Really Trained or Reportedly Trained What FDA Warning

Training Today Recruiting employees n Learning Mgmt System n Training costs person n Copyright

Employee who really knows what he’s doing… PRICELESS Copyright © 2007, Kristina Spitler –

There are some things money can’t buy For everything else, you better have… Effective

Truth or Consequences n Do you want to know the truth? …. or suffer

The Truth… FDA observations and warnings related to training are becoming more prevalent n

…and the Consequences In 2005, after a well-publicized case, a firm ultimately closed its

“Reportedly” trained? extract from a 2005 FDA warning letter http: //www. fda. gov/cder/warn/2005/320 -05

“Reportedly” trained? extract from the same 2005 FDA warning letter http: //www. fda. gov/cder/warn/2005/320

The Conclusion “These observations indicate a serious deficiency in the methods and adequacy of

Even earlier…. extract from a 2004 FDA warning letter http: //www. fda. gov/foi/warning_letters/archive/g 4851

The Bottom Line If employees don’t transfer the skills and knowledge from the training

Your Training Focus n Two major areas on which to focus: n Utilizing effective

Training CAPA Cycle Retraining = common corrective action n Effective training = Excellent preventive

Root Causes of Ineffective Training Motive n Methods n Intensity n Evaluation n Copyright

Cause #1 - Motive n Completion – Training is documented Copyright © 2007, Kristina

Motive OR n Competency – Employee truly understands the job and performs it correctly

The Git-R-Done Mentality Motive / Commitment problem n Documentation is the motive n n

Efficient vs. Effective Who would you rather have pack your parachute - the efficient

Cause #2 - Methods How are training methods determined? n What methods really work

“Covering” the material Memorization is what we resort to when what we are learning

Retention Rates n Lecture 5% n Reading 10% n Audiovisuals 20% n Demonstration 30%

Educational Domains Cognitive: mental skills n Psychomotor: physical skills n Affective: emotional growth n

What is learning? "In its broadest sense, learning can be defined as a process

Laws of Learning n n n Law of Exercise n People learn by DOING!

Audience Attention Ideal 100% % attention 100% Actual Time Minimize attention “troughs” by changing

Perceiving Information Learning Style Visual n Auditory n Kinesthetic n Combination n Copyright ©

The Training Pipeline Prepare Copyright © 2007, Kristina Spitler – Almac Clinical Services Inform

E-learning – Blessing or Curse n n n Cost-effective Takes less time Practical Standardized

Read and Sign Copyright © 2007, Kristina Spitler – Almac Clinical Services

Cause #3 - Intensity Training with the wrong intensity is closely linked to training

TMI – Too Much Information n “Information is gushing toward your brain like a

Keep it simple n The most valuable of all talents is that of never

Six Levels of Learning n n Bloom’s Taxonomy – developed by Benjamin Bloom in

Proper intensity to task ratio “…newly recruited personnel should receive training appropriate to the

How do you evaluate… n if your employees are “really” trained … Copyright ©

n or “reportedly” trained? Copyright © 2007, Kristina Spitler – Almac Clinical Services

Copyright © 2007, Kristina Spitler – Almac Clinical Services Re ac tio ns Le

Measuring Reaction n When you are in deep trouble, say nothing, and try to

Measuring Learning Level 2: Learning n Assess extent of knowledge n Quizzes n Questions

Hear, Understand, Apply n Did they hear you correctly? n Repeat n back Do

Measuring Transfer Level 3: Transfer n Behavior on the job n Error ratios n

Ensuring knowledge transfer n “When operating in a robust quality system environment, it is

Measuring Results Level 4: Results n Bottom line n Quantitative n Tie to business

Measure to the right level Objectives drive measurement level n Define outcomes n Determine

Continually Evaluating Training n “…continued training is critical to ensure that the employees remain

Evaluation from start to finish n “Under a quality system, managers are expected to

Recipe for Success Motive / Commitment n Methods n Intensity n Evaluation n Effective

Contact Info: Kristina Spitler – Training Manager Almac Clinical Services kristina. spitler@almacgroup. com 919

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Really Trained or “Reportedly” Trained? What FDA Warning Letters Say About the Effectiveness of Corporate Training Programs and How to Develop Training Programs Employees Want to Attend Copyright © 2007, Kristina Spitler – Almac Clinical Services Kristina Spitler Training Manager Almac Clinical Services August 22, 2007

The Truth… FDA observations and warnings related to training are becoming more prevalent n n n “…SOP training in some cases indicated to have covered a very large number of written procedures in one day…” “…no training requirement for the Supervisor…” “…inadequate training…” “…employees are not given training in the particular operations they perform…” “…failure to document training…” “…failure to establish procedures for identifying training needs…” Copyright © 2007, Kristina Spitler – Almac Clinical Services

…and the Consequences In 2005, after a well-publicized case, a firm ultimately closed its doors in the wake of serious compliance deficiencies at its New Jersey facility n 2002 consent decree stemmed from 483 observations that training was inadequate, excessive training was held on the same date, and untrained personnel were training others n 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 letter http: //www. fda. gov/cder/warn/2005/320 -05 -01. pdf Copyright © 2007, Kristina Spitler – Almac Clinical Services

Your Training Focus n Two major areas on which to focus: n Utilizing effective training methods n Evaluating training adequacy and effectiveness Effective teaching may be the hardest job there is. William Glasser Copyright © 2007, Kristina Spitler – Almac Clinical Services

Training CAPA Cycle Retraining = common corrective action n Effective training = Excellent preventive action n Identifying the root causes of ineffective training n Copyright © 2007, Kristina Spitler – Almac Clinical Services

The Git-R-Done Mentality Motive / Commitment problem n Documentation is the motive n n “self training” n Read and sign n E-learning traps n Unrealistic requirements Copyright © 2007, Kristina Spitler – Almac Clinical Services Copyright © 1999 -2007 Git-R-Done Productions / Team Pozer Productions

Efficient vs. Effective Who would you rather have pack your parachute - the efficient guy or the effective guy? n Value effectiveness over efficiency n Lives are at stake n Copyright © 2007, Kristina Spitler – Almac Clinical Services

Retention Rates n Lecture 5% n Reading 10% n Audiovisuals 20% n Demonstration 30% n Discussion 50% n Practice by doing 75% n Teaching others 90% Copyright © 2007, Kristina Spitler – Almac Clinical Services It’s not what you teach that counts --it’s what they take away.

