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21 CFR Part 58: GLP for Nonclinical Laboratories

Rated 5 out of 5
21
21 CFR Part 58 GLP for Nonclinical Laboratories (1)

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

For nonclinical laboratories operating in pharmaceutical, biotech, or biomedical research, compliance with 21 CFR Part 58 is a regulatory baseline. This course provides a thorough introduction to the Good Laboratory Practice (GLP) requirements defined in that regulation, covering personnel roles, facility standards, test article handling, and record keeping obligations.

What you’ll learn?

  • History and significance of GLP in nonclinical laboratories
  • Detailed exploration of 21 CFR Part 58 GLP regulations
  • Understanding the organization and personnel roles in GLP compliance
  • Insights into the facilities, equipment, and operations involved in nonclinical labs
  • Thorough examination of test and control articles and their handling
  • Guidelines for maintaining records, reporting, and dealing with disqualification of testing facilities

Who should enroll?
This course is ideal for professionals involved in nonclinical laboratory studies, including laboratory technicians and quality assurance personnel. It’s also beneficial for those in pharmaceuticals, biotechnology, and medical devices who seek to ensure their operations meet GLP standards.

Upon successful completion, participants will be awarded an internationally recognized GXP training certificate, accredited with CPD/CEU credits

Curriculum

Introduction
Lesson 1: Why is GLP Important in NonClinical Laboratories
Lesson 2: Overview of GLP Regulation (21 CFR Part 58)
Lesson 3: General Provisions and Organization and Personnel
Lesson 4: Facilities
Lesson 5: Equipment and Testing Facilities Operation
Lesson 6: Test and Control Articles
Lesson 7: Protocol for and Conduct of a Nonclinical Laboratory Study
Lesson 8: Records and Reports
Lesson 9: Disqualification and Testing Facilities
Conclusion
Final Assessment

Author:

eliot
Eliot Zate
Eliot Zate has worked in the pharmaceutical industry for more then 25 years ago. He is a recognised expert in the application of Good Laboratory Practice, and has carried out assessments of compliance with the Principles for many organisations worldwide.

Reviews:

Rated 5 out of 5
21
I highly recommend this course to anyone looking to ensure their lab operations are compliant with GLP standards. Plus, the certificate and CPD/CEU credits at the end were a fantastic bonus!
Aleksander AspenEngineer

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

  • Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
  • Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
  • Self-paced : access 24/7 to the course during 12 months at your own rhythm.
  • Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
  • Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
  • Instant Purchase : one click to buy and immediate access. Get certified today.
  • LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
  • HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
  • Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
  • LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.
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$95.00 / year

$95.00 / year

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