Validation: Operational/Performance Qualification Protocols

Carolyn Troiano

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This online program offers an introduction to operational qualification (OQ) and performance qualification (PQ).

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.

               

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.

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

31. Summary

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Speaker: Carolyn Troiano,

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation. Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.


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