Analytical Method Transfer According to USP General Chapter-1224

This webinar presents a logical, risk-based approach to method transfer based on existing knowledge of method characteristics and effective transfer documentation. The transfer of analytical methods is an important element in the lifecycle management of active pharmaceutical ingredients and pharmaceutical products.Risks in the method transfer process should be considered and mitigated during the planning phase.However, should the method transfer fail, approaches for dealing with this eventuality are discussed.

Areas Covered in the Session :

• Understanding method transfer
• Types of method transfer
  • Comparative testing
  • Covalidation
  • Revalidation
  • Transfer waiver
• Method transfer elements
  • Preapproved protocol
  • Analytical procedure
  • Transfer report
• A risk-based approach to method transfer documentation to de-risk the method transfer process
• Dealing with method transfer failures
• Understand the essential elements of the method transfer process
• Be able to select an appropriate method transfer approach
• Understand how to evaluate risk in the method transfer process
• Have the necessary knowledge to reduce method transfer risk by reviewing method performance, writing suitable method transfer documentation and setting appropriate acceptance criteria

Who Should Attend:

• Analytical Development
• Laboratory Management
• Quality Assurance
• Quality Control
• Staff Managing Outsourced Testing

Course Director: DR. MARK POWELL

Mark Powell set up Mark Powell Scientific Limited to provide technical support for pre-clinical drug development, which may involve short-term help with specific problems or management of the analytical aspects of a development project, for new or existing compounds, as part of a multi-disciplinary team. He has an expertise in analytical method development and validation (including assay of impurities), design of stability testing studies and auditing of contract laboratories. Mark is also an experienced quality auditor, and can perform GMP audits of contract laboratories, including evaluation of compliance with data integrity requirements. He also provides training services, which are accredited by the UK’s vocational skills agency, Cogent SSC, and are designed to ensure that analysts have the necessary theoretical and practical skills to perform their jobs competently. As well as courses in instrumental chemical analysis, He also provides training in basic laboratory skills and technical writing (analytical methods, SOPs and technical reports). Mark has recently been working with Spectroscopy Magazine to write and deliver an on-line training course in UV spectroscopy and has also been asked to provide training on behalf of the chromatography consumable company Hichrom.