Best Practices for Proper Deviation Management
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Course Description:
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required.
Having a procedure on Deviation Investigations is not enough. It is the content and conclusions of the investigations themselves that truly count. Doing a proper root cause analysis, gathering evidence and ensuring a sustainable corrective action is key to a proper deviation investigation.
This webinar will help attendees understand the fundamental investigation steps and skill sets. Key focus will be placed on identification and initial reporting of deviations, fact/evidence gathering, and arriving at the correct root cause and CAPA. The importance of investigation planning, critical thinking skills and effective preventative action plans will also be discussed.
Why should you Attend?
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Learn how to identify and avoid potential pitfalls during deviation investigations
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
Learning Objectives:
Upon completion of this session, attendees will know the tools to use to investigate deviations and non-conformances. They will understand the proper way to identify and classify deviations and the best methods for arriving at the root cause of the issue. A case study will be reviewed showing the dos and don’ts of the investigation process.
Who will benefit?
- Deviation investigators
- Reviewers and approvers of deviation investigations
- QA staff and management
- Regulatory Affairs staff and management
- QC staff and management
- Compliance auditors
Registration Options
Speaker Details
Danielle Delucy
Pharmaceutical Expert
Danielle DeLucy, prior to this role has been in the industry for 13 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 Lancaster Laboratories, a contract laboratory where she performed various tests for their clients. In the years
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
