Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.
Why Should You Attend
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. 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.
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 – dos and don’ts
• Source Documents/Evidence
• Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
• Key Elements of the Investigation Report
Objectives Of The Session
• Discuss what to do when problems occur
• Outline the requirements of the Deviation and procedure including the deviation report
• Choose the most appropriate Root Cause Analysis methods for the situation
• Discuss how to conduct the deviation and the tools to be used in the process
Who Will Benefit
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Regulatory Affairs Managers
- QC Lab staff
Industries who can attend
This 180 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel
Faculty Danielle DeLucy
Danielle DeLucy, MS, is currently an independent consultant to the biologics and pharmaceutical industries specializing in the areas of quality assurance and quality systems. Prior to this role, Ms. DeLucy 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 filling and packaging operations.