Auditing The

Training Function
service provider audits. Although

T
raining is a Current Good
Periodic audits are Manufacturing Practice the tasks of manufacturing med-
(cGMP) requirement. ical device products may differ
used to verify the Like other cGMP requirements, considerably from those employ-
this function should be periodi- ed to make pharmaceutical pro-
existence of, and cally audited to verify that it is ducts, the overall approach to
the effectiveness working as intended. A summary auditing the training process ap-
of key points to be evaluated in plies to either.
of systems, an audit is provided in this arti- If the reader desires more
cle. These points may be used background on Food and Drug
procedures, and to construct a customized check- Administration (FDA) concerns
other controls list for training audits.
The regulatory requirement to
about training, examples are
provided in Figure 1.
to ensure that have adequately trained person-
nel to perform the various tasks The Regulatory Require-
manufacturing associated with the manufacture ment
and testing are of drug or medical device prod-
ucts is as much a part of the reg- Just like other requirements,
consistently ulation as manufacturing and lab- the need for training is detailed
oratory controls. Periodic audits in both the cGMP regulations for
accomplished are used to verify the existence drug and medical devices. They
of, and the effectiveness of sys-
within specified tems, procedures, and other con-
are provided here for the reader’s
convenience.
parameters. trols to ensure that manufacturing
and testing are consistently ac- § 211.25 Personnel qualifications
complished within specified para- (a) Each person engaged in
meters. The audit of the training the manufacture, process-
function has the same objective. ing, packing, or holding of
Since training is the method that a drug product shall have
most personnel learn how to per- education, training, and
form their tasks, adding the train- experience, or any combi-
ing function to audits will provide nation thereof, to enable
additional and useful insight into that person to perform the
the capability of personnel who assigned functions. Train-
are assigned the various cGMP- ing shall be in the particu-
regulated tasks. While this article lar operations that the em-
by is primarily written for internal au- ployee performs and in
David E. Jones, M.S., R.Ph. dits, many of the points men- current good manufactur-
President tioned may be equally useful in ing practice (including the
Biz-Tech Associates conducting vendor or contract current good manufactur-

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
 David E. Jones, M.S., R.Ph.

ing practice regulations in this chapter and the training has not met the intent of the regulation.
written procedures required by these regula- This is one of the key questions to be answered in
tions) as they relate to the employee’s func- the audit.
tions. Training in current good manufacturing One is typically obliged to ask a variety of ques-
practice shall be conducted by qualified indi- tions in determining the effectiveness of the train-
viduals on a continuing basis and with suffi- ing function. Those questions may center on many
cient frequency to assure that employees re- or all of the following training issues:
main familiar with cGMP requirements ap-
plicable to them. • Is the training function clearly assigned?
(b) Each person responsible for supervising the • Is the assignment of responsibility in writing?
manufacture, processing, packing, or holding • Is there an overall training program with dis-
of a drug product shall have the education, creet modules for orientation, SOP training,
training, and experience, or any combination periodic retraining?
thereof, to perform assigned functions in • Does training include the “why” or the “ratio-
such a manner as to provide assurance that nale” for specified steps?
the drug product has the safety, identity, • Are the trainer or trainers qualified?
strength, quality, and purity that it purports • How are they qualified?
or is represented to possess. • Is training conducted with sufficient frequency?
(c) There shall be an adequate number of quali- • How is this frequency established? What
fied personnel to perform and supervise the about the need to retrain?
manufacture, processing, packing, or holding • Is training or learning evaluated to ensure
of each drug product.1 competency?

§ 820.25 Personnel This is accomplished through tests, observation,

(a) General. Each manufacturer shall have suffi- and other methods including:
cient personnel with the necessary educa-
tion, background, training, and experience to • Is evaluation against written standardized cri-
assure that all activities required by this part teria?
are correctly performed. • Is on-the-job training evaluated. How is it ac-
(b) Training. Each manufacturer shall establish complished?
procedures for identifying training needs and • Are written training records kept in a central
ensure that all personnel are trained to ade- location (often part of human resources)?
quately perform their assigned responsibili- • Are written training records kept on a depart-
ties. Training shall be documented. mental basis?
(1) As part of their training, personnel shall • Are training records complete, accurate, and
be made aware of device defects which current?
may occur from the improper perfor- • Can you verify that training records match job
mance of their specific jobs. training requirements for at least three employ-
(2) Personnel who perform verification and ees in each department?
validation activities shall be made aware • Do training records indicate gaps in training
of defects and errors that may be encoun- (whether through a manual comparison of
tered as part of their job functions.2 paper records or through a query to an elec-
tronic database), i.e., who hasn’t been trained?
Notice that the regulation alludes to the compe- • Are employee errors recorded, and used to
tence of personnel, which implies that the training determine if retraining may be required?
has been effective. The regulation doesn’t merely • Are training gaps addressed promptly through
say, “provide training sessions.” If the training is in- make-up training sessions?
effective or inadequate, personnel competence to • Is the training function audited with sufficient
perform a specified task is not a certainty. The frequency?
writer feels that the intent of the regulatory require- • How is the frequency determined?
ments are to enable personnel to perform tasks • Have previously identified deficiencies been
correctly. If the training provided falls short of that, corrected in a timely fashion?

