This 120 minute training course 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. Learn how to identify and avoid potential pitfalls during deviation investigations.
Why Should You Attend:
Observations involving deficient investigations and CAPA systems repeatedly rank among the top three to five observations noted by FDA during inspections, year over year. Failure to perform effective investigations violates GMP requirements, puts patients at potential risk and results in regulatory risk exposure that is preventable. Knowing how to approach deviation investigations in GMP effectively not only minimizes compliance risk, it constitutes sound quality management practice and can reduce the recurrence of problems that can lead to batch rejections and financial losses.Learning Objectives:
- Understand the GMP requirement for deviation investigations
- Learn why Out of Specification investigations are an important special case
- Learn the steps to take
- Learn what tools may help with the investigation
- Learn common reasons FDA cites companies for inadequate investigations
- Learn what makes a good deviation investigation report
- Learn the importance of follow through to ensure corrective actions have been effective and have prevented recurrence
Areas Covered in the Webinar:
- GMP requirement for deviation investigations
- Steps in an effective investigation
- Examples of investigative tools to assist with resolution of deviations
- Common problems and pitfalls in deviation investigation
- The special category of Out of Specification (OOS) investigations
- Writing good investigation reports
- Verifying corrective action and preventing recurrence
Who Will Benefit:
- Quality Assurance professionals
- Manufacturing professionals
- Laboratory managers and analysts
- Regulatory Affairs professionals
Course Provider
David L Chesney,
