Session 12 Sharon Strause.ppt

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Validation TrainingValidation TrainingSharon StrauseSharon Strause

Senior ConsultantSenior ConsultantEduQuestEduQuest

15th Annual Validation WeekOctober 28 – 30, 2009

Doubletree Hotel, Philadelphia, PA

EduQuest Education: Quality Engineering, Science, & Technology

Sharon Strause

15 years with thePharmaceutical industryPharmaceutical industry

Documentation, Computer System ValidationQuality Assurance ininformation management.

5 Years Consulting

10/29/09 Copyright 2009 EduQuest, Inc. 2

LifeScience IndustriesConsumer Product IndustriesSoftware Development Companies

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Where are you from?Where are you from?


AgendaAgenda

•• Validation TrainingValidation Training–– Why it’s importantWhy it’s important–– Why it s importantWhy it s important–– Who needs trainingWho needs training

•• Establishing a Training ProgramEstablishing a Training Program–– ElementsElements–– ConsiderationsConsiderations

•• Adult LearningAdult Learning


gg–– Tips & TricksTips & Tricks–– Techniques and approaches for successTechniques and approaches for success

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AgendaAgenda






Validation Validation –– Myths/TruthsMyths/Truths


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#1#1

•• Validation is a project related activity, which Validation is a project related activity, which l d b l l i dl d b l l i donce completed can be largely ignored. once completed can be largely ignored.


Truth Truth

Validation is a journey

Validation is best performedValidation is best performedwhen it is practiced in a lifewhen it is practiced in a life--cyclecycle

model using a cradlemodel using a cradle toto gravegrave

Not a destination!


model, using a cradlemodel, using a cradle--toto--gravegraveapproach. This provides the maximum approach. This provides the maximum

benefit in compliance and finance.benefit in compliance and finance.

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#2#2

•• Validation can be accomplished by a small cadre Validation can be accomplished by a small cadre f i di id l i h i i l i i hf i di id l i h i i l i i hof individuals with minimal intrusion on the rest of individuals with minimal intrusion on the rest

of the organizationof the organization


TruthTruth

Validation is everyone’s job. Each portion of the organizationEach portion of the organization

must contribute to the overallmust contribute to the overalleffort to insure success. Noeffort to insure success. No

single organization unit can hope to single organization unit can hope to i f ll h i [ di f ll h i [ d

y j


satisfy all the requirements [and satisfy all the requirements [and reap the benefits] alone.reap the benefits] alone.

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#3#3

•• Too much is made of validation in this Too much is made of validation in this industry. If we are GMP compliant, follow industry. If we are GMP compliant, follow procedures and make quality products, we procedures and make quality products, we shouldn’t have to spend as much time, money shouldn’t have to spend as much time, money and energy on validation! and energy on validation!


TruthTruth

Absolutely correct

Validation doesn’t replace the need Validation doesn’t replace the need to do any of those things, it to do any of those things, it

merelymerelyhelps s do them in a morehelps s do them in a more

y


helps us do them in a morehelps us do them in a morestructured way. It’s not the tailstructured way. It’s not the tail

which is wagging the dog, it is part which is wagging the dog, it is part of the dog! of the dog!

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Why ValidationWhy Validation

•• GXP’s GXP’s –– The Predicate RulesThe Predicate Rules

–– GMP GMP •• 21 CFR 110, 210, 211, 82021 CFR 110, 210, 211, 820

–– GLPGLP•• 21 CFR 5821 CFR 58

–– GCPGCP•• 21 CFR 50, 54, 56, 312, 314, 316, 601, 812, 81421 CFR 50, 54, 56, 312, 314, 316, 601, 812, 814


•• Part 11 Part 11 –– Covering All the FDA RegulationsCovering All the FDA Regulations

–– 21.CFR.1121.CFR.11

Why Validation Why Validation –– Other Other ConsiderationsConsiderations

•• HIPAAHIPAA•• OSHAOSHA•• EPAEPA•• DEADEA•• DODDOD


•• MHRA (formerly MCA)MHRA (formerly MCA)•• SarbanesSarbanes--OxleyOxley

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Types of Validation TrainingTypes of Validation Training

•• GxPGxP•• ProcessProcess•• CleaningCleaning•• PackagingPackaging•• Computer SystemComputer System


•• Procedures/ProcessesProcedures/Processes•• Audits (Internal/External)Audits (Internal/External)

Who Gets TrainedWho Gets Trained

EVERYONE!!