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 131
David E. Jones, M.S., R.Ph.

In addition to the issues listed, other sources edge has never been used before? Again, the key
may also be useful. Reviewing the Annual Product question is: “Is the person competent to manufac-
Reviews (APRs) prepared by the company for two ture the subject product today?”
or three consecutive years will provide useful in- What about changes in SOPs? When are em-
sight into the volume and diversity of the operation ployees retrained and by whom and how? What
and, importantly, clues into a company’s state of records are available to support the training?
control if failed or reworked batches of product are There’s a significant difference between training
more than a few. Bear in mind that failures may be and understanding, versus a sheet of paper that
higher if a new product has been added to a par- merely suggests that training occurred.
ticular site, although, realistically, one would hope If you may, chat with several employees about
that appropriate technology transfer would prevent critical SOPs on which they have been trained ac-
a high failure rate. What about complaints and the cording to records. Can you verify through a series
trending of complaints? Any clues on training of questions that these employees understand the
here? SOPs well enough to perform the tasks? It’s best
Does the organization have a stated training to assure these employees that you’re merely veri-
policy or a training Standard Operating Procedure fying their understanding of operating procedures
(SOP)? If either of these exist, they will provide a and you’re not there on a ‘witch hunt.’
starting point to compare what the audit finds A sign-in sheet for a particular training session
against what the procedure or policy expects. is a typical and useful start for documentation. Ver-
Neither the cGMP regulation for medical device ify that such records are available, including: title of
or drug product manufacture requires a firm to the training session, number or abbreviation for the
have a training department, therefore the audit session if one is assigned, date of the training ses-
should determine that the function is assigned, sion, length of the training session in hours, and in-
performed, and documented. Regardless of how structor or instructors name(s).
the training function is organized or to whom as- If individual entries are then transcribed from
signed, is the person(s) who provide the training these sign-in sheets into an employee’s personal
qualified? The regulation does not offer the spec- training record, how is the accuracy of the tran-
ifics of what constitutes qualification, so the writer scription verified? Regardless of how training re-
offers a practical approach to qualification through cords are maintained – paper system or electronic
several questions: database – can one verify who has been trained
and who has not been trained on specific modules?
• Does the trainer have the technical expertise Review a sufficient number of training records to
required to train on the assigned subject? ensure that records are consistent, current, and ac-
• Does the trainer have knowledge of company curate. Looking at the records for at least three em-
specific SOPs to train on the assigned subject? ployees in at least three different departments
• Does the trainer have training expertise? would be a reasonable start.
If an electronic database is used, then confor-
These are not absolute requirements, but they mance with the applicable sections of 21 CFR11,
broadly represent the ideal. If any of these are ab- the regulation for Electronic Records and Electronic
sent, the effectiveness of the training may be less Signatures, will apply. Such a review and determi-
than optimal. nation are beyond the scope of this article.
Frequency of training and retraining is determin- Regardless of the method used to store training
ed by subject companies. Retraining may not be records, review enough of them to ensure that re-
routinely required for a process or operation that is cords are consistent, current, and accurate.
repeated with high frequency, such as once or Once you have verified that training occurred,
twice a week for much of a year. But the converse take a look at the materials used for the training.
creates a true training challenge. What if a particu- What did the learner see, listen to, or work with? Is
lar product is manufactured only once per year, or a handout available for your inspection? What
less, and further, there are difficult and unusual about videos, audio tapes, PowerPoint® presenta-
steps involved? Although a person may have been tions? Was a confirmation quiz used? Did all em-
trained on the procedures 18 months ago, is that ployees pass the quiz? All of these elements relate
person ready to make a batch today if that knowl- to the consistency of the training provided.

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
 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 [email protected].
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