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Friday, November 16, 2018
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Validation: Computer Systems – Part I (VAL09)

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 I
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 computer systems validation. Course objectives include the following: to offer an understanding the computer systems life-cycle and the fundamentals of computer systems validation. The entire program must be viewed by students. In order to pass, a score of 80% or better is required 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: Validation plan and strategy, planning phase, 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. With extensive expertise in the management of both large and small training projects, the BioPharma Institute strives to help professionals with furthering their understanding of the pharmaceutical, biotechnology, and healthcare industries, and uncovering new discoveries. Let the BioPharma Institute assist you, your colleagues, and your employees in learning all about the ins, the outs, and the peripheral technologies within the industry.

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 I 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 Pharmaceutical
3. Meet the V team
4. Introduction
5. Validation project
6. Definition I
7. Definition II
8. What requires validation?
9. Review I
10. Benefits
11. Qualification
12. Risk Management
13. Industry guidelines
14. GAMP categories
15. Review II
16. Summary
17. Review II
PLANNING PHASE
18. Introduction
19. Computer Systems Lifecycle
20. Planning Phase
21. URS
22. Traceability matrix
VALIDATION STRATEGY AND PLAN
23. Validation strategy
24. Regulation assessment
25. ERES I
26. ERES II
27. ERES assessment
28. Supplier audits
29. Audit questionnaire
30. Risk assessment
31. Risk management
32. Selecting a strategy I
33. Selecting a strategy II
34. Validation plan
35. Change management
36. Summary
37. Review
CONCLUSION
38. Summary

COURSE OBJECTIVES:


Understand the fundamentals of computer systems validation.
Understand the Computer Systems Lifecycle


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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