Best Practices for Deviation Investigations
Duration : 90 Minutes
Danielle DeLucy, Pharmaceuticals, Biotechnology
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, suc Read more
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation.
Course Objectives:
• Describe what types of deviations exist
• Explain how to conduct a proper investigation
• Learn new tools for proper root cause analysis
• What things to avoid during the investigation
• How to properly document and manage the deviation details
• How to close the deviation and assess impact to the final product.
Why Should You Attend:
FDA, EMA, and other international regulatory agencies require that there be a deviation investigation system as a subsystem of a company's overall quality system. Those involved in performing investigations, review and acceptance of non-conformance investigations, will learn how to conduct investigations, dos and don'ts in interviews, how to determine CAPA and more in this webinar.
Course Outline:
• Review of regulatory requirements for investigations
• What is the definition of a Deviation?
• Types of Deviations/identification of Deviations
• Conducting the investigation
• Interviews - dos and don'ts
• Source Documents/Evidence
• Determining root cause and effective/sustainable CAPA
• Key elements of the investigation report
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Mid-Level Managers
• Compliance Officials
• Manufacturing Personnel
• Laboratory Personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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