Avoid FDA 483 Observations Through Effective Investigation and CAPA Procedures |
September 18th, 2018 // 4:00 pm @ jmpickett
This Expertbriefings.com Webinar will discuss the FDA expectation for thorough and the complete investigation of deviations and follow-up. This is 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 that include root cause analysis and corrective and preventive actions.. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses the adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent similar deviations in the future.
The timely investigation of deviations with appropriate corrective and preventive action is clearly a US FDA expectation and other regulatory bodies. 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. FDA Inspectional observations of inadequate investigations constitute the largest number of observations during the most recent two years.
This course will include a discussion of the Deviation System, the relationship with investigations and the CAPA system, what should be investigated and the level of investigation. Several tools that will lead to the identification of the root cause will be discussd. Recent FDA 483 and warning letter observations will be discussed, analyzed, and used to identify areas where an organization can improve.
Areas Covered in the Seminar:
• 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 problem solving
• Corrective action.
• Preventive Action.
• Verification.
Who Will Benefit:
• Senior Management
• 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
What You Receive
With your order, we would like to offer you these six items at no added cost:
- Powerpoint slides to share
- Downloadable recording or CD
About the Speaker
Dr. John G. (Jerry) Lanese, PH.D. 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 18 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 device 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.
