This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus on how to avoid the drawbacks that may occur during FDA inspections. We will also discuss some tips and tricks to reduce and eliminate 483 observations. Ensure compliance by learning how to identify and avoid potential pitfalls during deviation investigations.
Areas Covered in the Session :
- Review of FDA and Regulatory Requirements for Investigations
- How do we define a Deviation?
- What are the different types of Deviations and how do we identify them?
- Steps to conducting a successful Investigation
- The do’s and don’ts to Investigation Interviews
- Source Documents/Evidence
- Determining Root Cause and Effective/Sustainable CAPA to avoid 483 observations
- Key Elements of the Investigation Report
Who Should Attend:
- Deviation Investigators
- Reviewers and Approvers of Deviation Investigations
- Quality Assurance Departments
- Regulatory Affairs Departments
- Quality Control Departments
- Compliance Auditors
Course Director: DANIELLE DELUCY
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.