Auditing The
Training Function
T
raining is a Current Good
Periodic audits are Manufacturing Practice
(cGMP) requirement.
used to verify the Like other cGMP requirements,
this function should be periodi-
existence of, and cally audited to verify that it is
the effectiveness working as intended. A summary
of key points to be evaluated in
of systems, an audit is provided in this arti-
cle. These points may be used
procedures, and to construct a customized check-
other controls list for training audits.
The regulatory requirement to
to ensure that have adequately trained person-
nel to perform the various tasks
manufacturing associated with the manufacture
and testing are of drug or medical device prod-
ucts is as much a part of the reg-
consistently ulation as manufacturing and lab-
oratory controls. Periodic audits
accomplished are used to verify the existence
of, and the effectiveness of sys-
within specified tems, procedures, and other con-
parameters. trols to ensure that manufacturing
and testing are consistently ac-
complished within specified para-
meters. The audit of the training
function has the same objective.
Since training is the method that
most personnel learn how to per-
form their tasks, adding the train-
ing function to audits will provide
additional and useful insight into
the capability of personnel who
are assigned the various cGMP-
regulated tasks. While this article
by is primarily written for internal au-
David E. Jones, M.S., R.Ph. dits, many of the points men-
President tioned may be equally useful in
Biz-Tech Associates conducting vendor or contract
130 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
service provider audits. Although
the tasks of manufacturing med-
ical device products may differ
considerably from those employ-
ed to make pharmaceutical pro-
ducts, the overall approach to
auditing the training process ap-
plies to either.
If the reader desires more
background on Food and Drug
Administration (FDA) concerns
about training, examples are
provided in Figure 1.
The Regulatory Require-
ment
Just like other requirements,
the need for training is detailed
in both the cGMP regulations for
drug and medical devices. They
are provided here for the reader’s
convenience.
§ 211.25 Personnel qualifications
(a) Each person engaged in
the manufacture, process-
ing, packing, or holding of
a drug product shall have
education, training, and
experience, or any combi-
nation thereof, to enable
that person to perform the
assigned functions. Train-
ing shall be in the particu-
lar operations that the em-
ployee performs and in
current good manufactur-
ing practice (including the
current good manufactur-