Start with Management


Start with Management

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AgendaAgenda






PlanningPlanning

“If you don’t know“If you don’t knowIf you don t know If you don t know where you are going, where you are going,

you are likely to end up you are likely to end up someplace else!”someplace else!”


Lewis CarrollLewis Carroll

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Elements of TrainingElements of Training

•• Plan, Plan, PlanPlan, Plan, Plan–– Establish objectivesEstablish objectives–– Design trainingDesign training–– Prepare materialsPrepare materials–– Determine size, seatingDetermine size, seating

•• Reserve the spaceReserve the space


pp

–– Notify participantsNotify participants

Elements of Training (2)Elements of Training (2)

•• ConductingConducting–– Rehearse, Rehearse, RehearseRehearse, Rehearse, Rehearse–– Room SetupRoom Setup–– Watch TimeWatch Time–– TrainTrain--thethe--TrainerTrainer

•• Adult learning principlesAdult learning principles•• Use humorUse humor•• Use brainstormingUse brainstorming•• Use visualsUse visuals•• Use vocal varietyUse vocal variety


•• Use meaningful gesturesUse meaningful gestures•• Do’s & Don’tsDo’s & Don’ts•• Handling a classHandling a class

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•• DocumentingDocumenting–– Name of courseName of course–– Date & Time of courseDate & Time of course–– Length of courseLength of course–– Description of courseDescription of course–– Name & Signature of TrainerName & Signature of Trainer


Name & Signature of TrainerName & Signature of Trainer–– Names & Signatures of AttendeesNames & Signatures of Attendees


•• FollowFollow--up strategyup strategy–– FeedbackFeedback–– FeedbackFeedback–– Reference MaterialsReference Materials–– NewslettersNewsletters–– Table ToppersTable Toppers–– Department/Safety MeetingsDepartment/Safety Meetings–– Measure & Monitor PerformanceMeasure & Monitor Performance

P A diP A di


–– Peer AuditsPeer Audits–– Current Events/Bulletin BoardsCurrent Events/Bulletin Boards–– ContestsContests

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ProverbProverb

I HEAR AND I FORGETI HEAR, AND I FORGET

I SEE, AND I REMEMBER

I DO, AND I UNDERSTAND


Consider…Consider…

•• Establishing a validation training programEstablishing a validation training program•• Partnering with QA, Regulatory, LegalPartnering with QA, Regulatory, Legal•• Finding good trainersFinding good trainers

–– InIn--househouse–– ExternalExternal

B i R l O i dB i R l O i d


•• Becoming Results OrientedBecoming Results Oriented–– DIRTFTDIRTFT

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Benefits of Validation TrainingBenefits of Validation Training

•• Validation Improves QualityValidation Improves Quality–– Compliance to Government RegulationsCompliance to Government Regulations–– Compliance to Company Quality PoliciesCompliance to Company Quality Policies–– Reduction in rejection, reworks, resamples, retests, Reduction in rejection, reworks, resamples, retests,

etc.etc.–– Increased throughput.Increased throughput.


g pg p

Benefits of Validation Training (2)Benefits of Validation Training (2)

•• Quality Improves ValueQuality Improves ValueQuality Improves ValueQuality Improves Value–– Reduced testing.Reduced testing.–– Increased ability for rapid investigations of errorIncreased ability for rapid investigations of error–– Fewer complaintsFewer complaints–– Cost AvoidanceCost Avoidance


