Contract Lab Needs-Based Training

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Contract Lab Needs-Based Training

• Stacy Pritt, DVM, MBA
• Associate Director for Animal Care, Training,
  Operations
• Harvard Medical School
• Boston, MA

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Outline

• Introduction to Contract Labs
• Summary of Needs Based Training
• Importance of Assessing Training Needs
• Training at CROs
• Training Program Examples

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What is a Contract Lab?

• Private or public company providing pre-clinical
  testing for the product approval of medical
  devices, drugs, and other products meant for
  human and/or animal use
• Strictly adhere to GLPs (CFR 21)
• Expertise in toxicology, biocompatibility, and
  surgical models
• Expertise in Regulatory Affairs
• Also known as Contract Research Organizations
  (CROs)

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From the Clients Perspective

• Using contract research
• services is meant to
• boost productivity and
• capabilities without
• adding permanent
• capabilities1

A CRO is driven by its facilities and
capabilities2 ..training can increase a CROs
capabilities and business capacity.
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What is Unique about Contract Labs?

• Contract labs are not developing their own
  products
• Pharmaceutical, medical device, biotech, and
  other companies are their clients (Sponsors)
• Contact labs strictly adhere to regulatory
  guidelines and client requests
• Contract labs follow a variety of regulatory
  guidelines (FDA, ISO, OECD, EPA, DOD, etc.)

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What is Unique about Contract Labs (Continued)?

• Time is of the essence
• Expedited IACUC protocol review
• Regulatory Animal Welfare Audits (by Regulatory
  Agencies, Sponsors, others)
• Constantly asked to perform novel procedures
• High volume business
• Routine Testing

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Why is Training Important for CROs

• Regulatory Needs
• Accreditation Needs
• Certification Needs

• Competitive Advantage
• Training should match the way in which a company
  tries to gain a competitive advantage
• Speed, Innovation, Quality, Cost
• Public Relations
• Animal Welfare
• Employees
• Customers

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Why Needs Based Training?

• Performance Analysis or Training Needs Analysis
• Training and development Initiatives
• Organizational Change
• Succession plan
• Business need for training
• History of similar programs
• What can a trainer do to ensure success

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Assessing Training Needs

• Organizational Level
• Task Analysis Level
• Individual/Employee Level

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Assessing Training Needs Organizational Level

• What are the Goals and Needs of the Company?
• What training will be useful?
• What are the available resources?
• Is the companys culture and management
  supportive of training?

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Assessing Training Needs Task Analysis Level

• What are the key skills knowledge sets needed?
• With the introduction of new services, what
  skills knowledge sets will be needed?
• Perform an on-the-job analysis
• What training will be relevant
• to the tasks performed?

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Assessing Training Needs Individual/Employee
Level

• Do employees currently posses the skills
  knowledge sets they need?
• Who needs training?
• What kind of training is needed?

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Assessing Training Needs at CROs

• What are the business strategies, new projects,
  and initiatives?
• What are the industry norms/standards?
• What are client and internal expectations?
• What is the baseline for measuring training
  effectiveness?
• Training should have defined benefits and
  expected returns

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Assessing Training Needs for a CRO

• Define the skills and knowledge base that
  employees need for better performance
• Define employee skills and knowledge base that
  will allow the company to reach its goals and
  objectives
• Asking what employees what they want for training
  
• May give you what they would like rather than
  what they need
• Morale booster

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Training CROs

• Regulatory Agencies
• FDA Good Laboratory Practices
• OECD
• ISO - Competence
• MHW
• EPA
• Others

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Training CROs (Continued)

• FDA GLPs
• ISO Competence is defined as the Demonstrated
  ability to apply knowledge and skills.3
• A person can carry out a task in a manner that
  meets the required performance standard
• Competency is achieved through a combination of
  education, training, skills, and experience

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Positions That NeedAnimal Related Training

