Areas Covered in the Session:

• FDA and International regulations for method transfer
  
• Examples of FDA warning letters and how to avoid them
  
• The FDA Guidance on method transfer.
  
• The proposal for a new USP chapter
  
• Developing a strategy for analytical method transfer
  
• Developing an SOP for method transfer
  
• Responsibilities of the transferring and receiving laboratory
  
• Developing a transfer plan: contents and approval
  
• The importance of acceptance criteria
  
• Conducting comparative studies
  
• Dealing with technology transfer: validation requirements, regulatory notification.
  
• Method transfer from standard HPLC to (ultra)fast HPLC
  
• Most likely failures during method transfer
  
• Handling deviations from documented acceptance criteria
  
• Criteria for transfer waiver (omission of formal transfer)
  
• Method transfer protocol and summary report

Who Will Benefit:

• QC managers and personnel
  
• QA managers and personnel
  
• Analysts and lab managers
  
• Validation groups
  
• Validation professionals
  
• Training departments
  
• Documentation department
  
• Consultants