Validation Training

Transcription

Validation Training

10/12/2009
Validation Training
Sharon Strause
Senior Consultant
EduQuest
EduQuest
Education: Quality Engineering, Science, & Technology
15th Annual Validation Week
October 28 – 30, 2009
Doubletree Hotel, Philadelphia, PA
Sharon Strause
z15
years with the
Pharmaceutical industry
zDocumentation,
zComputer System Validation
zQuality Assurance in
information management.
z5 Years Consulting
zLifeScience Industries
zConsumer Product Industries
zSoftware Development Companies
10/29/09
Copyright 2009 EduQuest, Inc.
2
1
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Where are you from?
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3
Agenda
• Validation Training
– Why it
it’ss important
– Who needs training
• Establishing a Training Program
– Elements
– Considerations
• Adult Learningg
– Tips & Tricks
– Techniques and approaches for success
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4
2
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Agenda
– Why it
it’ss important
– Elements
– Considerations
• Adult Learningg
– Tips & Tricks
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5
Validation – Myths/Truths
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3
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#1
• Validation is a project related activity, which
once completed
l d can be
b llargely
l iignored.
d
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7
Truth
Validation is a journey
Not a destination!
Validation is best performed
when it is practiced in a lifelife-cycle
model,
model using a cradlecradle-to
to--grave
approach. This provides the maximum
benefit in compliance and finance.
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4
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#2
• Validation can be accomplished by a small cadre
off individuals
i di id l with
i h minimal
i i l intrusion
i
i on the
h rest
of the organization
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9
Truth
Validation is everyone’s
y
job.
j
Each portion of the organization
must contribute to the overall
effort to insure success. No
single organization unit can hope to
satisfy
i f allll the
h requirements
i
[and
[ d
reap the benefits] alone.
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10
5
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#3
• Too much is made of validation in this
industry. If we are GMP compliant, follow
procedures and make quality products, we
shouldn’t have to spend as much time, money
and energy on validation!
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11
Truth
Absolutelyy correct
Validation doesn’t replace the need
to do any of those things, it
merely
helps uss do them in a more
structured way. It’s not the tail
which is wagging the dog, it is part
of the dog!
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Why Validation
• GXP’s – The Predicate Rules
– GMP
• 21 CFR 110, 210, 211, 820
– GLP
• 21 CFR 58
– GCP
• 21 CFR 50, 54, 56, 312, 314, 316, 601, 812, 814
• Part 11 – Covering All the FDA Regulations
– 21.CFR.11
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•
•
•
•
•
•
•
13
Why Validation – Other
Considerations
HIPAA
OSHA
EPA
DEA
DOD
MHRA (formerly MCA)
Sarbanes--Oxley
Sarbanes
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Types of Validation Training
•
•
•
•
•
•
•
GxP
Process
Cleaning
Packaging
Computer System
Procedures/Processes
Audits (Internal/External)
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Who Gets Trained
EVERYONE!!
Start with Management
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Agenda
– Why it
it’ss important
– Elements
– Considerations
• Adult Learningg
– Tips & Tricks
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Planning
“If
If you don
don’tt know
where you are going,
you are likely to end up
someplace else!”
Lewis Carroll
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9
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Elements of Training
• Plan, Plan, Plan
–
–
–
–
Establish objectives
Design training
Prepare materials
Determine size, seating
• Reserve the space
p
– Notify participants
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Elements of Training (2)
• Conducting
–
–
–
–
Rehearse, Rehearse, Rehearse
Room Setup
Watch Time
Train--theTrain
the-Trainer
•
•
•
•
•
•
•
•
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Adult learning principles
Use humor
Use brainstorming
Use visuals
Use vocal variety
Use meaningful gestures
Do’s & Don’ts
Handling a class
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• Documenting
–
–
–
–
–
–
Name of course
Date & Time of course
Length of course
Description of course
Name & Signature of Trainer
Names & Signatures of Attendees
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• Follow
Follow--up strategy
–
–
–
–
–
–
–
–
–
