This webinar will concentrate on the key attributes of an effective cGMP investigation, the role of management, quality control tools, CAPA effectiveness and Warning Letters associated with cGMP compliance. Attend this training and learn how you can avoid “Inadequate investigations”
WHY SHOULD YOU ATTEND
Any FDA inspection will ask to review your complaints, investigations and recalls. This, with a tour will be their first impression of your organization’s state of compliance. The investigations you performed for unexplained discrepancies and complaints will need to stand alone for an inspector to read and understand. They can and will ask questions for clarification but minimizing the number will not sidetrack their focus.
This webinar will give you a process to establish an effective system of conducting investigations. This includes:
• Why an investigation?
• What is an effective investigation system?
• 21CFR Part 211.192 Requirements
• Steps to follow to conduct a thorough investigation.
WHO WILL BENEFIT
• Site Leaders/Plant Managers
• Directors of Quality and Manufacturing
• Manufacturing Supervisors and Managers
• QA, QC Supervisors and Managers
• Maintenance Supervisors and Managers
• Laboratory Managers and Supervisors
• The benchmarks and best practices for writing thorough and compliant investigations.
• How to determine your organization’s current investigation effectiveness.
• Provide a template that will enable managers and supervisors to write effective investigations.
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