Best Practices for Deviation Investigations

This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation.

• Describe what types of deviations exist
• Explain how to conduct a proper investigation
• Learn new tools for proper root cause analysis
• What things to avoid during the investigation
• How to properly document and manage the deviation details
• How to close the deviation and assess impact to the final product.

• Review of 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
• Key elements of the investigation report

FDA, EMA, and other international regulatory agencies require that there be a deviation investigation system as a subsystem of a company's overall quality system. Those involved in performing investigations, review and acceptance of non-conformance investigations, will learn how to conduct investigations, dos and don'ts in interviews, how to determine CAPA and more in this webinar.

• Mid-Level Managers
• Compliance Officials
• Manufacturing Personnel
• Laboratory Personnel

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.