really trained or “reportedly” ” trained? what fda warning ...education-can be defined as the...
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Kristina Spitler Kristina Spitler Training ManagerTraining Manager
Almac Clinical ServicesAlmac Clinical ServicesAugust 22, 2007August 22, 2007
Really Trained orReally Trained or ““ReportedlyReportedly”” Trained?Trained?
What FDA Warning Letters Say AboutWhat FDA Warning Letters Say About the Effectiveness of Corporate Trainingthe Effectiveness of Corporate Training Programs and How to Develop Training Programs and How to Develop Training Programs Employees Want to AttendPrograms Employees Want to Attend
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Training TodayTraining Today
Recruiting employeesRecruiting employees $28,000$28,000Learning Mgmt System Learning Mgmt System $125,000$125,000Training costs per personTraining costs per person $10,000$10,000
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Employee who Employee who reallyreally knows what heknows what he’’s doings doing……
PRICELESS
Copyright © 2007, Kristina Spitler – Almac Clinical Services
There are some things There are some things money canmoney can’’t buyt buy
Effective TrainingEffective Training
For everything else, you better haveFor everything else, you better have……
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Truth or ConsequencesTruth or Consequences
Do you want to know the truth? Do you want to know the truth? …….or suffer the consequences?.or suffer the consequences?
Copyright © 2007, Kristina Spitler – Almac Clinical Services
The TruthThe Truth……
FDA observations and warnings related to FDA observations and warnings related to training are becoming more prevalent training are becoming more prevalent
“…“…SOP training in some cases indicated to have SOP training in some cases indicated to have covered a very large number of written covered a very large number of written procedures in one dayprocedures in one day…”…”“…“…no training requirement for the Supervisorno training requirement for the Supervisor…”…”“…“…inadequate traininginadequate training…”…”“…“…employees are not given training in the employees are not given training in the particular operations they performparticular operations they perform…”…”“…“…failure to document trainingfailure to document training…”…”“…“…failure to establish procedures for identifying failure to establish procedures for identifying training needstraining needs…”…”
Copyright © 2007, Kristina Spitler – Almac Clinical Services
……and the Consequencesand the Consequences
In 2005, after a wellIn 2005, after a well--publicized case, publicized case, a firm ultimately closed its doors in a firm ultimately closed its doors in the wake of serious compliance the wake of serious compliance deficiencies at its New Jersey facilitydeficiencies at its New Jersey facility2002 consent decree stemmed from 2002 consent decree stemmed from 483 observations that training was 483 observations that training was inadequate, excessive training was inadequate, excessive training was held on the same date, andheld on the same date, anduntrained personnel wereuntrained personnel weretraining otherstraining others
Copyright © 2007, Kristina Spitler – Almac Clinical Services
““ReportedlyReportedly”” trained?trained?
extract from a 2005 FDA warning letterextract from a 2005 FDA warning letterhttp://www.fda.gov/cder/warn/2005/320-05-01.pdf
Copyright © 2007, Kristina Spitler – Almac Clinical Services
““ReportedlyReportedly”” trained?trained?
extract from the same 2005 FDA warning letterextract from the same 2005 FDA warning letter
http://www.fda.gov/cder/warn/2005/320-05-01.pdf
Copyright © 2007, Kristina Spitler – Almac Clinical Services
The Conclusion
“These observations indicate a serious deficiency in the
methods and adequacy of your training efforts.”
extract from the same 2005 FDA warning letterextract from the same 2005 FDA warning letter
http://www.fda.gov/cder/warn/2005/320-05-01.pdf
Copyright © 2007, Kristina Spitler – Almac Clinical Services
extract from a 2004 FDA warning letterextract from a 2004 FDA warning letter
Even earlierEven earlier……..
http://www.fda.gov/foi/warning_letters/archive/g4851d.pdf
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If employees don’t transfer the skills and knowledge from the training to their jobs, you’re
risking patient safety.
The Bottom LineThe Bottom Line
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Your Training FocusYour Training Focus
Two major areas on which to focus:Two major areas on which to focus:Utilizing effective training Utilizing effective training methodsmethodsEvaluating training adequacy and Evaluating training adequacy and effectivenesseffectiveness
Effective teaching may be the hardest job there is.
William Glasser
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Training CAPA CycleTraining CAPA Cycle
Retraining = common corrective Retraining = common corrective actionactionEffective training = Excellent Effective training = Excellent preventive actionpreventive actionIdentifying the root causes of Identifying the root causes of ineffective trainingineffective training
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Root Causes of Ineffective Root Causes of Ineffective TrainingTraining
MotiveMotiveMethodsMethodsIntensityIntensityEvaluationEvaluation
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Cause #1Cause #1 -- MotiveMotive
Completion Completion –– Training is documentedTraining is documented
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MotiveMotive
ORORCompetency Competency –– Employee truly Employee truly
understands the job understands the job and performs it correctlyand performs it correctly
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The GitThe Git--RR--Done MentalityDone Mentality
Motive / CommitmentMotive / CommitmentproblemproblemDocumentation is the Documentation is the motivemotive
““self trainingself training””Read and signRead and signEE--learning trapslearning trapsUnrealistic Unrealistic requirementsrequirements
Copyright © 1999-2007 Git-R-Done Productions / Team Pozer Productions
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Efficient vs. EffectiveEfficient vs. Effective
Who would you rather have pack your Who would you rather have pack your parachute parachute -- the the efficientefficient guy or the guy or the effectiveeffective guy?guy?Value effectivenessValue effectivenessover efficiencyover efficiency
Lives are at stakeLives are at stake
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Cause #2Cause #2 -- MethodsMethods
How are training methods How are training methods determined?determined?What methods really work What methods really work -- with with adultsadultsLecture and Reading Lecture and Reading ……..oh boy!..oh boy!
