Successfully Investigating Deviations
Duration : 60 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 facts and objective evidence to arrive at root cause and CAPA.
Course Objectives:
This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations.
Course Outline:
• Review of FDA and Regulatory Requirements for Investigations
• What is the definition of a Deviation?
• Types of Deviations/Identification of Deviations
• Conducting the Investigation
• Interviews – do’s and don’ts
• Source Documents/Evidence
• Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
• 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:
• Deviation Investigators
• Reviewers and Approvers of Deviation Investigations
• Quality Assurance Departments
• Regulatory Affairs Departments
• Quality Control Departments
• Compliance Auditors
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
