Transcript Contract Lab Needs-Based Training

Contract Lab
Needs-Based Training
Stacy Pritt, DVM, MBA
Associate Director for Animal Care, Training, & Operations
Harvard Medical School
Boston, MA
Outline
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Introduction to Contract Labs
Summary of Needs Based Training
Importance of Assessing Training Needs
Training at CROs
Training Program Examples
What is a Contract Lab?
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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)
From the Client’s 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
CRO’s capabilities and business capacity.
What is Unique
about Contract Labs?
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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.)
What is Unique
about Contract Labs (Continued)?
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Time is of the essence
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Expedited IACUC protocol review
Regulatory & Animal Welfare Audits (by
Regulatory Agencies, Sponsors, others)
Constantly asked to perform novel procedures
High volume business
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Routine Testing
Why is Training Important for CROs
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Regulatory Needs
Accreditation Needs
Certification Needs
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Competitive Advantage
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Training should match the
way in which a company
tries to gain a competitive
advantage
Speed, Innovation,
Quality, Cost
Public Relations
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Animal Welfare
Employees
Customers
Why Needs Based Training?
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Performance Analysis or Training Needs
Analysis
Training and development Initiatives
 Organizational Change
 Succession plan
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Business need for training
History of similar programs
What can a trainer do to ensure success
Assessing Training Needs
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Organizational Level
Task Analysis Level
Individual/Employee
Level
Assessing Training Needs –
Organizational Level
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What are the Goals and
Needs of the Company?
What training will be
useful?
What are the available
resources?
Is the company’s culture
and management
supportive of training?
Assessing Training Needs –
Task Analysis Level
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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?
Assessing Training Needs –
Individual/Employee Level
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Do employees currently posses the skills &
knowledge sets they need?
Who needs training?
What kind of training is needed?
Assessing Training Needs at CROs
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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
Assessing Training Needs for a CRO
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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
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May give you what they would like rather than what they need
Morale booster
Training & CROs
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Regulatory Agencies:
FDA Good Laboratory Practices
 OECD
 ISO - Competence
 MHW
 EPA
 Others
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Training & CROs (Continued)
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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 Need
Animal Related Training
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Animal Care and
Veterinary Staff
Research Staff
(Technicians, Assistants,
Associates, & Study
Directors)
IACUC Members
Sales Staff
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Customer service staff
Histologists
Clients
Temporary Employees
Summer Students
Training Programs
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SOP and Technical Training
Regulatory Needs
Animal Welfare Based
AALAS Certification
Specific Examples
SOP & Technical Training
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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
SOP & Technical Training
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Training programs can be arranged in modules of SOPs
based on the needed skill level
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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
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Core/Routine studies
Infrequently performed studies
Anticipated studies/pilot studies
Training with a Mentor
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Training under a mentor leads to greater
employee job satisfaction
Informal training can often times be more
effective than formal training
Regulatory Needs
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Specific and documented classes/training
modules needed on
GLPs
 ISO procedures
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Refresher training done on
a regular basis, annually
Standardized for the facility
Also…chemical and radiation training, generic
safety training
Animal Welfare Based
Training
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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
AALAS Certification
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Used as adjunct to other aspects of training
program
SOPs, procedures, and study types dictate the
knowledge and skills of technicians at CROs
Example Animal Welfare Training
Program at a CRO
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For all levels of staff—sales, 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
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What are the individual roles?
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Study Director
Sponsor
QA/RA
Study Technician
Animal Care Technician
IACUC
IO
Attending Veterinarian
Clients
Specific Training Examples
(Continued)
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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)
Conclusions
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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 CRO’s business goals
 Enhance an organization’s mission statement
 Demonstrate a superior commitment to animal welfare
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In the end…..
Training makes an organization
more:
Effective
Efficient
Productive
References – Further Information
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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 9001:2000 success
with competency-based training.
www.qualitydigest.com
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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