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Feedback
Reference Materials
Newsletters
Table Toppers
Department/Safety Meetings
Measure & Monitor Performance
P Audits
Peer
A di
Current Events/Bulletin Boards
Contests
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11
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Proverb
I HEAR,
HEAR AND I FORGET
I SEE, AND I REMEMBER
I DO, AND I UNDERSTAND
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Consider…
• Establishing a validation training program
• Partnering with QA, Regulatory, Legal
• Finding good trainers
– In
In--house
– External
• Becoming
B
i Results
R l Oriented
Oi
d
– DIRTFT
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Benefits of Validation Training
• Validation Improves Quality
– Compliance to Government Regulations
– Compliance to Company Quality Policies
– Reduction in rejection, reworks, resamples, retests,
etc.
– Increased throughput.
g p
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Benefits of Validation Training (2)
• Quality Improves Value
–
–
–
–
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Reduced testing.
Increased ability for rapid investigations of error
Fewer complaints
Cost Avoidance
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Benefits of Validation Training (3)
• Good Business Practice
– Increased ability to do rapid start up of systems
– Increased ability to do easier scale up from
development
– Increased improvement for employee awareness “halo effect”
– Increased ability for rapid automation
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Agenda
– Why it
it’ss important
– Elements
– Considerations
• Adult Learningg
– Tips & Tricks
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14
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Tips & Tricks
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Adult Learning
• Self
Self--directed
– Treat
T t as CoCo
C -participants
ti i t
– Create environment of
mutual respect
– Involve them in setting
own objectives
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One Way – Two Way
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Adult Learning (2)
• Bring Experience
– Draw
D
on their
th i experience
i
– Relate the learning to
their experiences
• Note similarities and
differences
• Now
Now--Oriented
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• Learn to perform task or
solve problem
– provide problem
problem--solving
activities
– Minimize distractions
– Actively involve in
learning process
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16
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Adult Learning (3)
• Adults - Learn Best
– Doing
D i
• Adults - Learn Second
– Seeing
• Adults - Learn Third
– Reading & Hearing
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Adult Learning (4)
• Learning Model
– Skill
• Ability to perform actions
– Understanding
• Why the specific action is being performed and the consequences
– Aptitude
• Individual predisposition to perform an action
– Attitude
• Individual motivation to do the action
Quartet Solutions America, Inc. – Allan Vanderheyden
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Set The Stage
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Creating Environment
• Allow Time for
introductions
– Establish Credentials
• Create interest in the
subject matter
• Encourage participation
• Use effective
ff
presentation techniques
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Who are You?
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Creating interest
• Focus on relevant
• Illustrate
Ill
the
h positive
ii
– Avoid “overselling”
• Become advocate for
change
• Be sensitive
• Be open to resistance
• Use “Brain
“Brain--Teasers” or
“Intriguing Stories”
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Brain--Teaser
Brain
GRFOOTAVE
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Brain--Teaser
Brain
GROUND
___________________
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1 FOOT
24 INCHES
C S
1 YARD
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Intriguing Story
“DO I FEEL LUCKY TODAY???”
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REMEMBER
• TEACHING IS:
– PROCESS OF GETTING PEOPLE TO DO
SOMETHING
– MOTIVATING THE LEARNER
• PARTICIPANTS ARE LEARNING WHEN:
–
–
–
–
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THEY LISTEN & WATCH INTENTLY
RESPOND TO QUESTIONS
ASK OWN QUESTIONS
INITIATE DISCUSSION
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Encourage Participation
• Be open to questions and
feedback
• Encourage learning by
doing
• Challenge with problem
problem-solving activities
• Applaud
A l d Eff
Effort
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Review
HOW
AM
I
DOING
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Check for Understanding
• In module training, check each learner’s
progress to insure
