New
SM
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...
21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
97% Recommended
3 hours
0 active users
2 points
Watch Preview
Your Study Basket
21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories
| Total |
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories is a comprehensive program designed to provide professionals with a practical understanding of FDA Good Laboratory Practice requirements for nonclinical laboratory studies. The course focuses on ensuring the quality, integrity, reliability, and traceability of nonclinical safety data used to support regulatory submissions for pharmaceuticals, biologics, medical devices, and related products.
This 21 CFR Part 58 — Good Laboratory Practice (GLP) for Nonclinical Laboratories Course & Certification provides structured training on GLP regulations, study conduct, personnel responsibilities, facility and equipment controls, protocol management, data integrity, quality assurance, record retention, inspections, and compliance management. Upon completion, learners receive certification demonstrating competency in GLP principles and regulatory expectations for nonclinical laboratory operations.
Who Should Enrol?
- Nonclinical Research, Toxicology, and Laboratory Professionals involved in regulated studies.
- Quality Assurance, Quality Management, and Compliance Personnel supporting GLP operations.
- Study Directors, Principal Investigators, Laboratory Managers, and Research Scientists.
- Regulatory Affairs and Preclinical Development Professionals working with nonclinical data submissions.
- Entry-level professionals and consultants seeking certification in GLP compliance and nonclinical laboratory operations.
What you will learn
Understand the requirements of 21 CFR Part 58, GLP principles, regulatory expectations, and the structure of nonclinical laboratory quality systems.
Learn the roles and responsibilities of study directors, management, quality assurance units, and laboratory personnel involved in GLP studies.
Develop expertise in protocol development, study conduct, test and control article management, data integrity, raw data handling, and documentation practices.
Gain knowledge of inspections, quality assurance activities, record retention, archiving, deviation management, non-compliance investigations, and lessons learned from GLP case studies.
Course Syllabus
- What is Good Laboratory Practice?
- The history that built Part 58
- The shape of 21 CFR Part 58
- GLP vs GMP vs GCP
- OECD GLP Principles
- GLP studies in the product lifecycle
- Inspection and consequences
- Subpart A — General Provisions
- Subpart B — Organization and Personnel
- Subpart C — Facilities
- Subpart D — Equipment
- Subpart E — Testing Facility Operation
- Subparts F, G, J — Articles, Conduct, Records
- Subpart K — Disqualification
- Testing Facility Management
- The Study Director
- The Quality Assurance Unit
- Personnel — qualifications and training
- Sponsor & CRO relationships
- Common Form 483 patterns — Personnel
- Subpart C — Facilities
- Subpart D — Equipment
- Computerised systems
- Environmental controls
- Common 483 patterns — Facilities & Equipment
- SOPs — the operational backbone
- Reagents and solutions
- Animal care during the study
- Specimen handling
- Operational rhythm
- Common 483 patterns — Operations
- What test and control articles are
- §58.105 — Characterisation
- §58.107 — Handling
- §58.113 — Carrier mixtures
- Chain of custody
- Common 483 patterns — Test articles
- §58.120 — The protocol
- Protocol amendments
- Protocol deviations
- §58.130 — Conduct of the study
- Practical conduct
- Common 483 patterns — Conduct
- What data integrity means
- ALCOA in depth
- ALCOA+ extensions
- Data manipulation patterns
- Audit trails
- Preventive controls
- Real warning-letter themes
- The final report
- The archive
- Retention periods
- Archive transfers
- Common 483 patterns — Records & Archives
- The QAU programme
- FDA inspection types
- During the inspection
- Responding to a Form 483
- Inspection-readiness
- Common inspection patterns
- The spectrum of non-compliance
- Subpart K — Disqualification
- Refusal to rely
- Sponsor consequences
- Real disqualification cases
- Staying off the path
- The IBT case revisited
- The Searle/Bressler Report revisited
- Modern data integrity warning letters
- Disqualification cases
- Sponsor exposure
- Synthesis
Course Benefits
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to 21 CFR Part 58, FDA BIMO inspection guidance, and OECD GLP principles, as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by experienced study directors and QA leads to ensure that learners can apply 21 CFR Part 58 in nonclinical laboratory practice.
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
Best Seller
