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Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Preclinical & Laboratory Foundations Learning Path
4.2
★★★★★
91% Recommended
Updated 2025
20 hours
142 active users
20 points
If you'd like to swap a course or add additional courses, simply let us know — Reach out to us and we’ll customize a learning path tailored to your training needs.
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Each course includes:
Fully compliant
This learning path is aligned with FDA 21 CFR Part 58 (GLP), ISO/IEC 17025:2017, OSHA laboratory safety standards, GAMP 5, and ICH guidelines, equipping learners with the regulatory and quality foundations required for preclinical and laboratory environments. Learners receive Continuing Professional Development (CPD) Points awarded by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom.
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam does not mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training.
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About
The Preclinical & Laboratory Foundations Learning Path is designed to equip professionals with the essential regulatory, quality, and safety knowledge required to operate effectively in preclinical research and laboratory environments. Covering Good Laboratory Practice (GLP) under both ICH principles and FDA 21 CFR Part 58, laboratory safety, ISO/IEC 17025 accreditation, computer system validation, equipment qualification, cleaning validation, and GMP foundations, this programme provides a structured pathway from laboratory basics through to compliance readiness.
Participants will develop a thorough understanding of nonclinical study conduct, laboratory quality systems, data integrity requirements, and the validation frameworks essential for regulated laboratory environments. The programme ensures learners are prepared to support preclinical activities that feed directly into clinical development programmes, regulatory submissions, and product approval processes.
How this differs from the Phase I First-in-Human Learning Path
The Preclinical & Laboratory Foundations Learning Path focuses on the nonclinical and laboratory quality environment — covering GLP, laboratory management systems, instrument qualification, cleaning validation, and foundational GMP. It is designed for laboratory scientists, quality assurance personnel, and validation specialists operating upstream of clinical trials.
In comparison, the Phase I First-in-Human Learning Path focuses on the regulatory, ethical, and operational requirements for conducting first-in-human clinical trials — including GCP, informed consent, dose escalation design, and site-level trial management. This learning path is the essential precursor for professionals who want to understand the scientific and quality infrastructure that supports the transition from discovery to clinical development.
Who Should Enrol?
- Laboratory scientists, research associates, and CRO professionals working in pharmaceutical and preclinical research environments.
- Quality assurance, quality control, and validation professionals in laboratory and nonclinical settings.
- Regulatory affairs professionals seeking knowledge of nonclinical laboratory compliance and GLP requirements.
- Laboratory managers, validation specialists, and life sciences graduates entering regulated laboratory or pharmaceutical research roles.
What you will learn
Understand the fundamentals of preclinical and laboratory research, including GLP principles and FDA nonclinical laboratory requirements.
Learn how to implement and maintain laboratory quality systems aligned with ISO/IEC 17025 standards in regulated environments.
Develop knowledge of equipment qualification, cleaning validation, and laboratory validation practices essential for compliant operations.
Gain practical understanding of GAMP 5 CSV methodology and GMP frameworks to support high-quality preclinical research and drug development processes.
Courses Included
Principles and application of GLP in nonclinical laboratory studies — study plans, raw data, archives, and quality assurance
6 hours
6 points
FDA GLP requirements for nonclinical safety studies — facilities, personnel, equipment, and study conduct under 21 CFR Part 58
3 hours2 pointsChemical hygiene, hazard communication, PPE, and emergency procedures for laboratory personnel under OSHA standards
3 hours2 points
Accreditation requirements for testing and calibration laboratories — competence, impartiality, and consistent operation under ISO/IEC 17025
2 hours3 pointsGAMP 5 risk-based CSV methodology and data integrity principles for laboratory computerised systems
3 hours2 points
IQ, OQ, PQ qualification stages for laboratory equipment and analytical instruments in regulated environments
1 hours2 pointsCleaning validation principles, acceptance criteria, swab and rinse sampling, and regulatory expectations for pharmaceutical laboratory equipment
2 hours3 pointsQuality management system foundations under ISO 9001:2015 applied to pharmaceutical organisations and laboratory environments
3 hours2 pointsOur Certified Customers
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Frequently Asked Questions
- Laboratory scientists and research associates in pharmaceutical and CRO environments
- Quality assurance and quality control professionals in preclinical settings
- Validation specialists and laboratory systems engineers
- Regulatory affairs professionals seeking nonclinical regulatory knowledge
- Laboratory managers responsible for GLP compliance and accreditation
- Professionals transitioning from academic research into regulated industry laboratory roles
- Life sciences graduates entering pharmaceutical or contract laboratory organisations
Upon completion of this learning path, participants will be able to apply GLP principles and FDA nonclinical laboratory requirements, maintain laboratory quality systems in line with ISO/IEC 17025, conduct equipment qualification and cleaning validation, apply GAMP 5 CSV methodology to laboratory systems, and operate within GMP-compliant frameworks — equipping them to support compliant preclinical research and laboratory operations that underpin clinical development programmes.
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