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Benefits of Validation Training (3)Benefits of Validation Training (3)

•• Good Business PracticeGood Business Practice–– Increased ability to do rapid start up of systemsIncreased ability to do rapid start up of systems–– Increased ability to do easier scale up from Increased ability to do easier scale up from

developmentdevelopment–– Increased improvement for employee awareness Increased improvement for employee awareness --

“halo effect”“halo effect”


–– Increased ability for rapid automationIncreased ability for rapid automation

AgendaAgenda






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Tips & TricksTips & Tricks


Adult LearningAdult Learning

•• SelfSelf--directeddirectedT t CT t C ti i tti i t–– Treat as CoTreat as Co--participantsparticipants

–– Create environment of Create environment of mutual respectmutual respect

–– Involve them in setting Involve them in setting own objectivesown objectives


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One Way One Way –– Two WayTwo Way


Adult Learning (2)Adult Learning (2)

•• Bring ExperienceBring ExperienceD th i iD th i i

•• Learn to perform task or Learn to perform task or solve problemsolve problem–– Draw on their experienceDraw on their experience

–– Relate the learning to Relate the learning to their experiencestheir experiences

•• Note similarities and Note similarities and differencesdifferences

•• NowNow--OrientedOriented

solve problemsolve problem–– provide problemprovide problem--solving solving

activitiesactivities–– Minimize distractionsMinimize distractions–– Actively involve in Actively involve in

learning processlearning process


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•• Adults Adults -- Learn BestLearn BestD iD i–– DoingDoing

•• Adults Adults -- Learn SecondLearn Second–– SeeingSeeing

•• Adults Adults -- Learn ThirdLearn Third–– Reading & HearingReading & Hearing



•• Learning ModelLearning ModelSkillSkill–– SkillSkill

•• Ability to perform actionsAbility to perform actions

–– UnderstandingUnderstanding•• Why the specific action is being performed and the consequencesWhy the specific action is being performed and the consequences

–– AptitudeAptitude•• Individual predisposition to perform an actionIndividual predisposition to perform an action


–– AttitudeAttitude•• Individual motivation to do the actionIndividual motivation to do the action

Quartet Solutions America, Inc. – Allan Vanderheyden

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Set The StageSet The Stage


Creating EnvironmentCreating Environment

•• Allow Time for Allow Time for introductionsintroductionsintroductionsintroductions–– Establish CredentialsEstablish Credentials

•• Create interest in the Create interest in the subject mattersubject matter

•• Encourage participationEncourage participationffff


•• Use effective Use effective presentation techniquespresentation techniques

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Who are You?Who are You?


Creating interestCreating interest

•• Focus on relevantFocus on relevantIll h i iIll h i i•• Illustrate the positiveIllustrate the positive–– Avoid “overselling”Avoid “overselling”

•• Become advocate for Become advocate for changechange

•• Be sensitive Be sensitive


•• Be open to resistanceBe open to resistance•• Use “BrainUse “Brain--Teasers” or Teasers” or

“Intriguing Stories”“Intriguing Stories”

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BrainBrain--TeaserTeaser

GRFOOTAVE


BrainBrain--TeaserTeaser

GROUNDGROUND___________________

1 FOOTC S


24 INCHES1 YARD

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Intriguing StoryIntriguing Story

“DO I FEEL LUCKY TODAY???”


REMEMBERREMEMBER

•• TEACHING IS:TEACHING IS:–– PROCESS OF GETTING PEOPLE TO DO PROCESS OF GETTING PEOPLE TO DO

SOMETHINGSOMETHING–– MOTIVATING THE LEARNERMOTIVATING THE LEARNER

•• PARTICIPANTS ARE LEARNING WHEN:PARTICIPANTS ARE LEARNING WHEN:–– THEY LISTEN & WATCH INTENTLYTHEY LISTEN & WATCH INTENTLY


