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.
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.
Why Should you Attend:
One of the observations made recently in FDA inspections is inadequate investigation or follow-up. During site inspections, the FDA investigators focus on how the firm identifies, investigates and corrects or prevents deviations. Every firm should have an effective program for deviation identification and investigation. All personnel involved in the production and control of a pharmaceutical product should understand the need to identify deviations, identify the cause and take actions to correct the deviation, and/or prevent future occurrences of the deviation.
Objectives of the Presentation:
The objectives of the presentation are to learn 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 discuss further about the CAPA system.
Who can Benefit:
Personnel in production, quality control, quality assurance, materials, and functions that support these will benefit from this webinar.