Contract Lab Contract Lab Needs-Based Needs-Based

TrainingTrainingStacy Pritt, DVM, MBAStacy Pritt, DVM, MBA

Associate Director for Animal Care, Training, & Associate Director for Animal Care, Training, & OperationsOperations

Harvard Medical SchoolHarvard Medical SchoolBoston, MABoston, MA

OutlineOutline

Introduction to Contract LabsIntroduction to Contract Labs Summary of Needs Based TrainingSummary of Needs Based Training Importance of Assessing Training Importance of Assessing Training

NeedsNeeds Training at CROsTraining at CROs Training Program ExamplesTraining Program Examples

What is a Contract Lab?What is a Contract Lab?

Private or public company providing Private or public company providing pre-clinical testing for the product pre-clinical testing for the product approval of medical devices, drugs, approval of medical devices, drugs, and other products meant for human and other products meant for human and/or animal useand/or animal use

Strictly adhere to GLPs (CFR 21)Strictly adhere to GLPs (CFR 21) Expertise in toxicology, Expertise in toxicology,

biocompatibility, and surgical modelsbiocompatibility, and surgical models Expertise in Regulatory AffairsExpertise in Regulatory Affairs Also known as Contract Research Also known as Contract Research

Organizations (CROs)Organizations (CROs)

From the Client’s From the Client’s Perspective…Perspective…

Using contract Using contract researchresearch

services is meant toservices is meant to

boost productivity boost productivity and and

capabilities without capabilities without

adding permanent adding permanent

capabilitiescapabilities11A CRO is driven by its facilities and capabilitiesA CRO is driven by its facilities and capabilities22

……..training can increase a..training can increase aCRO’s capabilities and business capacity.CRO’s capabilities and business capacity.

What is Unique What is Unique about Contract Labs?about Contract Labs?

Contract labs are not developing their Contract labs are not developing their own productsown products

Pharmaceutical, medical device, biotech, Pharmaceutical, medical device, biotech, and other companies are their clients and other companies are their clients (Sponsors)(Sponsors)

Contact labs strictly adhere to regulatory Contact labs strictly adhere to regulatory guidelines and client requestsguidelines and client requests

Contract labs follow a variety of Contract labs follow a variety of regulatory guidelines (FDA, ISO, OECD, regulatory guidelines (FDA, ISO, OECD, EPA, DOD, etc.)EPA, DOD, etc.)

What is Unique What is Unique about Contract Labs about Contract Labs

(Continued)?(Continued)? Time is of the essenceTime is of the essence

Expedited IACUC protocol reviewExpedited IACUC protocol review Regulatory & Animal Welfare Audits Regulatory & Animal Welfare Audits

(by Regulatory Agencies, Sponsors, (by Regulatory Agencies, Sponsors, others)others)

Constantly asked to perform novel Constantly asked to perform novel proceduresprocedures

High volume businessHigh volume business Routine TestingRoutine Testing

Why is Training Important Why is Training Important for CROsfor CROs

Regulatory NeedsRegulatory Needs Accreditation Accreditation

NeedsNeeds Certification NeedsCertification Needs

Competitive Competitive AdvantageAdvantage Training should match Training should match

the way in which a the way in which a company tries to gain company tries to gain a competitive a competitive advantageadvantage

Speed, Innovation, Speed, Innovation, Quality, CostQuality, Cost

Public RelationsPublic Relations Animal WelfareAnimal Welfare EmployeesEmployees CustomersCustomers

Why Needs Based Why Needs Based Training?Training?

Performance Analysis or Training Performance Analysis or Training Needs AnalysisNeeds Analysis Training and development InitiativesTraining and development Initiatives Organizational ChangeOrganizational Change Succession planSuccession plan

Business need for trainingBusiness need for training History of similar programsHistory of similar programs What can a trainer do to ensure What can a trainer do to ensure

successsuccess

Assessing Training Assessing Training NeedsNeeds

Organizational Organizational LevelLevel

Task Analysis Task Analysis LevelLevel

Individual/Individual/Employee LevelEmployee Level

Assessing Training Needs – Assessing Training Needs – Organizational LevelOrganizational Level

What are the Goals What are the Goals and Needs of the and Needs of the Company?Company?

What training will be What training will be useful?useful?

What are the available What are the available resources?resources?

Is the company’s Is the company’s culture and culture and management management supportive of training?supportive of training?

Assessing Training Needs – Assessing Training Needs – Task Analysis LevelTask Analysis Level

What are the key skills & knowledge What are the key skills & knowledge sets needed?sets needed?

