Best Practices for Investigating Deviations

Danielle DeLucy

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This webinar will help attendees investigate and write robust deviation investigations.  This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. 

Why should you attend

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.

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

•Key Elements of the Investigation Report[RB1] 

 

Benefits/Target Audience

•Deviation investigators

•Reviewers and approvers of deviation investigations

•QA staff and management

•Regulatory Affairs staff and management

•QC staff and management

•Compliance auditors

Webinar Events
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Training CD-USB

Physical CD-USB of recorded session will be despatched after 72 hrs on completion of payment

Premier pro price: $449 (save 10%)

Recorded video

Recorded video session

Premier pro price: $314 (save 10%)


Speaker: 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, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.


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