Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Conference Details:

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

Conference Description:

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. Learn how to identify and avoid potential pitfalls during deviation investigations.

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA continues to find fault with investigations and the stated conclusions. The FDA clearly expects that deviation investigations determine what happened, why it happened, and what was done to prevent it from happening again. Investigations also receive detailed scrutiny during FDA inspections. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Investigations are one of the key metrics that the FDA uses to assess the effectiveness of an organization’s Quality Systems. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.

This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, product containment considerations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and avoidance of investigation bias will also be discussed.

Important Dates:

• Conference start date: January 09, 2025

Conference Information:

• Category: Physical and Life Sciences
• Location: United States
• Website: http://www.complianceonline.com/deviation-investigation-best-practices-ensuring-correct-content-and-conclusions-webinar-training-703538-prdw

Contact Information:

• Address: 6201 America Center Drive Suite 240 San Jose, CA 95002, USA, San Jose, California, 95002, United States