Novel applications For GMP
refresher training
Cathriona Duffy
Gowning re-qualification Computer based training
Aim:
To design and implement a refresher training module based on adult
learning principles that meets regulatory requirements.
Objectives:
• To redesign, validate & implement a GMP Gowning refresher
training module, that continues to meet regulatory requirements.
• To empower trainee’s using adult learning principles.
• To lessen impact on production by reducing time spent in
classroom.
• Establish views of target audience.
Why challenge & change our training method?
►
Potentially 3hr cycle time per
class.
►
Impacted production down-time.
►
Classroom based- Participants
were disempowered.
►
Participants were uncomfortable.
Expected deliverables:
►
Improved delivery (consistency of training).
►
Reduce cycle time.
►
Reduced scheduled down time.
►
Empowerment of target audience through application of adult learning
principles.
Voice of the customer: Adult learning principles
I would like if we can
have input into
designing the
training
I get really nervous & embarrassed
gowning with everyone watching
The training
takes too long
It would be great if
we could carry out
the training at our
own pace
From a production
schedule it would be
more beneficial if
we weren’t all
assessed together
Defined Requirements
CUSTOMER
Auditors
CUSTOMER’S
EXPRESSED
REQUIREMENTS
Accuracy & Detail.
TRANSLATED
REQUIREMENTS
Correct and supported
Sufficient information
based on regulations
Production area’s
with gowning
requirements
Site Quality
GMP Trainers
Records & traceability.
Track & trace that the
gowning training
requirement was met
& recorded within
timelines.
No negative business impact
and gowning quality is
sustained.
Resolution of issues
ASAP (e.g. on
duration, pass/fail rate)
Compliance with regulation
expectations.
Program that delivers
auditor expectations.
Quality of the training
program is sustained.
Program that delivers
auditor expectations.
Defined Requirements
CUSTOMER
CUSTOMER’S EXPRESSED
REQUIREMENTS
TRANSLATED
REQUIREMENTS
GMP Trainers
Trainer becomes facilitator
Track & trace that the
gowning training
requirement was met &
recorded within
timelines. Resolution of
issues at Skills
assessment.
Target audience
Adult learning principles i.e.
Program that resolves
target audience
identified issues
•Involvement
in program
design.
•Complete
the training at a
convenient time & at their
own pace.
•Skills
demonstration
assessment carried-out in a
1:1 situation as opposed to
classroom.
Programme/material demo
Out come
•Improved delivery (consistency of training/ facilitation role).
•Reduced cycle time (15 mins computer based training & certification,
8 mins Skills demonstration assessment).
•Reduced scheduled down time (computer based training &
certification can be completed to suit production- Skills demonstration
1:1 to suit production).
•Empowerment of target audience through application of adult
learning principles (Voice heard)
Feedback
I loved working at my own
pace
Its much easier to
fit my training in
around my work
schedule
I am more
comfortable in
a 1:1
assessment
As a nonroutine entrant I
can go back &
refresh myself,
by watching the
video
Good to see the
video was done in
the working
environment
Its interactive
informative, to the
point & practical
Liked the way the
multi-choice were
structured really
made me think
More effective to
“see” with video-A
practical insight not
always obvious in a
procedure
Challenge :
Alternative Training techniques
Is it possible to create a successful GMP refresher training
module that meets regulatory requirements?
Annual refresher GMP Training
►
Can be carried out without power point the key to this is organisation
facilitation & creativity)
►
Room set-up (tables ,colours, team card, collection point centre of room
team pack reusable)
►
Rules
►
7 exercises
Format
1.
2.
3.
4.
5.
6.
7.
Heart attack (10 GMP statements 5 correct 5 incorrect- Place pink sticky
hearts on the incorrect statement than write the correction on a sheet)
Blankety blank (10 GMP statements with missing words taken from an
envelop in the pack)
The long list (on a flipchart compile a list of all the ways in which we minimise
contamination)
Recto-verso ( cards with GMP statements on each side one side is correct
read & place the correct answer face up on the table)
Step by Step (from the envelop sort out the correct sequence to gown correctly
prior to entry to production areas)
Cross-words (GMP crossword www.eclipsecrosswords
www.toolsforeducators.com)
High impact GMP story to bring focus back to importance of GMP &
compliance e.g. death of babies given contaminated drips
Benefits
►
Sustained compliance
►
Team building
►
Safety net (immediate visual if something is incorrect)
►
Facilitation as opposed to classroom
►
Quick turn around of room
►
Fun, interest ,competition, enthusiasm
Feedback
I loved working with &
meeting people I wouldn’t
normally meet
I get bored with
presentationsThis gets me on
my feet & thinking
100%
participation
excellent
I can’t wait for
the next one!
Its Interactive &
Fun everyone’s
talking about it
Refresher training
covers information
we already knowso this way we get
to do the work!
Very organised &
Challenging –the
room was very
visual!
Liked the way we had
fun but still covered
the necessary
requirements
The story at the end
really made me
realise the impact my
work has on other
peoples lives
Thank-you