Student Login |

Sunday, December 16, 2018
Home » Online Training Course

GLP: QC in a Regulated Laboratory (GLP02)

Certification Training Duration: 2 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.
Catalog: Good Laboratory Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

BioPharma Institute LogoTraining Program: GLP: QC in a Regulated Laboratory
Training Provided By: BioPharma Institute

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online course introduces students to the basic requirements and concepts of quality control in a regulated pharmaceutical laboratory. It discusses issues that laboratory auditors focus on. Also presented will be particular pharmaceutical regulatory requirements, including, but not limited to, current good automated laboratory practices, the handling of specific conditions, and requirements for investigation of specific conditions. There will be a review of the current guidelines published by the FDA and the TGA. Once all course requirements have been satisfied, students will have immediate access to a certificate of completion in PDF format.

Benefits of Getting Certified at BioPharma Institute

Whether your organization needs to run a large-scale training program for new employees or a small scale refresher course, BioPharma Institute has the resources and industry knowledge to deliver top-of-the-line training for you, your employees, and your colleagues. Our state-of-the-art e-learning system makes online learning seem easy while providing various educational implements to help students learn the essentials.

BioPharma Institute’s certifications are recognized in many well-known industries, and our training program solutions can be customized to fit the needs of most organizations. For over two decades, we have aided thousands of businesses in the training of their employees. We are at the top of our game when it comes to online training for professionals working in the pharmaceutical, biotechnology, and healthcare industry.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

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: QC in a Regulated Laboratory course is found in the following professional certification program(s):

Good Laboratory Practice (GLP) Professional Certification Program: The Good Laboratory Practice (GLP) Professional Certification Program comprises a set of seven courses designed to provide a comprehensive overview of good lab practice concepts and requirements in compliance w … Learn more


1. Introduction
2. Terminology
3. Compliance rules
4. Pharmacopoeias
5. cGMP references
6. Interpreting the rules
7. Review

8. Introduction
9. Specification
10. Reference standards
11. Preparing and standardizing
12. GLP labeling

13. Introduction
14. Raw vs Derived data
15. CFR Part 11 requirements
16. Recording raw data
17. HPLC
18. Raw data storage
19. Storing electronic data
20. Review

21. Introduction
22. Notebooks and worksheets
23. Completing records
24. Checking calculations
25. Archiving rules for records
26. Supporting records
27. Review

28. Introduction
29. Sample lifecycle
30. Altering records
31. Example
32. Significant figures
33. Review

34. Introduction
35. Out-of-specification
36. OOS origin
37. GLP rules regarding OOS
38. OOS handling
39. Resolving OOS events
40. Handling OOT events
41. Review

42. Summary


List, locate and interpret several G(QC)LP compliance standards.
Describe how to manage reference standards and standard reagents.
State key compliance rules for managing automated information.
Describe the GLP ‘rules’ for completing laboratory notebooks.
Describe the GLP ‘rules’ for reporting and altering laboratory data.
List the essential requirements for evaluating laboratory OOS conditions.

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

Information Request / Suggest a Course Form:

Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):