41
• Win respect by being respectable and respectful. To retain this self-respect, it is
better to displease people by doing what you know is right than to appease them
by doing what is wrong.
• When looking for a job, find a company that listens to its people and offers train-
ing programs and education benefits.
The last, of course, is a segue to the important topic of training. Some companies are
prescient enough to offer intensive, not perfunctory, training programs to foster promo-
tion and career growth, and make these courses mandatory for employees. In fact, such
training should be understood and agreed to as a condition of employment, and discussed
at quarterly reviews and annual performance appraisals. I believe that more intelligent
employees make a more successful company. If you were company president, would you
not want your regulatory department staffed by the very best people you could find?
Peter Drucker, a world-renowned management consultant, says, “The world is not
becoming labor-intensive, nor material- or energy-intensive, but knowledge intensive.”
If a company does not offer training or educational opportunities, it behooves each
employee to assume that responsibility on his or her own. There is no lifetime security
guarantee, no matter who the employer may be.
In Good to Great, an excellent and highly regarded book published in 2001, author Jim
Collins describes companies that excel as those that hire the right people.1 These individu-
als do not need to be tightly managed or inspired they are self-motivated by the drive
to produce the best results and be part of creating something great. Collins further adds
that great vision without great people is irrelevant. My teaching philosophy is to help
identify those characteristics. After 40 years in the business, including innumerable per-
formance appraisals, I have some insight into the difference between right (valuable) and
wrong (mediocre) employees. If there is no inclination to improve or lack of motivation,
there is no reason to retain these employees. Collins noted that having the wrong people
hang around is unfair to all the right ones. The right ones inevitably find themselves
compensating for the inadequacies of others and can become frustrated, look for other
opportunities and, regrettably, resign.
Training and education are best done in small doses, perhaps most elegantly
described in an article in the Harvard Business Review.2 Trying to improve one step at a
time is far better than constantly “shooting for the moon.” Employees should be encour-
aged to aim for reasonable progress and employers should recognize employees that do
well. Educational programs should be divided into company-required and job-essential
training. The company-required portion could include new employee orientation, records
management, healthcare compliance, diversity awareness, and ISO and QSR compliance.
Job-essential sections could include an introduction to appropriate literature complaint
reporting data entry computer, library and Internet use filing requirements legal respon-
sibilities and personnel practices. Employees should be responsible for meeting assigned
study completion dates. Progress should be discussed during quarterly reviews and docu-
mented in annual performance appraisals.
Required reading is another training category. It includes all the relevant procedures
and work instructions, the Food and Drug Act, federal and international regulations and
guidance documents, and a selected reading list featuring such books as The Jungle,3 Pure
Food,4 Protecting America’s Health,5 Clinical Trials,6 On Writing Well,7 The Elements of Style,8
Getting to Yes9 and Medical Uses of Statistics.10
Competency measures should be developed and documented. Professional training
could include outside team building, leadership development, financial planning, basic
auditing, conflict management, negotiation techniques, sterilization methods, standards
development, clinical trial management, design of experiments courses, as well as other pro-
grams offered by the Regulatory Affairs Professionals Society (RAPS) or The Food and Drug
Law Institute. Course attendance should be recorded and maintained in employee personnel
A Regulatory Affairs Lifetime Philosophy of Learning
• Win respect by being respectable and respectful. To retain this self-respect, it is
better to displease people by doing what you know is right than to appease them
by doing what is wrong.
• When looking for a job, find a company that listens to its people and offers train-
ing programs and education benefits.
The last, of course, is a segue to the important topic of training. Some companies are
prescient enough to offer intensive, not perfunctory, training programs to foster promo-
tion and career growth, and make these courses mandatory for employees. In fact, such
training should be understood and agreed to as a condition of employment, and discussed
at quarterly reviews and annual performance appraisals. I believe that more intelligent
employees make a more successful company. If you were company president, would you
not want your regulatory department staffed by the very best people you could find?
Peter Drucker, a world-renowned management consultant, says, “The world is not
becoming labor-intensive, nor material- or energy-intensive, but knowledge intensive.”
If a company does not offer training or educational opportunities, it behooves each
employee to assume that responsibility on his or her own. There is no lifetime security
guarantee, no matter who the employer may be.
In Good to Great, an excellent and highly regarded book published in 2001, author Jim
Collins describes companies that excel as those that hire the right people.1 These individu-
als do not need to be tightly managed or inspired they are self-motivated by the drive
to produce the best results and be part of creating something great. Collins further adds
that great vision without great people is irrelevant. My teaching philosophy is to help
identify those characteristics. After 40 years in the business, including innumerable per-
formance appraisals, I have some insight into the difference between right (valuable) and
wrong (mediocre) employees. If there is no inclination to improve or lack of motivation,
there is no reason to retain these employees. Collins noted that having the wrong people
hang around is unfair to all the right ones. The right ones inevitably find themselves
compensating for the inadequacies of others and can become frustrated, look for other
opportunities and, regrettably, resign.
Training and education are best done in small doses, perhaps most elegantly
described in an article in the Harvard Business Review.2 Trying to improve one step at a
time is far better than constantly “shooting for the moon.” Employees should be encour-
aged to aim for reasonable progress and employers should recognize employees that do
well. Educational programs should be divided into company-required and job-essential
training. The company-required portion could include new employee orientation, records
management, healthcare compliance, diversity awareness, and ISO and QSR compliance.
Job-essential sections could include an introduction to appropriate literature complaint
reporting data entry computer, library and Internet use filing requirements legal respon-
sibilities and personnel practices. Employees should be responsible for meeting assigned
study completion dates. Progress should be discussed during quarterly reviews and docu-
mented in annual performance appraisals.
Required reading is another training category. It includes all the relevant procedures
and work instructions, the Food and Drug Act, federal and international regulations and
guidance documents, and a selected reading list featuring such books as The Jungle,3 Pure
Food,4 Protecting America’s Health,5 Clinical Trials,6 On Writing Well,7 The Elements of Style,8
Getting to Yes9 and Medical Uses of Statistics.10
Competency measures should be developed and documented. Professional training
could include outside team building, leadership development, financial planning, basic
auditing, conflict management, negotiation techniques, sterilization methods, standards
development, clinical trial management, design of experiments courses, as well as other pro-
grams offered by the Regulatory Affairs Professionals Society (RAPS) or The Food and Drug
Law Institute. Course attendance should be recorded and maintained in employee personnel
A Regulatory Affairs Lifetime Philosophy of Learning