Best Practices for Deviation Investigations

Duration: 90 Minutes
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.
Deviation Investigations
Instructor: Danielle DeLucy
Product ID: 501204
Objectives of the Presentation
  • 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.
Why Should you Attend
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.

Areas Covered
  • 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
Who can Benefit
  • Mid-Level Managers
  • Compliance Officials
  • Manufacturing Personnel
  • Laboratory Personnel
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
View More