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““CoveringCovering”” the materialthe material
Memorization is what we resort to when
what we are learning makes no sense.
Anonymous
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Retention RatesRetention Rates
Lecture Lecture 5%5%ReadingReading 10%10%AudiovisualsAudiovisuals 20%20%DemonstrationDemonstration 30%30%DiscussionDiscussion 50%50%Practice by doingPractice by doing 75%75%Teaching othersTeaching others 90%90%
ItIt’’s not what s not what you teach that you teach that
countscounts----itit’’s what s what they take they take
away.away.
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Educational DomainsEducational Domains
Cognitive: Cognitive: mental skillsmental skillsPsychomotor: Psychomotor: physical skillsphysical skillsAffective: Affective: emotional growthemotional growth
KnowledgeKnowledge
SkillsSkills
AttitudeAttitude
Copyright © 2007, Kristina Spitler – Almac Clinical Services
What is learning?What is learning?
"In its broadest sense, learning can be defined as a "In its broadest sense, learning can be defined as a process of progressive change fromprocess of progressive change from ignorance to knowledgeignorance to knowledge, , from inability to competencefrom inability to competence, and from , and from indifference to understandingindifference to understanding
....In much the same manner, instruction....In much the same manner, instruction--or or educationeducation--can be defined as the means by which can be defined as the means by which we systematize the situations, conditions, tasks we systematize the situations, conditions, tasks materials, and opportunities by which learners materials, and opportunities by which learners acquire new or different ways of acquire new or different ways of thinking, feeling, and doingthinking, feeling, and doing." ."
Cameron Fincher, "Learning Theory and Research," in Cameron Fincher, "Learning Theory and Research," in Teaching and Learning in Teaching and Learning in the College Classroomthe College Classroom, edited by Kenneth A. Feldman and Michael Paulson, Ashe , edited by Kenneth A. Feldman and Michael Paulson, Ashe Reader Series, Needham, MA: Reader Series, Needham, MA: GinnGinn Press, 1994.Press, 1994.
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Laws of LearningLaws of Learning
Law of ExerciseLaw of ExercisePeople learn by DOING!People learn by DOING!
Law of ReadinessLaw of ReadinessUnless people are ready, willing, and able Unless people are ready, willing, and able to learn, no learning will take place.to learn, no learning will take place.
Law of AssociationLaw of AssociationTie new information to something known, Tie new information to something known, whenever possible. whenever possible.
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Audience AttentionAudience Attention
Minimize attention “troughs” by changing activities and methods often. Make sure that vital points are
communicated in multiple ways using various senses.
Ideal
% a
ttent
ion
Time
Actual
% a
ttent
ion
100% 100%
Time
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Perceiving InformationPerceiving Information Learning StyleLearning Style
VisualVisualAuditoryAuditoryKinestheticKinestheticCombinationCombination
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Prepare Inform Practice
Evaluate
The Training PipelineThe Training Pipeline
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EE--learning learning –– Blessing or CurseBlessing or Curse
Technical Technical resistanceresistance““CheatingCheating”” the the systemsystemLimited Limited interaction and interaction and ability to ask ability to ask questionsquestions
CostCost--effectiveeffectiveTakes less timeTakes less timePracticalPracticalStandardizedStandardizedEngagingEngaging
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Read and SignRead and Sign
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Cause #3Cause #3 -- IntensityIntensity
Training with the wrong intensity is Training with the wrong intensity is closely linked to training with the closely linked to training with the wrong methodwrong methodAppropriate toAppropriate totask task intensityintensityAppropriate toAppropriate topersonnel personnel intensityintensity
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TMI TMI –– Too Much InformationToo Much Information
““Information is gushing toward your Information is gushing toward your brain like a fire hose aimed at a brain like a fire hose aimed at a teacup.teacup.”” –– DilbertDilbert
“…“…employee had a trainingemployee had a trainingrecord showing training onrecord showing training on6767 written procedures in one day.written procedures in one day.””–– FDA 483FDA 483
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Keep it simpleKeep it simple
The most valuable of all talents is The most valuable of all talents is that of never using two words when that of never using two words when one will do. one will do. ---- Thomas JeffersonThomas Jefferson
The most valuable of all talents is that of never The most valuable of all talents is that of never using two words when one will do. using two words when one will do. (minus 4 words)(minus 4 words)
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Six Levels of LearningSix Levels of Learning
BloomBloom’’s Taxonomy s Taxonomy –– developed by developed by Benjamin Bloom in the 1950sBenjamin Bloom in the 1950sQualitatively expressing different kinds of Qualitatively expressing different kinds of thinkingthinking
Knowledge (remembering)Knowledge (remembering)Comprehension (understanding)Comprehension (understanding)Application (applying)Application (applying)Analysis (analyzing)Analysis (analyzing)Synthesis (creating)Synthesis (creating)Evaluation (evaluating)Evaluation (evaluating)
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Proper intensity to task ratioProper intensity to task ratio
“…“…newly recruited personnel should newly recruited personnel should receive training receive training appropriateappropriate to the to the duties assigned to them.duties assigned to them.””““Continuing training should also be Continuing training should also be given, and itgiven, and it’’s s practical effectiveness practical effectiveness should beshould be periodically assessedperiodically assessed..””
