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Wednesday, April 08, 2020
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IS/IT: Infrastructure Qualification (ISIT2)

Certification Training
Rated 4.11/5
9 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: IT/IS for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $195.00

BioPharma Institute LogoTraining Program: IS/IT: Infrastructure Qualification
Training Provided By: BioPharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. BioPharma Institute Reviews

The IT/IS: Infrastructure Qualification program is an online course which provides an overview covering the basics of infrastructure qualification, both during the ongoing use of infrastructure and during implementation. The final assessment for this course, which is taken online, can be attempted an unlimited number of times until the student receives a passing grade. Once the course requirements have all been satisfied a certificate of completion in PDF format will be accessible. (Students taking the IT/IS Compliance and Qualifications Professional Certification Program may notice that this IT/IS: Infrastructure Qualification Course is found within that program.)

Benefits of Getting Certified at BioPharma Institute

If you are a company or an individual that is seeking online training courses which are recognized by many healthcare, biotechnology, and pharmaceutical companies, the BioPharma Institute is the choice for you. For over two decades we have been training individuals from large corporations to small businesses, helping them to further the skills of their employees, looking to upgrade the quality of work and assure business success.

We provide an e-learning system that is equipped with user-friendly learning tools like high-quality animations, progress checks, books, voiceovers and more. All of these combine to help students understand the various learning concepts. Whether you are enrolling in our pharmaceutical training program as a new employee or simply as a refresher course, you will find our online learning solutions to be comprehensive, flexible, and effective.

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 for more information.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

The IS/IT: Infrastructure Qualification course is found in the following professional certification program(s):

IS/IT Compliance and Qualifications Professional Certification Program: This IS/IT Compliance and Qualifications Professional Certification Program introduces the student to the applicable regulations, how they affect IT, and describes what constitutes applicable regulations. The c ... Learn more


1. Introduction
2. First Class Pharmaceuticals
3. Initial Meeting
4. Meeting
5. What Is Quality?
6. Computerized Systems
7. Components
8. Scope of Qualification
9. Why Qualify?
10. Impact on the Industry
11. Control and Compliance I
12. Control and Compliance II
13. Summary
14. Review

15. Introduction
16. What to Qualify?
17. What is Infrastructure?
18. The Big Picture
19. Platform Life Cycle
20. Activities and Documentation
21. Roles and Responsibilities
22. Good Documentation Practices
23. Review I
24. Summary
25. Review II

26. Introduction
27. Operational Lifecycle
28. Review

29. Summary



Define the terminology of infrastructure qualification.
Identify which infrastructure needs to be qualified.
Explain the Infrastructure Qualification Lifecycle.
Identify qualification activities and documentation.
Identify post-qualification activities required to keep infrastructure in a qualified state.

All Courses in the IT/IS for BioPharma Companies Catalog:

IS/IT: Introduction to Compliance: The IT/IS: Introduction to Compliance Program introduces the student to the applicable regulations which affect IT. These IT services are heavily relied on by companies today. This is why it is so important for ... Learn more

IS/IT: Infrastructure Qualification: The IT/IS: Infrastructure Qualification program is an online course which provides an overview covering the basics of infrastructure qualification, both during the ongoing use of infrastructure and during imple ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, 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 courses: 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
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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

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