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Saturday, June 24, 2017
Home » Online Training Course

Validation: Master Plans and Documentation (VAL02)

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: Master Plans and Documentation
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This online program offers an introduction to the international principles and regulations behind effective validation of master plans and documentation. The entire program must be viewed by students. In order to pass, an 80% or better score on a multiple-choice, online final assessment is required.

Course objectives include the following: Demonstrate how to apply the change control program to maintain items in a validated state, to show how to develop and publish validation document, to illustrate how to prepare a responsibility matrix and validation schedule, to demonstrate how to determine the content and scope of a VMP, and to explain why a VMP is important to validation management.

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. The dinaris.org has both the course content and experience required to deliver the high-quality training that your colleagues, your employees, and you could use to succeed in achieving corporate objectives and advancing careers. Our proven techniques can assist you and your company in your biotechnology, pharmaceutical, and healthcare educational needs.

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: Master Plans and Documentation 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

COURSE OUTLINE:


VALIDATION MASTER PLAN
1. Outcomes
2. First Class Pharmaceuticals
3. Introduction
4. Definitions and standards
5. The new line
6. Glossary of terms
7. VMP Structure
8. Importance of VMP
9. VMP and responsibilities
10. Regulatory requirements
11. VMP sections
12. VMP content
13. Summary
14. Review
SCOPE OF THE VMP
15. Introduction
16. Using risk assessment
17. Defining risk
18. Critical vs non-critical
19. Risk assessment approach
20. Validation strategy
21. Validation policies
22. Qualification phases
23. Equipment qualification
24. Developing a plan
25. Summary
26. Review
VALIDATION DOCUMENTATION
27. Introduction
28. Documentation overview
29. Interrelations
30. Reference documents
31. Authorizing validation
32. Organizing validation
33. Using protocol templates
34. Change control
35. Required procedures
36. Handling deviations
37. Validation data
38. Tracking and cataloguing
39. Archiving and retrieving
40. Report and certification
41. Summary
42. Review
CHANGE CONTROL
43. Introduction
44. Change management
45. Reporting rules
46. Summary
47. Review

COURSE OBJECTIVES:


Explain why a VMP is important to validation management.
Determine the scope and content of a VMP.
Prepare validation schedules and a responsibility matrix.
Develop and publish validation documentation.
Apply the change control program to maintain items in a validated state.

JOB POSTINGS:

4295 QA QC Quality jobs found.
Displaying jobs #1-4.

Quality Supervisor
Posted Date: 2017-06-21
Ultimate – United States, CA, Camarillo, 93010

Assistant Quality Manager
Posted Date: 2017-06-20
CSL Plasma – United States, FL, Miami, 33222

Director, Quality VA
Posted Date: 2017-06-19
Blood Systems – United States, VA, Richmond, 23214

Quality Engineer
Posted Date: 2017-06-20
Apex Life Sciences – United States, NC, Whitakers, 27891

See more QA QC Quality 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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