EU Guidance on Good Manufacturing Practice EU Guidance on Good Manufacturing Practice -- Section 2.9Section 2.9
Copyright © 2007, Kristina Spitler – Almac Clinical Services
if your employees are if your employees are ““reallyreally””trained trained ……
How do you evaluateHow do you evaluate……
Copyright © 2007, Kristina Spitler – Almac Clinical Services
or or ““reportedlyreportedly”” trained?trained?
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Cause #4Cause #4 -- EvaluationEvaluation
KirkpatrickKirkpatrick’’s Model s Model ––developed by Donald developed by Donald Kirkpatrick in 1959Kirkpatrick in 1959Info from each level Info from each level serves as a base for next serves as a base for next levellevelLevel 1:Level 1:ReactionsReactionsSmile sheetSmile sheet
React
ions
Lear
ningTr
ansf
er
Result
s
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Measuring Reaction Measuring Reaction
When you are When you are in deep trouble, in deep trouble, say nothing, say nothing, and try to look and try to look like you know like you know what youwhat you’’re re doing!doing!
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Measuring LearningMeasuring Learning
Level 2:Level 2:LearningLearningAssess extent Assess extent of knowledgeof knowledgeQuizzesQuizzesQuestionsQuestionsPrePre--test and test and postpost--testtest
Reactions
Learning
Transfer
Results
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Hear, Understand, ApplyHear, Understand, Apply
Did they hear you correctly?Did they hear you correctly?Repeat backRepeat back
Do they understand?Do they understand?QuestionsQuestions
Can they apply the information?Can they apply the information?Demonstrate Demonstrate
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Measuring TransferMeasuring Transfer
Level 3:Level 3:TransferTransferBehavior on Behavior on the jobthe jobError ratiosError ratiosReworkReworkComplaintsComplaintsObservationsObservations
Reactions
Learning
Transfer
Results
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Ensuring knowledge transferEnsuring knowledge transfer
““When operating in a robust quality When operating in a robust quality system environment, it is important system environment, it is important that supervisory managers ensure that supervisory managers ensure that skills gained from training be that skills gained from training be incorporated into dayincorporated into day--toto--day day performanceperformance..””
Pharmaceutical Pharmaceutical cGMPscGMPs: Integrating : Integrating FDAFDA’’s Risks Risk--Based ApproachBased Approach
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Measuring ResultsMeasuring Results
Level 4:Level 4:ResultsResultsBottom lineBottom lineQuantitativeQuantitativeTie to Tie to business business initiativesinitiatives Reactions
Learning
Transfer
Results
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Measure to the right levelMeasure to the right level
Objectives drive measurement levelObjectives drive measurement levelDefine outcomesDefine outcomesDetermine intensityDetermine intensityBuild measurements on one anotherBuild measurements on one another
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Continually Evaluating TrainingContinually Evaluating Training
“…“…continued training is critical to continued training is critical to ensure that the employees ensure that the employees remainremainproficientproficient in their operational in their operational functions and in their understanding functions and in their understanding of of cGMPcGMP regulations.regulations.””
Pharmaceutical Pharmaceutical cGMPscGMPs: Integrating : Integrating FDAFDA’’s Risks Risk--Based ApproachBased Approach
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Evaluation from start to finishEvaluation from start to finish
““Under a quality system, Under a quality system, managers managers are expectedare expected to establish training to establish training programs that include the programs that include the following:following:
Evaluation of training needsEvaluation of training needsProvision of training to satisfy these needsProvision of training to satisfy these needsEvaluation of effectiveness of trainingEvaluation of effectiveness of trainingDocumentation of training and/or Documentation of training and/or rere--training.training.”” Pharmaceutical Pharmaceutical cGMPscGMPs: Integrating : Integrating
FDAFDA’’s Risks Risk--Based ApproachBased Approach
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Recipe for SuccessRecipe for Success
Motive / CommitmentMotive / CommitmentMethodsMethodsIntensity Intensity EvaluationEvaluation
Effective TrainingEffective Training
Copyright © 2007, Kristina Spitler – Almac Clinical Services
Contact Info:Contact Info:Kristina Spitler Kristina Spitler –– Training ManagerTraining Manager
Almac Clinical ServicesAlmac Clinical [email protected]@almacgroup.com
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