ing practice regulations in this chapter and
written procedures required by these regula-
tions) as they relate to the employee’s func-
tions. Training in current good manufacturing
practice shall be conducted by qualified indi-
viduals on a continuing basis and with suffi-
cient frequency to assure that employees re-
main familiar with cGMP requirements ap-
plicable to them.
(b) Each person responsible for supervising the
manufacture, processing, packing, or holding
of a drug product shall have the education,
training, and experience, or any combination
thereof, to perform assigned functions in
such a manner as to provide assurance that
the drug product has the safety, identity,
strength, quality, and purity that it purports
or is represented to possess.
(c) There shall be an adequate number of quali-
fied personnel to perform and supervise the
manufacture, processing, packing, or holding
of each drug product.1
§ 820.25 Personnel
(a) General. Each manufacturer shall have suffi-
cient personnel with the necessary educa-
tion, background, training, and experience to
assure that all activities required by this part
are correctly performed.
(b) Training. Each manufacturer shall establish
procedures for identifying training needs and
ensure that all personnel are trained to ade-
quately perform their assigned responsibili-
ties. Training shall be documented.
(1) As part of their training, personnel shall
be made aware of device defects which
may occur from the improper perfor-
mance of their specific jobs.
(2) Personnel who perform verification and
validation activities shall be made aware
of defects and errors that may be encoun-
tered as part of their job functions.2
Notice that the regulation alludes to the compe-
tence of personnel, which implies that the training
has been effective. The regulation doesn’t merely
say, “provide training sessions.” If the training is in-
effective or inadequate, personnel competence to
perform a specified task is not a certainty. The
writer feels that the intent of the regulatory require-
ments are to enable personnel to perform tasks
correctly. If the training provided falls short of that,
C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s
David E. Jones, M.S., R.Ph.
the training has not met the intent of the regulation.
This is one of the key questions to be answered in
the audit.
One is typically obliged to ask a variety of ques-
tions in determining the effectiveness of the train-
ing function. Those questions may center on many
or all of the following training issues:
• Is the training function clearly assigned?
• Is the assignment of responsibility in writing?
• Is there an overall training program with dis-
creet modules for orientation, SOP training,
periodic retraining?
• Does training include the “why” or the “ratio-
nale” for specified steps?
• Are the trainer or trainers qualified?
• How are they qualified?
• Is training conducted with sufficient frequency?
• How is this frequency established? What
about the need to retrain?
• Is training or learning evaluated to ensure
competency?
This is accomplished through tests, observation,
and other methods including:
• Is evaluation against written standardized cri-
teria?
• Is on-the-job training evaluated. How is it ac-
complished?
• Are written training records kept in a central
location (often part of human resources)?
• Are written training records kept on a depart-
mental basis?
• Are training records complete, accurate, and
current?
• Can you verify that training records match job
training requirements for at least three employ-
ees in each department?
• Do training records indicate gaps in training
(whether through a manual comparison of
paper records or through a query to an elec-
tronic database), i.e., who hasn’t been trained?
• Are employee errors recorded, and used to
determine if retraining may be required?
• Are training gaps addressed promptly through
make-up training sessions?
• Is the training function audited with sufficient
frequency?
• How is the frequency determined?
• Have previously identified deficiencies been
corrected in a timely fashion?
131
David E. Jones, M.S., R.Ph.
In addition to the issues listed, other sources
may also be useful. Reviewing the Annual Product
Reviews (APRs) prepared by the company for two
or three consecutive years will provide useful in-
sight into the volume and diversity of the operation
and, importantly, clues into a company’s state of
control if failed or reworked batches of product are
more than a few. Bear in mind that failures may be
higher if a new product has been added to a par-
ticular site, although, realistically, one would hope
that appropriate technology transfer would prevent
a high failure rate. What about complaints and the
trending of complaints? Any clues on training
here?
Does the organization have a stated training
policy or a training Standard Operating Procedure
(SOP)? If either of these exist, they will provide a
starting point to compare what the audit finds
against what the procedure or policy expects.
Neither the cGMP regulation for medical device
or drug product manufacture requires a firm to
have a training department, therefore the audit
should determine that the function is assigned,
performed, and documented. Regardless of how
the training function is organized or to whom as-
signed, is the person(s) who provide the training
qualified? The regulation does not offer the spec-
ifics of what constitutes qualification, so the writer
offers a practical approach to qualification through
several questions:
• Does the trainer have the technical expertise
required to train on the assigned subject?
• Does the trainer have knowledge of company
specific SOPs to train on the assigned subject?
• Does the trainer have training expertise?
These are not absolute requirements, but they
broadly represent the ideal. If any of these are ab-
sent, the effectiveness of the training may be less
than optimal.
Frequency of training and retraining is determin-
ed by subject companies. Retraining may not be
routinely required for a process or operation that is
repeated with high frequency, such as once or
twice a week for much of a year. But the converse
creates a true training challenge. What if a particu-
lar product is manufactured only once per year, or
less, and further, there are difficult and unusual
steps involved? Although a person may have been
trained on the procedures 18 months ago, is that
person ready to make a batch today if that knowl-
132 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y
edge has never been used before? Again, the key
question is: “Is the person competent to manufac-
ture the subject product today?”
What about changes in SOPs? When are em-
ployees retrained and by whom and how? What
records are available to support the training?
There’s a significant difference between training
and understanding, versus a sheet of paper that
merely suggests that training occurred.
If you may, chat with several employees about
critical SOPs on which they have been trained ac-
cording to records. Can you verify through a series
of questions that these employees understand the
SOPs well enough to perform the tasks? It’s best
to assure these employees that you’re merely veri-
fying their understanding of operating procedures
and you’re not there on a ‘witch hunt.’
A sign-in sheet for a particular training session
is a typical and useful start for documentation. Ver-
ify that such records are available, including: title of
the training session, number or abbreviation for the
session if one is assigned, date of the training ses-
sion, length of the training session in hours, and in-
structor or instructors name(s).
If individual entries are then transcribed from
these sign-in sheets into an employee’s personal
training record, how is the accuracy of the tran-
scription verified? Regardless of how training re-
cords are maintained – paper system or electronic
database – can one verify who has been trained
and who has not been trained on specific modules?
Review a sufficient number of training records to
ensure that records are consistent, current, and ac-
curate. Looking at the records for at least three em-
ployees in at least three different departments
would be a reasonable start.
If an electronic database is used, then confor-
mance with the applicable sections of 21 CFR11,
the regulation for Electronic Records and Electronic
Signatures, will apply. Such a review and determi-
nation are beyond the scope of this article.
Regardless of the method used to store training
records, review enough of them to ensure that re-
cords are consistent, current, and accurate.
Once you have verified that training occurred,
take a look at the materials used for the training.
What did the learner see, listen to, or work with? Is
a handout available for your inspection? What
about videos, audio tapes, PowerPoint® presenta-
tions? Was a confirmation quiz used? Did all em-
ployees pass the quiz? All of these elements relate
to the consistency of the training provided.
 David E. Jones, M.S., R.Ph.