What is learning? "In its broadest sense, learning can be defined as a process of progressive change from ignorance to knowledge, from inability to competence, and from indifference to understanding. . In much the same manner, instruction-or education-can be defined as the means by which we systematize the situations, conditions, tasks materials, and opportunities by which learners acquire new or different ways of thinking, feeling, and doing. " n Cameron Fincher, "Learning Theory and Research, " in Teaching and Learning in the College Classroom, edited by Kenneth A. Feldman and Michael Paulson, Ashe Reader Series, Needham, MA: Ginn Press, 1994. Copyright © 2007, Kristina Spitler – Almac Clinical Services

Laws of Learning n n n Law of Exercise n People learn by DOING! Law of Readiness n Unless people are ready, willing, and able to learn, no learning will take place. Law of Association n Tie new information to something known, whenever possible. Copyright © 2007, Kristina Spitler – Almac Clinical Services

Audience Attention Ideal 100% % attention 100% Actual Time Minimize attention “troughs” by changing activities and methods often. Make sure that vital points are communicated in multiple ways using various senses. Copyright © 2007, Kristina Spitler – Almac Clinical Services

E-learning – Blessing or Curse n n n Cost-effective Takes less time Practical Standardized Engaging Copyright © 2007, Kristina Spitler – Almac Clinical Services n n n Technical resistance “Cheating” the system Limited interaction and ability to ask questions

Cause #3 - Intensity Training with the wrong intensity is closely linked to training with the wrong method n Appropriate to task intensity n Appropriate to personnel intensity n © 1998 -2007 All. Posters. com Copyright © 2007, Kristina Spitler – Almac Clinical Services

TMI – Too Much Information n “Information is gushing toward your brain like a fire hose aimed at a teacup. ” – Dilbert n “…employee had a training record showing training on 67 written procedures in one day. ” – FDA 483 Copyright © 2007, Kristina Spitler – Almac Clinical Services

Keep it simple n The most valuable of all talents is that of never using two words when one will do. -- Thomas Jefferson n The most valuable of all talents is that of never using two words when one will do. (minus 4 words) Copyright © 2007, Kristina Spitler – Almac Clinical Services

Six Levels of Learning n n Bloom’s Taxonomy – developed by Benjamin Bloom in the 1950 s Qualitatively expressing different kinds of thinking n n n Knowledge (remembering) Comprehension (understanding) Application (applying) Analysis (analyzing) Synthesis (creating) Evaluation (evaluating) Copyright © 2007, Kristina Spitler – Almac Clinical Services

Proper intensity to task ratio “…newly recruited personnel should receive training appropriate to the duties assigned to them. ” n “Continuing training should also be given, and it’s practical effectiveness should be periodically assessed. ” n EU Guidance on Good Manufacturing Practice - Section 2. 9 Copyright © 2007, Kristina Spitler – Almac Clinical Services

Copyright © 2007, Kristina Spitler – Almac Clinical Services Re ac tio ns Le ar ni ng Tr an sf er Re Kirkpatrick’s Model – developed by Donald Kirkpatrick in 1959 n Info from each level serves as a base for next level n Level 1: Reactions n Smile sheet n su l ts Cause #4 - Evaluation

Measuring Learning Level 2: Learning n Assess extent of knowledge n Quizzes n Questions n Pre-test and post-test n Copyright © 2007, Kristina Spitler – Almac Clinical Services Results Transfer Learning Reactions

Hear, Understand, Apply n Did they hear you correctly? n Repeat n back Do they understand? n Questions n Can they apply the information? n Demonstrate Copyright © 2007, Kristina Spitler – Almac Clinical Services

Measuring Transfer Level 3: Transfer n Behavior on the job n Error ratios n Rework n Complaints n Observations n Copyright © 2007, Kristina Spitler – Almac Clinical Services Results Transfer Learning Reactions

Ensuring knowledge transfer n “When operating in a robust quality system environment, it is important that supervisory managers ensure that skills gained from training be incorporated into day-to-day performance. ” Pharmaceutical c. GMPs: Integrating FDA’s Risk-Based Approach Copyright © 2007, Kristina Spitler – Almac Clinical Services

Continually Evaluating Training n “…continued training is critical to ensure that the employees remain proficient in their operational functions and in their understanding of c. GMP regulations. ” Pharmaceutical c. GMPs: Integrating FDA’s Risk-Based Approach Copyright © 2007, Kristina Spitler – Almac Clinical Services

Evaluation from start to finish n “Under a quality system, managers are expected to establish training programs that include the following: PEvaluation of training needs PProvision of training to satisfy these needs PEvaluation of effectiveness of training PDocumentation of training and/or re-training. ” Pharmaceutical c. GMPs: Integrating FDA’s Risk-Based Approach Copyright © 2007, Kristina Spitler – Almac Clinical Services