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Recorded Webinar
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
As regulations change and become more stringent, one aspect of compliance has not changed, and that is ensuring changes, deviations, validations and risk assessments are done properly and have a proper justification and rationale. It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.
In this webcast, you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate to the reader why the process was performed the way it was.
Areas Covered in the Session:
- How to propose a solution to the problem related to the deviation, change control, risk assessment or validation study
- Determine alternatives or options to the proposed solution
- Analyze costs, benefits, impacts, and risks of the proposed solution
- Validate the solution, assess product impact to the market
- Determine impact to the patient, system or firm as a result of your findings
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