With the introduction of new With the introduction of new services, what skills & knowledge services, what skills & knowledge sets will be needed?sets will be needed?

Perform an on-the-job analysisPerform an on-the-job analysis What training will be relevant What training will be relevant

to the tasks performed?to the tasks performed?

Assessing Training Needs – Assessing Training Needs – Individual/Employee LevelIndividual/Employee Level

Do employees currently posses the Do employees currently posses the skills & knowledge sets they need?skills & knowledge sets they need?

Who needs training?Who needs training? What kind of training is needed?What kind of training is needed?

Assessing Training Needs Assessing Training Needs at CROsat CROs

What are the business strategies, new What are the business strategies, new projects, and initiatives?projects, and initiatives?

What are the industry norms/standards?What are the industry norms/standards? What are client and internal What are client and internal

expectations?expectations? What is the baseline for measuring What is the baseline for measuring

training effectiveness?training effectiveness? Training should have defined benefits Training should have defined benefits

and expected returnsand expected returns

Assessing Training Needs Assessing Training Needs for a CROfor a CRO

Define the skills and knowledge base that Define the skills and knowledge base that employees need for better performanceemployees need for better performance

Define employee skills and knowledge Define employee skills and knowledge base that will allow the company to reach base that will allow the company to reach its goals and objectivesits goals and objectives

Asking what employees what they want Asking what employees what they want for training for training May give you what they would like rather than May give you what they would like rather than

what they needwhat they need Morale boosterMorale booster

Training & CROsTraining & CROs

Regulatory Agencies:Regulatory Agencies: FDA Good Laboratory PracticesFDA Good Laboratory Practices OECDOECD ISO - CompetenceISO - Competence MHWMHW EPAEPA OthersOthers

Training & CROs Training & CROs (Continued)(Continued)

FDA GLPsFDA GLPs ISO – Competence is defined as the ISO – Competence is defined as the

“Demonstrated ability to apply “Demonstrated ability to apply knowledge and skills.knowledge and skills.3”3”

A person can carry out a task in a A person can carry out a task in a manner that meets the required manner that meets the required performance standardperformance standard

Competency is achieved through a Competency is achieved through a combination of education, training, skills, combination of education, training, skills, and experienceand experience

Positions That NeedPositions That NeedAnimal Related TrainingAnimal Related Training

Animal Care and Animal Care and Veterinary StaffVeterinary Staff

Research Staff Research Staff (Technicians, (Technicians, Assistants, Assistants, Associates, & Associates, & Study Directors)Study Directors)

IACUC MembersIACUC Members Sales StaffSales Staff

Customer service Customer service staffstaff

HistologistsHistologists ClientsClients Temporary Temporary

EmployeesEmployees Summer StudentsSummer Students

Training ProgramsTraining Programs

SOP and Technical TrainingSOP and Technical Training Regulatory Needs Regulatory Needs Animal Welfare BasedAnimal Welfare Based AALAS Certification AALAS Certification Specific ExamplesSpecific Examples

SOP & Technical SOP & Technical TrainingTraining

Most common form of training at CROsMost common form of training at CROs Due to the heavily regulated nature of Due to the heavily regulated nature of

the industry, SOPs are scrutinized by the industry, SOPs are scrutinized by clients, regulatory agencies, and othersclients, regulatory agencies, and others

Training is usually SOP based and Training is usually SOP based and technical procedures are interwoventechnical procedures are interwoven

SOPs will outline the training needed SOPs will outline the training needed for each job description as well as for each job description as well as procedureprocedure

SOP & Technical SOP & Technical TrainingTraining

Training programs can be arranged in Training programs can be arranged in modules of SOPs based on the needed skill modules of SOPs based on the needed skill levellevel Mock studiesMock studies One-on-one observation by a qualified person One-on-one observation by a qualified person

(mentoring)(mentoring) Sequencing of tasks Sequencing of tasks

When problems arise, SOPs are reviewed When problems arise, SOPs are reviewed and/or revised as necessaryand/or revised as necessary

Technical training is heavily dependent on Technical training is heavily dependent on what type of studies are being performedwhat type of studies are being performed Core/Routine studiesCore/Routine studies Infrequently performed studies Infrequently performed studies Anticipated studies/pilot studiesAnticipated studies/pilot studies

Training with a MentorTraining with a Mentor

Training under a mentor leads to Training under a mentor leads to greater employee job satisfactiongreater employee job satisfaction

Informal training can often times be Informal training can often times be more effective than formal trainingmore effective than formal training

Regulatory NeedsRegulatory Needs

Specific and documented Specific and documented classes/training modules needed on classes/training modules needed on GLPsGLPs ISO proceduresISO procedures

