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 • 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? • 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? • 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)? • 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

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 Why is Training Important for CROs

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

Assessing Training Needs • Organizational Level • Task Analysis Level • Individual/Employee Level

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 company’s culture and management supportive of training?

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?

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?

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

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

Training & CROs • Regulatory Agencies: • FDA Good Laboratory Practices • OECD • ISO - Competence • MHW • EPA • Others

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

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 Positions That NeedAnimal Related Training

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

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

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

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

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 • Also…chemical and radiation training, generic safety training

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

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

Example Animal Welfare Training Program at a CRO • 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

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

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)

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 CRO’s business goals • Enhance an organization’s mission statement • Demonstrate a superior commitment to animal welfare

In the end….. Training makes an organization more: Effective Efficient Productive

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 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). References – Further Information www.LAWTE.org

Contract Lab Needs-Based Training