THEY LISTEN & WATCH INTENTLYTHEY LISTEN & WATCH INTENTLY–– RESPOND TO QUESTIONSRESPOND TO QUESTIONS–– ASK OWN QUESTIONSASK OWN QUESTIONS–– INITIATE DISCUSSIONINITIATE DISCUSSION

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Encourage ParticipationEncourage Participation

•• Be open to questions and Be open to questions and feedbackfeedbackfeedbackfeedback

•• Encourage learning by Encourage learning by doingdoing

•• Challenge with problemChallenge with problem--solving activitiessolving activitiesA l d EffA l d Eff


•• Applaud EffortApplaud Effort

ReviewReview

HOWAM

IDOING


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Check for UnderstandingCheck for Understanding

•• In module training, check each learner’s In module training, check each learner’s i d d li d d lprogress to insure ready to move to next moduleprogress to insure ready to move to next module

•• Watch for nonWatch for non--verbal cluesverbal clues–– Puzzled expressionsPuzzled expressions–– Folded ArmsFolded Arms–– DaydreamingDaydreaming


–– DaydreamingDaydreaming

Check for Understanding (2)Check for Understanding (2)

•• Turn nonTurn non--verbal signals into wordsverbal signals into wordsA k iA k i–– Ask questionsAsk questions

•• How are we doing?How are we doing?•• Are you with me?Are you with me?•• Is something not quite clear?Is something not quite clear?•• Shall I review that point again?Shall I review that point again?•• Are there any questions? orAre there any questions? or


•• Are there any questions? orAre there any questions? or•• Do you have any questions?Do you have any questions?

•• Use flipcharts to record questions & answersUse flipcharts to record questions & answers

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Techniques & Approaches for Techniques & Approaches for SuccessSuccess


PRESENTATION TECHNIQUES


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Basic PrinciplesBasic Principles

•• Don’t readDon’t readK t i lK t i l–– Know materialKnow material

–– Don’t lose your credibilityDon’t lose your credibility

•• Don’t slouch/swayDon’t slouch/sway–– Posture importantPosture important–– Move with purposeMove with purpose

Indi te onfiden eIndi te onfiden e


–– Indicate confidenceIndicate confidence


•• Watch AppearanceWatch AppearanceCl thCl th–– ClothesClothes

–– HairHair–– ShoesShoes

•• Dress for trainingDress for training–– FormalFormal

Rel edRel ed


–– RelaxedRelaxed–– CasualCasual

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•• Don’t watch the floorDon’t watch the floorE t t i t tE t t i t t–– Eye contact importantEye contact important

–– If need to check notes, If need to check notes, stop talkingstop talking

•• Don’t direct the Don’t direct the orchestraorchestra–– Watch use of arms andWatch use of arms and


Watch use of arms and Watch use of arms and handshands

–– Gestures should have Gestures should have purposepurpose

Basic principlesBasic principles

•• Don’t stay in the dark Don’t stay in the dark too longtoo longtoo longtoo long–– Detailed questions may Detailed questions may

mean lights onmean lights on–– Keep audience awakeKeep audience awake–– Note time of day and Note time of day and

when breaks are when breaks are


appropriateappropriate–– Watch your audienceWatch your audience

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Basic principles (2)Basic principles (2)

•• Answering questionsAnswering questions–– Move as close as possible to individualMove as close as possible to individual–– Maintain eye contact at all timesMaintain eye contact at all times–– Involve group by moving back, away from individual Involve group by moving back, away from individual

and shifting eye contact to entire groupand shifting eye contact to entire group•• Keep smilingKeep smiling


eep s geep s g–– Watch those eyes!!Watch those eyes!!

