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Monday, June 26, 2017
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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
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $195.00

dinaris.org LogoTraining Program: GLP: QC in a Regulated Laboratory
Training Provided By: dinaris.org
Website: http://dinaris.org

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 dinaris.org

Whether your organization needs to run a large-scale training program for new employees or a small scale refresher course, dinaris.org 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.

dinaris.org’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) 111-1111 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, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


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

COURSE OUTLINE:


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

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

GOOD AUTOMATED LABORATORY PRACTICES
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

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

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

MANAGING OOS EVENTS
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

CONCLUSION
42. Summary

COURSE OBJECTIVES:


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.

JOB POSTINGS:

5700 QC QA Quality Lab jobs found.
Displaying jobs #1-4.

Lab Assistant
Posted Date: 2017-06-23
Dignity Health – United States, CA, Bakersfield, 93399

Lab Tech II – Entry Level Chemist
Posted Date: 2017-06-22
Apex Life Sciences – United States, OH, Strongsville, 44136

Quality Assurance Administrator
Posted Date: 2017-06-25
WACO Products Inc. – United States, MD, Baltimore, 21276

Quality Engineer
Posted Date: 2017-06-25
Bartech Group – United States, KY, Bowling Green, 42101

See more QC QA Quality Lab Jobs


For more information on the dinaris.org’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) 111-1111, or email Support@BioPharmaInstitute.com.

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