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Tuesday, January 22, 2019
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GLP 0: Good Laboratory Practice, Overview (GLPRA)

Certification Training Duration: 1.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GLP 0: Good Laboratory Practice, Overview
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. This course will introduce you to the concepts and requirements necessary for compliance with Good Laboratory Practice (GLP). This course will help prepare you to establish and document a system of GLP controls required to test medical products where data is intended for inclusion into a regulatory filing in the United States, the European Union, Japan, and in many parts of the world.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The GLP 0: Good Laboratory Practice, Overview course is found in the following professional certification program(s):


COURSE OUTLINE:


INTRODUCTION
1. Course Information
2. Interface Tour
3. Course Overview

PURPOSE AND ELEMENTS OF GLP
4. Objectives
5. Pre-Test
6. Origins of the GLP Regulations
7. Protocols and Reports
8. Quality Assurance Program
9. Inspections of GLP Labs
10. Progress Check

GLP RESPONSIBILITIES
11. Objectives
12. Pre-Test
13. Responsibilities of Management and Personnel
14. Responsibilities of the Study Director
15. Responsibilities of Quality Assurance
16. Progress Check

AREAS OF GLP
17. Objectives
18. Pre-Test
19. Facilities and Instrumentation
20. Reagents and Solutions
21. Animal Care
22. Test and Control Materials
23. Progress Check

DOCUMENTATION
24. Objectives
25. Pre-Test
26. Standard Operating Procedures
27. Document Change Control
28. Data Recording Rules
29. Records/Archive Management
30. Progress Check

CONCLUSION
31. Summary

COURSE OBJECTIVES:


List the purpose of Good Laboratory Practice (GLP) regulations.
Describe two events that inform the institution of the GLP regulations.
Describe four elements of GLP.
Discuss the three areas that will be reviewed during a GLP inspection.
List the responsibilities of Management.
Understand Personnel responsibilities.
Describe the responsibilities of the Study Director.
Discuss the responsibilities of Quality Assurance.
Understand the GLP area of Facilities and Instrumentation.
Describe Standard Operating Procedures.
Discuss the GLP area of Reagents and Solutions.
Understand the GLP area of Animal Care.
Describe the GLP area of Test and Control Materials.
Describe the purpose of SOPs and document change control.
List the records required under GLP.
List the data recording rules intended to demonstrate the integrity of nonclinical study data.
Describe the retention period for GLP study data.


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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