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Wednesday, May 24, 2017
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GLP Quality Control: IQ/OQ and Calibration of Lab Equipment (GLPQ02)

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

BioPharma Institute LogoTraining Program: GLP Quality Control: IQ/OQ and Calibration of Lab Equipment
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 can be taken online and covers the requirements for the qualification of laboratory instruments including PQ, OQ, and IQ. An explanation of the relationship between qualification, user requirement specifications, and vendors is given. Also addressed is a different approach to complex and simple instruments. Collaboration requirements and specifications for chromatographic systems, spectrophotometers, and dissolution apparatus are reviewed. Once all course requirements have been satisfied you will have access to a Certificate of Completion in PDF format.

Benefits of Getting Certified at BioPharma Institute

By employing new automated tracking systems coupled with advanced e-learning training techniques, the BioPharma Institute is helping companies maintain training records, educate their employees, and improve their quality of service overall. In addition to providing online training, we’ve also been assisting other healthcare and biotech businesses develop over the years. We have worked with businesses such as GE Healthcare, 3M, Siemens, Wyeth, and more.

We have both the course content and the experience needed to deliver the highest quality training to you, your colleagues, and/or your employees. These are things you need to succeed in achieving professional objectives and advance careers. At BioPharma Institute we have the programs necessary to help you achieve those goals.

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 support@biopharmainstitute.com 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 Quality Control: IQ/OQ and Calibration of Lab Equipment Course is Found in the Following Professional Certification Program(s):


Quality Control in the Laboratory Professional Certification Program: The Quality Control in the Laboratory Professional Certification Program is an online program offered by BioPharma Institute. The program offers to provide quality information regarding current standards govern … Learn more

COURSE OUTLINE:


QC REGULATIONS AND QUALIFICATION
1. Introduction
2. Instrument calibration
3. Useful definitions
4. Good QC laboratory data
5. The V model
6. Applying the V model
7. Simple vs complex instruments
8. Qualification phases
9. Vendors
10. Lab instrument specialist
11. Review

INSTRUMENT QUALIFICATION
12. Introduction
13. Instrument URS
14. Qualification approach
15. Steps of IQ
16. IQ: USP definition
17. OQ Phase
18. OQ: USP definition
19. HPLC OQ
20. PQ Phase
21. HPLC PQ
22. PQ: USP definition
23. System suitability testing
24. SST acceptance criteria
25. Qualification protocols
26. Protocol execution
27. Summary
28. Review

CALIBRATION RECORDS
29. Introduction
30. Calibration and performance checks
31. Precision and accuracy
32. GLP identification rules
33. Scope of calibration
34. Calibration rules
35. Schedules
36. Calibration records
37. Review

LABORATORY SOFTWARE QUALIFICATION
38. Introduction
39. Classes of software
40. Software qualification rules
41. Software examples
42. Qualifying spreadsheets
43. Review I
44. Review II

CHROMATOGRAPHIC SYSTEMS
45. Introduction
46. HPLC/GC
47. HPLC components
48. Typical specifications
49. Column maintenance
50. Mobile phase
51. SST

SPECTROPHOTOMETRIC SYSTEMS
52. Introduction
53. Types of systems
54. Operation principles
55. Typical specifications
56. Cell specifications
57. Calibration tasks I
58. Calibration tasks II

DISSOLUTION APPARATUS
59. Introduction
60. Dissolution apparatus
61. Performance parameters
62. Typical specifications
63. Calibration tasks
64. Review

INSTRUMENT LOGBOOKS AND EQUIPMENT HISTORY
65. Introduction
66. Purpose
67. What to record
68. Review

CONCLUSION
69. Summary

COURSE OBJECTIVES:


Describe the steps involved in IQ and OQ of instruments.
State the requirements for software qualification.
List chromatography instrument calibration requirements and frequency.
List general lab instrument calibration requirements and frequency.
State the QC expectations for instrument logbooks.


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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