The FDA Aseptic Manufacturing Guidance - By AtoZ Compliance
WebcastFaculty
OVERVIEW
The FDA Aseptic Manufacturing Guidance - By AtoZ Compliance is organized by AtoZ Compliance and would be held on Apr 13, 2017. The target audience for this medical event are Employees, Supervisors, and Managers involved in Aseptic Processing,
Quality Personnel involved with Reviewing Procedures, Batch Records, and Results associated with Aseptically Processing Drug Products.
The process of aseptic fillingoperations of final drug products is not an easy task. The FDA Aseptic manufacturingguidance document gives guidance when it comes putting the proper procedures and controls into place for preventing harm to a patient related to aseptic processing.By understanding how final drug product is aseptically processed, pharmaceutical companies can implement many of the controls described in the FDA aseptic processing guidance document.
Learning Objectives
• Understand what the Aseptic Processing Guidance document is used for
• Understand the concepts described in the Aseptic Processing Guidance Document
• Implement the proper controls to prevent the problems associated with aseptic processing
Areas Covered
• Brief history of reason why the Aseptic processing guidance document is important
• Brief overview of the Aseptic Processing Guidance Document – Sep 2004
• Reviewing the concepts outlined in the Aseptic Guidance document and ways to implement the concepts described in the guidance document
• Validation of Aseptic Processes
• Examples on how the concepts outlined in the Aseptic Processing Guidance document can be implemented
The process of aseptic fillingoperations of final drug products is not an easy task. The FDA Aseptic manufacturingguidance document gives guidance when it comes putting the proper procedures and controls into place for preventing harm to a patient related to aseptic processing.By understanding how final drug product is aseptically processed, pharmaceutical companies can implement many of the controls described in the FDA aseptic processing guidance document.
Learning Objectives
• Understand what the Aseptic Processing Guidance document is used for
• Understand the concepts described in the Aseptic Processing Guidance Document
• Implement the proper controls to prevent the problems associated with aseptic processing
Areas Covered
• Brief history of reason why the Aseptic processing guidance document is important
• Brief overview of the Aseptic Processing Guidance Document – Sep 2004
• Reviewing the concepts outlined in the Aseptic Guidance document and ways to implement the concepts described in the guidance document
• Validation of Aseptic Processes
• Examples on how the concepts outlined in the Aseptic Processing Guidance document can be implemented
SPECIALITIES
Infectious Disease
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