cGMP Water Systems – Are You Ready for the FDA Inspection?

MessageThis Webinar is over
Date Sep 25, 2018
Time (1:00 pm to 2:30 pm)
Cost 13,700.00
Online
All Pharmaceutical products and R & D require USP and FDA Pharmaceutical Grades of Water. It is used as an ingredient, cleaning manufacturing equipment, a key ingredient for Quality tests and sold in containers. If a company cannot meet, maintain and demonstrate the Water Standards legally required, they cannot sell their products. Pharmaceutical employees are required to be knowledgeable about Pharma Water requirements to assure they produce safe products.

The knowledge includes the principles of producing and maintaining the Pharmaceutical grades of water required to established minimal standards and storing it in quantities to meet production needs, distributing it to several points of use while maintaining the minimal chemical and microbial requirements. All Pharma Water Systems will be inspected by the FDA to determine if ALL STANDADS required are met. Pharma employees should be prepared to discuss the Water Systems with the FDA Inspectors.

Areas Covered in the Session :
  • Water Systems Overview and FDA vocabulary
  • Required Systems SOPs and their training
  • Required Quality testing of Pharma Water Systems
  • Water Testing schedules
  • Tests Required
  • FDA Quarterly and Annual data testing summary reports
  • Water sampling details
  • Action and Alert Limits determination and Other Additional Topics

Who Should Attend:
  • Quality Departments
  • Production Departments
  • Regulatory Departments
  • Water Systems Maintenance Departments
  • Quality Sampling and Testing Teams
  • Validation Teams
  • Plant Personnel

 


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