other sources of stress in the
workplace. DO inject humor. GMP is a serious topic, but humor has been
proven to enhance learning. Look at the daily comics in the newspaper.
Read them with an eye towards reinforcing points in the training. Make
transparencies of appropriate comics. Don't reproduce them in your
handouts (be aware of copyright law). DO tell stories to emphasize
points. People remember the stories. They become the hook upon which they
remember the points. Use these stories to create pictures in the minds of
the participants. DO obtain local examples of stories that the
participants can recognize. Recent occurrences that might have been
prevented by applying the principles of GMP are always helpful in helping
the participants understand the power of GMP compliance. These can often
be provided by people in the Quality Assurance or Regulatory Affairs
departments. Additionally, the FDA journal, FDA Consumer , contains
information on recent incidents in industry. DO summarize the training
session at the conclusion and relate it to their job responsibilities.
Remind people of what we have just learned and how it can help them in
their jobs every day. DO prepare and issue a training record or a
certificate to the participants. There are commercial software programs
available that prepare very nice certificates and certificate paper is
available from several sources.. DO make sure you document the training.
The FDA reminds us continually that “If it isn’t written down, it didn’t
happen.” A good training documentation record contains the name and date
of the class, the name and signature of the instructor, an outline of the
class contents, typed or printed names of the participants, and the
signature of each participant.
DON’TS DO NOT use videos right after lunch. Blood rushes to the belly to
aid in digestion after eating, dimming the lights will only enhance people
to become sleepy. Instead, plan an activity for right after lunch. DO
NOT call on people to answer questions or to participate. Avoid saying
things like, “John, we haven’t heard from you in a while. What do you have
to say about this issue?” These types of statements make everyone
uncomfortable. Rather, design activities where they interact with others.
DO NOT ask questions of the participants that they will not have the
answers to. You do not want the participants to feel ignorant. You want to
build their confidence in the subject matter. DO NOT say, “Do you have
any questions?” Rather, use “What questions do you have?” This
acknowledges that some of them may indeed have questions and that you’re
open to addressing those. DO NOT purport to be the only expert in the
room. Usually, knowledge regarding cGMP exists within the group. Your role
in addition to instructor is that of facilitator. Tap into the knowledge
and experience of some of the more senior and experienced participants to
make certain points. DO NOT run overtime. The group will usually let you
know when the ending time is approaching. You’ll see people closing books,
putting pens and pencils away, packing briefcases and bags, ... The group
will stop learning when the appointed hour arrives, whether you’re
finished or not. You run the risk of undoing any favorable results by
running over into the participants’ personal time.
DO NOT let breaks get out of control. In many organizations, ten minute
breaks are really fifteen minutes, and fifteen minute breaks are really
twenty minutes. We recommend a ten minute break (really ten minutes) after
each 60-75 minutes of training. Starting on-time after breaks sends a
strong message that breaks are meant to be only ten minutes, and not
longer. Make sure you look at the clock and record the time when the break
starts, so you can be sure to start up again on time. DO NOT make up
answers to questions when you don’t know the answers. Instead, acknowledge
the question as an excellent question, and commit to researching the
answer and corresponding with the person who asked the question. DO NOT
get engaged in a debate or extended discussion with any individual
participant. The remaining participants may not have an interest in that
specific point and may begin to get bored. Instead, offer to further
discuss this point with that individual at a break or at the conclusion of
the session. DO NOT take it personally if one or two participants seem
disinterested. It may be for several reasons, many of which are not
related to the class. An individual may have been awake all night with a
sick child, and is nodding off from lack of sleep, not boredom. Now, if
everyone’s nodding off, that’s a different story. DO NOT panic when
something goes wrong. Usually, things will work out. As the instructor,
you have authority in the room and people will look to you to take the
lead. Learn to adapt to circumstances by being prepared. That means having
a back-up set of overhead transparencies to use if the computer projection
system crashes. That means having an extra chair or two and training
materials for someone who unexpectedly arrives for the training session.
That means taking charge during a fire drill in the middle of the training
session (Yes, that does occur). DO NOT lecture more than about fifteen
minutes at a time. People’s attention spans are growing shorter and
shorter with all the recent advances in multi-media. Variety makes an
effective training session. Lecture, discussion, small group exercises,
simulations, video clips are all training methods which can be used
effectively. DO NOT show more than fifteen minutes of video at a time.
Preview the videos in advance to determine where the tape can be stopped
for discussion or an activity. Many videos are thirty minutes or longer.
Show these as clips - it’s not always necessary to show the entire video.
DO NOT tell jokes unless you’re good at it. And even then, be careful not
to offend anyone. Telling funny stories (usually about yourself or your
experiences) works better. DO NOT be boring. Sure, GMP is a serious
topic, but it doesn’t have to be dull. Make the training session lively.
DO NOT leave immediately at the conclusion of the training session. Be
available to talk to individuals from the session who may want to talk
with you one on one.
DO NOT forget to document the training. One very important thing to
keep in mind is to develop your own presentation style. Find what’s
comfortable for you, and work to enhance your delivery skills over time.
Pay attention to the speaker’s style and technique as you attend seminars
and conferences yourself. Don’t be afraid to try to incorporate some new
techniques into your presentation style. Avoid trying to copy someone
else’s style because you like how they do it. Analyze what they do and
choose those elements that will fit in with what you’re already doing.
The more training you conduct, the more confident you will become.
Confidence is that crucial element that often separates good trainers from
the others. Above all, relax, have fun, and show your passion for making
GMP compliance a means for improving overall performance throughout your
organization.
These Do’s and Don’ts are meant to be a series of tips for your
consideration when conducting your training sessions. Remember that the
aim of training is learning. In our next and final article in this series,
we will explore tips on effective follow-up after the training has
occurred.
David Markovitz is the Founder and President of
GMP Training Systems, Inc. and the Institute for
Effective Innovation, a company created to help people in organizations
become self sufficient with innovation by equipping them with time tested
tools, the best resources, and expert coaching. Learn more at
www.TheInnovatorsWay.com.
David can be reached at 714-289-1233 or
David@GMPTrainingSystems.com
1Markovitz, David C., "Practical Preparation for
Effective GMP Training: 6 Steps to Success," Journal of cGMP Compliance,
Vol. 3, No. 2, January 1999, pp 68-72. 2American
Society for Training and Development can be found at
http://www.astd.org. Their mailing
address is: 1640 King Street, P.O. Box 1443, Alexandria, VA 22313-2043
USA. Phone: 800 628-2783. Toastmasters International can be found at
http://www.toastmasters.org.
Their mailing address is P.O. Box 9052, Mission Viejo, CA 92690 USA.
Phone: 949 858-8255. 3FDA Consumer is
available on the Internet at
http://www.fda.gov.

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