Best Practices for Investigating Deviations Write-Ups and Management

Product Id : FDA172
Instructor : Danielle DeLucy
Oct 03, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

Learn to Investigate and Write Robust Deviation Investigations and Eliminate 483 Observations

Deviation investigations are a 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 ensure that the firm is focusing on the real problem, so that  the proper corrective and preventative actions can subsequently begin.

Join this session, where expert speaker Danielle DeLucy will help you understand how to use root cause analysis tools and corrective and preventive action (CAPA) plans to successfully resolve deviations and non-conformances. The session will help you investigate and write robust deviation investigations. Danielle will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations.

Session Highlights

  • Review of FDA and regulatory requirements for investigations
  • Deviation: Definition
  • Deviations: Types and identification
  • How to conduct investigations
  • The dos and don’ts for interviews
  • Source documents and evidence
  • How to determine the root cause and effective/sustainable CAPA in order to avoid 483 observations
  • Investigation report: Key elements

Who Should Attend

  • Deviation investigators
  • Reviewers and approvers of deviation investigations
  • QA staff and management
  • Regulatory affairs staff and management
  • QC staff and management
  • Compliance auditors

Speaker Profile:

Danielle DeLucy,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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