Best Practices for Investigating Deviations during FDA Investigations

OVERVIEW

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

Proper root cause analysis of the issue is necessary to make sure that the firm is focusing on the real problem and subsequently the proper corrective and preventative actions can begin.

This webinar will help attendees understand how to use root cause analysis tools and CAPA plans to successfully resolve deviations and non-conformances.

AREAS COVERED

• 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

LEARNING OBJECTIVES

• 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
• Review and discuss an example deviation using the tools suggested

WHO WILL BENEFIT

Quality Assurance/Quality Control Directors, Managers, and Specialists 

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists 

Engineering/Development Directors, Managers, and Specialists

For more detail please click on this below link:

https://goo.gl/HUHSBS

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882