Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Thu, Nov 16, 2017
Length
60 minutes
Product Description

Ensuring Proper Justification and Rationale for Product Release or Rejection


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; however, the difficult part is explaining or justifying why it should be done or why a product should be released or rejected as a result.

Join this session, with expert speaker Danielle DeLucy, MS, where you will learn efficient and complaint ways to justify the validations, changes or deviations in a manner that will explicitly demonstrate why the process was performed the way it was. She will discuss how to analyze product impact to the market, to the patient, system or firm, and how to justify whether a product should be released or rejected.

Session Highlights

  • 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

Who Should Attend

  • Quality assurance/quality control directors, managers and specialists
  • Regulatory affairs/regulatory compliance directors, managers and specialists
  • Engineering/development directors, managers and specialists

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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1-866-458-2965

1-800-508-2592

About Our Speaker

Danielle DeLucy

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous...   More Info
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