Refresher training done onRefresher training done ona regular basis, annuallya regular basis, annually

Standardized for the facilityStandardized for the facility Also…chemical and radiation Also…chemical and radiation

training, generic safety trainingtraining, generic safety training

Animal Welfare BasedAnimal Welfare Based Training Training

Important to remember that the FDA Important to remember that the FDA assumes, but does not focus on animal assumes, but does not focus on animal well-beingwell-being22

USDA has no focus on study design, USDA has no focus on study design, integrity, and data collectionintegrity, and data collection22

Animal Welfare audits of CROs by Animal Welfare audits of CROs by sponsors (Pharma)sponsors (Pharma)

Need for animal welfare training to Need for animal welfare training to educate staff and meet (or exceed) educate staff and meet (or exceed) Sponsor expectationsSponsor expectations

AALAS CertificationAALAS Certification

Used as adjunct to other aspects of Used as adjunct to other aspects of training programtraining program

SOPs, procedures, and study types SOPs, procedures, and study types dictate the knowledge and skills of dictate the knowledge and skills of technicians at CROstechnicians at CROs

Example Animal Welfare Example Animal Welfare Training Program at a CROTraining Program at a CRO

For all levels of staff—sales, QA, RA, For all levels of staff—sales, QA, RA, new Study Directors, histologists, new Study Directors, histologists, clients, etc.clients, etc.

Differences between animal rights and Differences between animal rights and animal welfareanimal welfare

What are the regulations followed?What are the regulations followed? Why and how the facility maintains Why and how the facility maintains

compliancecompliance IACUC & GLP ProtocolsIACUC & GLP Protocols Pain & sufferingPain & suffering How and why animals are usedHow and why animals are used Why training is neededWhy training is needed

Specific Training Specific Training ExamplesExamples

What are the individual roles?What are the individual roles? Study DirectorStudy Director SponsorSponsor QA/RAQA/RA Study TechnicianStudy Technician Animal Care TechnicianAnimal Care Technician IACUCIACUC IOIO Attending VeterinarianAttending Veterinarian ClientsClients

Specific Training Examples Specific Training Examples (Continued)(Continued)

How animal research and/or product How animal research and/or product testing benefits both animals and humans.testing benefits both animals and humans.

What particular types of research What particular types of research performed at the CRO are especially performed at the CRO are especially useful/beneficial (past examples?).useful/beneficial (past examples?).

Who handles concerns regarding animal Who handles concerns regarding animal welfare?welfare?

Tour (non-scientific staff with appropriate Tour (non-scientific staff with appropriate oc health precautions)oc health precautions)

ConclusionsConclusions

CROs are heavily regulatedCROs are heavily regulated Clients as well as regulatory and animal Clients as well as regulatory and animal

welfare guidelines demand a strong welfare guidelines demand a strong training program for CRO stafftraining program for CRO staff

Assessing training needs and having an Assessing training needs and having an excellently structured training program excellently structured training program can:can: Further a CRO’s business goalsFurther a CRO’s business goals Enhance an organization’s mission statementEnhance an organization’s mission statement Demonstrate a superior commitment to Demonstrate a superior commitment to

animal welfareanimal welfare

In the end…..In the end…..

Training makes an Training makes an organization more:organization more:

EffectiveEffective

EfficientEfficient

ProductiveProductive

References – Further References – Further InformationInformationCitationsCitations

1. FDA Inspections.com 1. FDA Inspections.com (2004). Using Contract (2004). Using Contract Services Wisely. Services Wisely. www.fdainspection.comwww.fdainspection.com

2. Ballinger, M. (2004). 2. Ballinger, M. (2004). External Oversight: A External Oversight: A View From Industry. View From Industry. ARENA IACUC ARENA IACUC Conference.Conference.

3. Cochran, C. (2000). 3. Cochran, C. (2000). Sow the seeds of ISO Sow the seeds of ISO 9001:2000 success with 9001:2000 success with competency-based competency-based training. training. www.qualitydigest.comwww.qualitydigest.com

Further InformationFurther Information Pritt, S., Samalonis, P., Pritt, S., Samalonis, P.,

Bindley, L., and Schade, A. Bindley, L., and Schade, A. (2004). Creating a (2004). Creating a Comprehensive Training Comprehensive Training Documentation Program. Documentation Program. Lab Lab Animal, 33Animal, 33(4).(4).

Kennedy, B.W. (2002). Kennedy, B.W. (2002). Creating a Training Creating a Training Coordinator Position. Coordinator Position. Lab Lab Animal, 31Animal, 31(6).(6).

www.LAWTE.org