Length of Course: Approximate time to complete this course is 2 hour(s).
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
Training Program: Validation: Commissioning and Installation Qualification
Training Provided By: BioPharma Institute
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 commissioning and installation qualification (IQ). The entire program must be viewed by students. In order to pass, a multiple-choice, online final assessment must be achieved with a grade of 80% or more.
Course objectives include the following: To demonstrate preparation and approval of an IQ report, to demonstrate preparation and execution of an IQ protocol, to offer an explanation of the responsibilities and the scope of IQ, to illustrate a determination of qualification requirements based on an impact/risk assessment, to review an explanation of the difference between commissioning and qualification, and to define installation qualification and commissioning activities.
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. Topics covered in this course include detailed sessions involving IQ protocols, scope of IQ, impact assessments, definitions, and outcomes.
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 effective, efficient, and convenient training solutions for professionals who work in the healthcare, biotechnology, and pharmaceutical industries. Over the years, we have compiled a comprehensive offering of effective training tools and proven techniques used to instruct the various aspects of specific job functions and industry applications.
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.
The Validation: Commissioning and Installation Qualification course is found in the following professional certification program(s):
2. First Class Pharmaceuticals
3. Meet the V Team
4. The new line
5. Regulatory definitions
6. Guidance documents
7. V model approach
10. Common interfaces
11. Commissioning/IQ timeline
12. Purpose of commissioning
13. Purpose of IQ
15. Review I
16. FAT and SAT
18. Vendor Responsibilities
19. Commissioning reports
21. Review II
23. Levels of impact
24. System boundaries I
25. System boundaries II
26. The impact assessment
27. Criticality assessment
28. Determining criticality
29. Assessment flowchart
30. Review I
31. The scope of activity
33. Review II
SCOPE OF IQ
35. Essential IQ items
36. Test requirements
37. Calibration requirements
38. Review I
40. Review II
42. Approval of IQ report
43. Conducting the IQ
Define installation qualification and commissioning activities.
Explain the difference between qualification and commissioning.
Determine qualification requirements based on an impact / risk assessment.
State and explain the scope and responsibilities of IQ.
Prepare and execute an IQ protocol.
Prepare and approve an IQ report.
All Courses in the Validation for BioPharma Companies Catalog:
|Validation: Principles/International Regulations: This online training program offers an introduction to the principles behind and the international regulations to assure effective qualification and validation. The entire program must be viewed by students. In ... Learn more|
|Validation: Master Plans and Documentation: 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 ... Learn more|
|Validation: Commissioning and Installation Qualification: This online program offers an introduction to the international principles and regulations behind commissioning and installation qualification (IQ). The entire program must be viewed by students. In order to pa ... Learn more|
|Validation: Operational/Performance Qualification Protocols: This online program offers an introduction to operational qualification (OQ) and performance qualification (PQ). The entire program must be viewed by students. In order to pass, a multiple-choice, online final ... Learn more|
|Validation: Equipment Cleaning Validation: This online program offers an introduction to the international principles and regulations behind equipment cleaning validation. The entire program must be viewed by students. In order to pass, a score of 80% o ... Learn more|
|Validation: Computer Systems - Part I: 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 sys ... Learn more|
|Validation: Computer Systems - Part II: 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 follow ... 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 Support@BioPharmaInstitute.com.