Virtual Seminar 2020 - 3 Hours Virtual Seminar on Successful Deviation Investigations

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.
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.
• What is the definition of a Deviation?
• Types of Deviations/Identification of Deviations
• Conducting the Investigation
• Interviews – dos and don’ts
• Source Documents/Evidence
Speaker:
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,