Student Login |


Friday, November 16, 2018
Home » Online Training Course

Validation: Operational/Performance Qualification Protocols (VAL04)

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: Operational/Performance Qualification Protocols
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 operational qualification (OQ) and performance qualification (PQ). The entire program must be viewed by students. In order to pass, a multiple-choice, online final assessment must be accomplished with a passing grade of 80% or more.

Course objectives include the following: To illustrate a compilation of an OQ and PQ report, to demonstrate the preparation, approval, and execution of an OQ/PQ protocol, to offer a summary of the key differences between PQ and OQ, to identify and explain the responsibilities of PQ and OQ, to identify and explain the activities to be carried out during PQ and OQ, and to identify and explain the scope of PQ and OQ.

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 an introduction to PQ and OQ, PQ Phase, OQ Phase, and a conclusion involving review, resources, and glossary.

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. Through the years, the BioPharma Institute has compiled a comprehensive offering of effective training tools and proven techniques used to instruct the various aspects of specific job functions and industry applications as they apply to the biotechnology, pharmaceutical, and healthcare industries. We have effective, convenient, and efficient training solutions for professionals who work in those industries and want to sharpen their skills, take a refresher course, or continue/further their education.

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: Operational/Performance Qualification Protocols 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:


INTRODUCTION TO OQ/PQ
1. Welcome
2. Outcomes
3. First Class Pharmaceuticals
4. Meet the V Team
5. The new line
6. Definitions

OQ PHASE
7. The scope of OQ
8. OQ responsibilities
9. Typical responsibilities of the vendor
10. Definitions
11. Protocol design considerations
12. OQ activities
13. OQ tests
14. Test requirements
15. Executing the protocol
16. Final OQ report
17. Review

PQ PHASE
18. The scope of PQ
19. PQ responsibilities
20. PQ steps
21. PQ activities
22. Microbial monitoring
23. Other considerations
24. Executing PQ 1
25. Executing PQ II
27. OQ/PQ comparison
28. Documentation requirements
29. Final PQ report
30. Review

CONCLUSION
31. Summary

GLOSSARY/RESOURCES
Glossary
Resources

COURSE OBJECTIVES:


–Identify and explain the scope of OQ and PQ.
–Identify and explain the activities to be carried our during OQ and PQ.
–Identify and explain the responsibilities of OQ and PQ.
–Summarize the key differences between OQ and PQ.
–Prepare, approve, and execute an OQ/PQ protocol.
–Compile an OQ and PQ report.


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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us
with as much detail as possible about your training project):