Figure 1
Examples of Training Deficiencies From FDA Warning Letters
While the writer cannot speak for the FDA, the writer has heard a consistent and recur- SERVICES
ring message at various FDA industry training workshops and seminars in recent years. AN •U
UM

SA
Simply stated, FDA’s firm inspection programs identify deficient or inadequate training in a

H
F HEALTH &
variety firms on an on-going basis. A review of Warning Letters posted on the FDA web site
at http://www.fda.gov/foi/warning.htm offers examples to support the statement just made.
Training is not mentioned in every Warning Letter because sometimes FDA field personnel

TO
merely identify the impact of the inadequate training, such as “failure to follow procedures,”

EN
“failure to keep adequate records,” or “failure to record and justify deviations,” rather than TM
DEPAR
speculate on why deficiencies have been observed. If a pattern of mistakes are observed,
it is then not uncommon to review the training program and training records.

“4. Failure to establish written procedures for the training of individuals involved in the gaseous and liquid
medical oxygen operations [21 CFR 211.25(a)] . Investigator observed that your firm has no written proce-
dure for training. Your firm is expected to establish detailed written procedures (training program) outlining the
specific areas of the firm’s operation to be covered. On-the-job training is acceptable, as long as the training is
conducted by a qualified individual.” [d1466b]3

“Failure to have in place an adequate organizational structure and sufficient personnel to assure devices are
manufactured in accordance with the QS regulation and to establish a formal Quality Assurance program includ-
ing the establishment of written procedures that address management responsibility, quality audits, personnel,
training, design controls, corrective and preventive action, and nonconforming product review.” [d1452b]

“Following recognition of the initializing variables problem trend, no formal documented training was provided
to key personnel to prevent its recurrence, e.g. training of programmers, software engineers, and quality assur-
ance personnel.” [d1718b]3

“Failure to establish procedures for identifying training needs and ensure that all personnel are trained to ade-
quately perform their assigned functions. [21 CFR 820.25(b)l For example, there are no written procedures or
documentation describing any training activities provided to your employees regarding their assigned functions or
the requirements of your quality system procedures.” [m598n]3

“Failure to establish and maintain procedures for identifying training needs to ensure that all personnel are ad-
equately trained to perform their assigned responsibilities and for maintaining required training records.” [d1360b]3

“211.25 Personnel qualifications. The training program fails to assure your employees and supervisory employ-
ees are trained in the specific tasks and in their assigned responsible functions. Examples from FDA-483 Item
number 5 are:
a. There are no written procedures for conducting training for specific tasks or for good laboratory practice
training. 211.25(a)
b. The training records do not sufficiently document that analysts have been trained for the specific tasks
that they perform. 211.25(a)
c. There is no documentation that management reviewed the adequacy of the training.
211.25(b).” [m5089n]3

“You failed to specify how initial training of new employees would be conducted, as required by 21 CFR
820.25, in your procedure QO03, “Personnel.” [g1728d]3

“Failure to document training to ensure that all personnel are trained to adequately perform their assigned re-
sponsibilities [21 CFR 820.25(b)]. For example:
a. Training files for laboratory technicians contain no documentation that they were trained in
.
b. There is no documentation to show that technician ‘was retrained after making multiple errors in QC
testing.
c. Required supervisor signatures were missing in the training records of the current, recently promoted,
QC supervisor.” [m3150n]3

“Failure to provide training that is adequate to enable employees to perform their assigned duties and func-

C o n d u c t i n g Au d i t s, G A P A s s e s s m e n t s, & C o r r e c t i ve A c t i o n s 133
David E. Jones, M.S., R.Ph.

