This webinar will discuss the current regulatory expectations on how a firm identifies deviations, problems and trends, investigates these to determine the cause, and recommends corrective and preventive actions. It will also explain how to complete these actions and demonstrate how the actions accomplishes the intended correction or prevented the repeated occurrence of the problem.
Why Should You Attend :
Inadequate investigation of deviations or discrepancies is one of the most cited FDA observations in recent years. Anyone involved in the production of a pharmaceutical or medical device product should be aware of the deviation investigation and correction process. The webinar will include a discussion on recent FDA warning letter and 483 observations, analysis of the system deficiencies or nonconformance that caused each observation and the firm's corrective action and follow-up.
Attendees will learn more about the system for identifying, investigating and correcting the deviation or eliminating future similar deviations, which is often referred to as the CAPA system. This webinar will also include a discussion on the CAPA system.
Why Should You Attend :
Inadequate investigation of deviations or discrepancies is one of the most cited FDA observations in recent years. Anyone involved in the production of a pharmaceutical or medical device product should be aware of the deviation investigation and correction process. The webinar will include a discussion on recent FDA warning letter and 483 observations, analysis of the system deficiencies or nonconformance that caused each observation and the firm's corrective action and follow-up.
Attendees will learn more about the system for identifying, investigating and correcting the deviation or eliminating future similar deviations, which is often referred to as the CAPA system. This webinar will also include a discussion on the CAPA system.
Areas Covered in the Webinar:
- What should be investigated - complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances
- FDA expectations for investigations and observations
- The investigation/problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success
- Tools for understanding the process - mapping, critical incident, performance matrix
- Tools for understanding the possible causes - brainstorming, is/is not, nominal group
- Tools for narrowing the investigation to the cause - data collection, data analysis
- Tools for determining the root cause - cause and effect, fault tree, 5 whys
- Corrective action
- Preventive action
- Verification
Who Will Benefit:
- QA managers and personnel
- Quality control
- Method development
- Analytical chemists
- Validation specialists
- Laboratory managers and supervisors
- Regulatory affairs
- Training departments
- Documentation departments
- Consultants
Course Provider
John G Lanese,
