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Saturday, June 24, 2017
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Validation: Principles/International Regulations (VAL01)

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: Validation: Principles/International Regulations
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online training program offers an introduction to the principles behind and the international regulations to assure effective qualification and validation. The entire program must be viewed by students. In order to pass the course, students must achieve a passing grade of 80% or more on the online, multiple choice final assessment.

Course objectives include the following: To provide a description of the V-model approach to validation, to list the scope of validation, to description of the roles of a validation team and the difference between noncritical and critical equipment – in terms of validation activities, to detail the reasons for validation, to describe the development of regulatory control and validation, and to define some important validation terms.

Once all course requirements have been satisfied, a certificate of completion is immediately available in PDF format. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. No matter how big or small, the dinaris.org can handle the refreshment course or training needs of your company. Let us share our experience, high-quality course content, and proven techniques with you and your employees to further the understanding of the requirements pertaining to the pharmaceutical, biotechnology, and healthcare industries.

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 Validation: Principles/International Regulations Course is Found in the Following Professional Certification Program(s):


Pharmaceutical Validation Management Professional Certification Program: This online professional certification program includes an introduction to the principles behind the international regulations of effective validation and qualification. Additionally, it introduces the internat … Learn more

Computer System Validation Professional Certification Program: This online professional certification program includes an introduction to the international principles and regulations behind effective validation and qualification, an introduction to the international princi … Learn more

COURSE OUTLINE:


INTRODUCTION
1. Outcomes
2. First Class Pharmaceuticals
3. Introductions
4. New liquids line
5. Definition of validation
6. Equipment qualification
7. Process validation
8. Process control
9. Glossary of terms
10. NA regulations
11. PICS/EU/TGA regulations
12. Summary
13. Review

OVERVIEW
14. Introduction
15. History of validation
16. Origins
17. Current trends
18. Applying risk assessment
19. Assessing risk
20. Summary
21. Review

WHAT TO VALIDATE?
22. Introduction
23. Developing the scope
24. Other consideration
25. Critical vs non-critical
26. Services and utilities
27. Computerized systems
28. Selecting process steps
29. Cleaning validation
30. Cleaning validation II
31. Laboratory test methods
32. What not to validate?
33. Summary
34. Review

STAGES OF VALIDATION
35. Introduction
36. V Model
37. The URS document
38. FAT and SAT
39. Qualification/Commissioning
40. IQ Phase
41. OQ Phase
42. PQ Phase
43. Process validation
44. Validation & SOPs
45. Review of sequences
46. Summary
47. Review

DOCUMENTATION
48. Introduction
49. Validation Master plans
50. Protocols and reports
51. Document linkage
52. Documentation flowchart
53. Managing deviations
54. Summary
55. Review

CHANGE CONTROL
56. Introduction
57. Importance
58. Types of changes
59. Summary
60. Review

COURSE OBJECTIVES:


Define some important validation terms.
Describe the development of validation and regulatory control.
State the reasons for validation.
Describe the difference between critical and non-critical equipment, in terms of validation activities.
Describe the roles of a validation team.
List the scope of validation.
Describe the V model approach to validation.

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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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