USP [1224] Transferring the Method to meet Regulatory Expectations

USP [1224] Transferring the Method to meet Regulatory Expectations is an online event dedicated to the critical points of USP and the regulatory requirements required by the USP and FDA.

USP [1224] Transferring the Method to meet Regulatory Expectations covers topics such as:

  • Regulatory references USP and FDA Guidance
  • Responsibilities of participating parties
  • Approaches to analytical method transfer o Comparative Testing o Co-validation Between Two or More Laboratories o Revalidation o Transfer Waiver
  • Elements of a complete method validation
  • Effective planning, execution, and documentation of method transfer
  • Requirements as outlined in USP
  • Regulatory requirements for analytical method transfer
  • Planning and executing the analytical transfer validation
  • Requirements as outlined in FDA Guidance document
  • Closing the loop on the transfer process

USP [1224] Transferring the Method to meet Regulatory Expectations intended for:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Quality Control Departments
  • Laboratory Managers and Supervisors
  • Compliance Departments
  • Analysts
  • Research and Development Departments
  • Consultants

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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