Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations
This webinar addresses the adequate investigation of deviations, an area that is receiving FDA attention as evidenced by citations in Warning Letters and 483 observations.
Why should you attend : Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future.
The investigation of deviations is clearly a US FDA expectation. The international regulatory expectation for a structured approach to investigations that lead to corrective actions and preventive actions is clearly stated in ICH Q10, Pharmaceutical Quality System, and supported in the FDA Guidance to the Industry, Quality System Approach to Pharmaceutical CGMP Regulations.
This course will include a discussion of the Deviation System, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussed. These include: process mapping, brainstorming, cause analysis, cause and effect and the 5 Whys. The investigation system will be integrated with the CAPA and Change Control Systems.
Areas Covered in the Seminar:
What should be investigated - Complaints, audit observations, deviations, discrepancies, calibration out-of-tolerances.
FDA expectations for investigations.
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 most probable cause - data collection, data analysis.
Determining the root cause - cause and effect, Fault tree, 5 Whys.
Corrective action.
Preventive Action.
Verification.
Who Will Benefit:
QA document reviewers
QA personnel responsible for reviewing investigations reports
QA personnel responsible for the deviation and investigations systems
Quality and Operations personnel responsible for investigations
Personnel from all units responsible for initiating investigations
Instructor Profile: John G. (Jerry) Lanese, PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer. He has lectured throughout the world to clients and for major seminar providers. He was voted the best presenter of the year in 2001 by the Institute of Validation Technology. In 2008 he received the Kenneth Chapman Industry Recognition Award.