• Animal Care and Veterinary Staff
• Research Staff (Technicians, Assistants,
  Associates, Study Directors)
• IACUC Members
• Sales Staff

• Customer service staff
• Histologists
• Clients
• Temporary Employees
• Summer Students

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Training Programs

• SOP and Technical Training
• Regulatory Needs
• Animal Welfare Based
• AALAS Certification
• Specific Examples

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SOP Technical Training

• Most common form of training at CROs
• Due to the heavily regulated nature of the
  industry, SOPs are scrutinized by clients,
  regulatory agencies, and others
• Training is usually SOP based and technical
  procedures are interwoven
• SOPs will outline the training needed for each
  job description as well as procedure

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SOP Technical Training

• Training programs can be arranged in modules of
  SOPs based on the needed skill level
• Mock studies
• One-on-one observation by a qualified person
  (mentoring)
• Sequencing of tasks
• When problems arise, SOPs are reviewed and/or
  revised as necessary
• Technical training is heavily dependent on what
  type of studies are being performed
• Core/Routine studies
• Infrequently performed studies
• Anticipated studies/pilot studies

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Training with a Mentor

• Training under a mentor leads to greater employee
  job satisfaction
• Informal training can often times be more
  effective than formal training

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Regulatory Needs

• Specific and documented classes/training modules
  needed on
• GLPs
• ISO procedures
• Refresher training done on
• a regular basis, annually
• Standardized for the facility
• Alsochemical and radiation training, generic
  safety training

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Animal Welfare Based Training

• Important to remember that the FDA assumes, but
  does not focus on animal well-being2
• USDA has no focus on study design, integrity, and
  data collection2
• Animal Welfare audits of CROs by sponsors
  (Pharma)
• Need for animal welfare training to educate staff
  and meet (or exceed) Sponsor expectations

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AALAS Certification

• Used as adjunct to other aspects of training
  program
• SOPs, procedures, and study types dictate the
  knowledge and skills of technicians at CROs

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Example Animal Welfare Training Program at a CRO

• For all levels of staffsales, QA, RA, new Study
  Directors, histologists, clients, etc.
• Differences between animal rights and animal
  welfare
• What are the regulations followed?
• Why and how the facility maintains compliance
• IACUC GLP Protocols
• Pain suffering
• How and why animals are used
• Why training is needed

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Specific Training Examples

• What are the individual roles?
• Study Director
• Sponsor
• QA/RA
• Study Technician
• Animal Care Technician
• IACUC
• IO
• Attending Veterinarian
• Clients

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Specific Training Examples (Continued)

• How animal research and/or product testing
  benefits both animals and humans.
• What particular types of research performed at
  the CRO are especially useful/beneficial (past
  examples?).
• Who handles concerns regarding animal welfare?
• Tour (non-scientific staff with appropriate oc
  health precautions)

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Conclusions

• CROs are heavily regulated
• Clients as well as regulatory and animal welfare
  guidelines demand a strong training program for
  CRO staff
• Assessing training needs and having an
  excellently structured training program can
• Further a CROs business goals
• Enhance an organizations mission statement
• Demonstrate a superior commitment to animal
  welfare

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In the end..

• Training makes an organization more
• Effective
• Efficient
• Productive

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References Further Information

• Citations
• 1. FDA Inspections.com (2004). Using Contract
  Services Wisely. www.fdainspection.com
• 2. Ballinger, M. (2004). External Oversight
  A View From Industry. ARENA IACUC Conference.
• 3. Cochran, C. (2000). Sow the seeds of ISO
  90012000 success with competency-based training.
  www.qualitydigest.com

• Further Information
• Pritt, S., Samalonis, P., Bindley, L., and
  Schade, A. (2004). Creating a Comprehensive
  Training Documentation Program. Lab Animal,
  33(4).
• Kennedy, B.W. (2002). Creating a Training
  Coordinator Position. Lab Animal, 31(6).

www.LAWTE.org