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Tuesday, December 11, 2018
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Validation: Computer Systems – Part II (VAL10)

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: Computer Systems – Part II
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 training program builds upon Computer Systems Validation Part l (VAL09). It offers an introduction to computer systems validation as required by GxP regulations. Course objectives include the following: to provide a description of the legacy systems and how to perform retrospective validation, to offer a method of determination of the amount of validation required and strategy for usage, to provide a description of which systems to validate, and to offer a description of each of the phases in the computer systems life-cycle. The entire program must be viewed by students. In order to pass, a score of 80% or better is necessary on a multiple-choice, online final assessment.

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. Following a brief introduction, topics covered in this course include legacy systems, maintenance/operations phase, validation phase, install/develop/design, and a conclusion that summarizes the previously listed topics.

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 interested 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. Let the BioPharma Institute assist your employees, your colleagues, and you in learning all about the ins, the outs, and the peripheral regulations involved in the biotechnology, pharmaceutical, and healthcare industries.

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: Computer Systems – Part II 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. Introduction
4. The validation project
5. Computer Systems Lifecycle
DESIGN/DEVELOP/INSTALL
6. Introduction
7. Deliverables.
8. Design specifications
9. Development testing
10. Test plans
11. Test cases and scripts
12. Good testing practices
13. Test documents
14. Change management
15. Summary
16. Review
VALIDATION PHASE
17. Introduction
18. Deliverables
19. Computerized systems
20. Timeline
21. Platform qualification
22. Application IQ
23. OQ
24. PQ
25. Change Management
26. Validation report
27. Test scripts
28. Summary
29. Review
OPERATIONS/MAINTENANCE PHASE
30. Introduction
31. Deliverables
32. Operational lifecycle
33. Change control
34. Summary
35. Review
LEGACY SYSTEMS
36. Introduction
37. Legacy systems
38. Retrospective validation
39. Summary
40. Review
41. Conclusion
42. Summary

COURSE OBJECTIVES:


–Describe each of the phases in the Computer Systems Lifecycle
–Describe which systems to validate
–Determine the amount of validation required, and the strategy to use
–Describe legacy systems and how to perform retrospective validation


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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