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Tuesday, December 11, 2018
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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
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Validation for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

BioPharma Institute LogoTraining Program: Validation: Master Plans and Documentation
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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 BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The BioPharma Institute 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) 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, 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 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.


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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