Figure 1
Examples of Training Deficiencies From FDA Warning Letters (Continued)
tions as required by 21 CFR211 .25 (a). For example, there is no written evidence that employees have received
proper training in the and current Good Manufacturing Practice. [m3681n]3

“Failure to have personnel responsible for supervising the manufacture, processing, packing or holding of drug
products with sufficient education, training, and experience to perform their assigned functions so as to assure
that drug products have the safety, identity, strength, quality, and purity they purport [21 CFR 21 1.25(b)]. Specifi-
cally, the Operations Manager, who has been in this position at the facility on for seven months, has
not received cGMP training for drug products. This manager also has distribution authority over drug products at
your facilities in [four sites named]. [g1150d]3

The reader may download the complete Warning Letters by entering the following complete address:
www.fda.gov/foi/warning.htm

These letters are stored in Portable Document Format (*.pdf) and must be read by the Adobe Reader pro-
gram, which is available for free download from the FDA web site as well as IVT’s web site and others.

For on-the-job training, is a standard checklist References

used to verify the employee can demonstrate the 1. The Current Good Manufacturing Practice Regulation
required knowledge and skill? Who administers the for Finished Pharmaceuticals, 21 CFR 211, 43 FR
review? Are these reviews available for review? 45076, September 29, 1978 as amended through Oc-
tober 2001 when downloaded.
2. The Current Good Manufacturing Practice Regulation
Conclusion for Medical Devices, 21 CFR 820, 1996.
3. FDA. FOI Reading Room. www.fda.gov/foi/waring.htm.
Training is a regulatory requirement. Because it’s Figure 1.
a part of the regulation, and has direct bearing on
the knowledge and skills of operating and testing Suggested Reading
• Jones, D. “The Training Side of Change Control.” Jour-
personnel, the function should be periodically au-
nal of cGMP Compliance. Vol. 2, No. 4. (July). 1998.
dited. Auditing the training function of a firm need • Jones, D. “Conducting Effective cGMP Training Ses-
not be an overly complicated task. By knowing what sions for Operators or Technicians.” Journal of cGMP
to look for – based on preparation and augmented Compliance. Vol. 2, No. 2. (January). 1998.
by clues from other aspects of operations – an ef- • Jones, D. “Enabling Employees to Follow GMPs Step-
by-Step Everyday: A Basic Approach to Achieve Com-
fective approach to conducting such an audit will be
pliance and Performance” Journal of cGMP Compli-
made easier. ❏ ance. Vol. 5, No. 3. (April) 2001.
• Jones, D., Markovitz, D. “Developing a Bulletproof
GMP Training Program from the Ground Up: A Nar-
About the Author rative.” Journal of cGMP Compliance. Vol. 3, No. 2.
(January). 1999.
David E. Jones, M.S., R.Ph., is the founder of Biz- • Lincoln, J.E. “Effective Training Program Considera-
Tech Associates, a training and consulting service, tions for Medical Device Manufacturers.” Journal of
which trains and audits client companies on drug GXP Compliance. Vol. 6, No. 2. (January) 2002.
and medical device cGMPs. He was formerly a
Vice President of A. H. Robins Company where he Article Acronym Listing
was responsible for four business units that manu- API: Active Pharmaceutical Ingredient
factured Active Pharmaceutical Ingredients (APIs) APR: Annual Product Review
and pharmaceutical products. Previously, he pro- cGMP: Current Good Manufacturing Prac-
vided training and consulting on a contract basis to tice
clients of GMP Institute and ISPE, and has worked FDA: Food and Drug Administration
with the FDA on several training-related projects. PDF: Portable Document Format
He can be reached by phone at 804-639-6655, or SOP: Standard Operating Procedure
by e-mail at cGMPman@aol.com.
Originally published in the April 2002 issue of the Journal of GXP Compliance

134 I n s t i t u t e o f Va l i d a t i o n Te c h n o l o g y