Basic principles (3)Basic principles (3)

•• Verbal CommunicationVerbal CommunicationV i P j tiV i P j ti–– Voice ProjectionVoice Projection

–– Voice SpeedVoice Speed–– Voice Inflection/ToneVoice Inflection/Tone–– Use of wordsUse of words–– Use of HumorUse of Humor–– Use of PausesUse of Pauses


Use of PausesUse of Pauses

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Practice, Practice, PracticePractice, Practice, Practice

•• Use a fullUse a full--length mirrorlength mirror•• Ch k r t tCh k r t t•• Check your eye contactCheck your eye contact•• Know your weaknesses Know your weaknesses --

Turn them into strengthsTurn them into strengths•• Watch what you eatWatch what you eat•• Know your audience or Know your audience or

assess early onassess early on


assess early onassess early on

QUESTIONSQUESTIONS


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Handling QuestionsHandling Questions

•• Questions are asked for a reason.Questions are asked for a reason.T li i i f i l ifi iT li i i f i l ifi i–– To elicit information or clarificationTo elicit information or clarification

–– Success is dependent on ability to discover reason Success is dependent on ability to discover reason behind questionbehind question

•• Listen carefully so understand the “real” Listen carefully so understand the “real” question or issuequestion or issue


•• Provide a response and offer reinforcementProvide a response and offer reinforcement•• Verify that your response is satisfactoryVerify that your response is satisfactory

Fair QuestionsFair Questions

•• Genuine questions to Genuine questions to gain informationgain informationgain informationgain information

•• Provide an immediate Provide an immediate responseresponse

•• If not prepared to If not prepared to answer:answer:

Admit don’t knowAdmit don’t know


–– Admit don t knowAdmit don t know–– Flipchart the Flipchart the

question/issuequestion/issue–– ResearchResearch–– FollowFollow--upup

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Unfair QuestionsUnfair Questions

•• Used to vent anger, fear, Used to vent anger, fear, frustrationfrustrationfrustrationfrustration

•• Important to address real Important to address real problemproblem

•• Be careful of where Be careful of where address address -- offoff--line better line better than onthan on lineline


than onthan on--line line

Disruptive SituationsDisruptive Situations

•• Use positive comments Use positive comments while asking for a changewhile asking for a changewhile asking for a change while asking for a change of behaviorof behavior

•• Deal with problem early Deal with problem early before course and class before course and class are offare off--tracktrack


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Tips for Disruptive SituationsTips for Disruptive Situations

•• Individual talks too Individual talks too •• Individual engages another Individual engages another i ii imuchmuch

–– “What does anyone else “What does anyone else think about this point?”think about this point?”

–– “Who else has some “Who else has some ideas?”ideas?”

•• Individual talks too longIndividual talks too long

person in conversationperson in conversation–– “Pardon me, we can’t hear “Pardon me, we can’t hear

what you and Sam are saying. what you and Sam are saying. Please share”Please share”

•• Challenging your ideas or Challenging your ideas or opinionsopinions–– Cite your sourcesCite your sources


•• Individual talks too longIndividual talks too long–– Interrupt at pauseInterrupt at pause–– Ask for summarizationAsk for summarization

Cite your sourcesCite your sources–– Ask group for their opinionAsk group for their opinion–– Acknowledge that has merit Acknowledge that has merit

and that you may need to do and that you may need to do some rethinkingsome rethinking

Team TeachingTeam Teaching

•• Review material with coReview material with co--instructor(s)instructor(s)

•• Establish mechanisms Establish mechanisms for providing feedbackfor providing feedbackinstructor(s)instructor(s)

•• Practice as teamPractice as team•• Share expectations with Share expectations with

each othereach other•• Don’t wander inDon’t wander in--andand--out out

hil h i hihil h i hi

for providing feedback for providing feedback during trainingduring training

•• Be mutually supportiveBe mutually supportive


while other is teachingwhile other is teaching

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Chinese ProverbChinese Proverb

I HEAR AND I FORGETI HEAR, AND I FORGET

I SEE, AND I REMEMBER

I DO, AND I UNDERSTAND


Q U E S T I O N S


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Thank YouThank You


[email protected]

Session 12 Sharon Strause.ppt

Documents

Transcript of Session 12 Sharon Strause.ppt