i
ready
d to move to next module
d l
• Watch for nonnon-verbal clues
– Puzzled expressions
– Folded Arms
– Daydreaming
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Check for Understanding (2)
• Turn nonnon-verbal signals into words
– Ask
A k questions
i
•
•
•
•
•
•
How are we doing?
Are you with me?
Is something not quite clear?
Shall I review that point again?
Are there any questions? or
Do you have any questions?
• Use flipcharts to record questions & answers
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Techniques & Approaches for
Success
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PRESENTATION TECHNIQUES
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Basic Principles
• Don’t read
– Know
K
material
t i l
– Don’t lose your credibility
• Don’t slouch/sway
– Posture important
– Move with purpose
– Indicate
Indi te confidence
onfiden e
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Basic Principles
• Watch Appearance
– Clothes
Cl th
– Hair
– Shoes
• Dress for training
– Formal
– Relaxed
Rel ed
– Casual
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Basic Principles
• Don’t watch the floor
– Eye
E contact
t t important
i
t t
– If need to check notes,
stop talking
• Don’t direct the
orchestra
– Watch use of arms and
hands
– Gestures should have
purpose
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Basic principles
• Don’t stay in the dark
too long
– Detailed questions may
mean lights on
– Keep audience awake
– Note time of day and
when breaks are
appropriate
– Watch your audience
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Basic principles (2)
• Answering questions
– Move as close as possible to individual
– Maintain eye contact at all times
– Involve group by moving back, away from individual
and shifting eye contact to entire group
• Keep
eep smiling
s
g
– Watch those eyes!!
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Basic principles (3)
• Verbal Communication
–
–
–
–
–
–
10/29/09
V i P
Voice
Projection
j ti
Voice Speed
Voice Inflection/Tone
Use of words
Use of Humor
Use of Pauses
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10/12/2009
Practice, Practice, Practice
• Use a full
full--length mirror
• Check
Ch k yourr eye contact
t t
• Know your weaknesses Turn them into strengths
• Watch what you eat
• Know your audience or
assess early on
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QUESTIONS
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Handling Questions
• Questions are asked for a reason.
– To
T elicit
li i information
i f
i or clarification
l ifi i
– Success is dependent on ability to discover reason
behind question
• Listen carefully so understand the “real”
question or issue
• Provide a response and offer reinforcement
• Verify that your response is satisfactory
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Fair Questions
• Genuine questions to
gain information
• Provide an immediate
response
• If not prepared to
answer:
– Admit don
don’tt know
– Flipchart the
question/issue
– Research
– Follow
Follow--up
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Unfair Questions
• Used to vent anger, fear,
frustration
• Important to address real
problem
• Be careful of where
address - offoff-line better
than on
on--line
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Disruptive Situations
• Use positive comments
while asking for a change
of behavior
• Deal with problem early
before course and class
are offoff-track
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Tips for Disruptive Situations
• Individual engages another
person in
i conversation
i
• Individual talks too
much
– “What does anyone else
think about this point?”
– “Who else has some
ideas?”
• Individual talks too long
– Interrupt at pause
– Ask for summarization
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– “Pardon me, we can’t hear
what you and Sam are saying.
Please share”
• Challenging your ideas or
opinions
– Cite your sources
– Ask group for their opinion
– Acknowledge that has merit
and that you may need to do
some rethinking
61
Team Teaching
• Review material with cocoinstructor(s)
• Practice as team
• Share expectations with
each other
• Don’t wander in
in--andand-out
while
hil other
h iis teaching
hi
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• Establish mechanisms
for providing feedback
during training
• Be mutually supportive
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31
10/12/2009
Chinese Proverb
I HEAR,
HEAR AND I FORGET
I SEE, AND I REMEMBER
I DO, AND I UNDERSTAND
10/29/09
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QUESTIONS
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32
10/12/2009
Thank You
[email protected]
10/29/09
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33

Validation Training

Transcription

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