Bioanalysis Zone

Expert Series: Analytical method transfers: practice and pitfalls


Speaker: Wayland Rushing

hhOver his career, Dr. Wayland Rushing has led CMC development programs for a wide array of pharmaceutical products, including parenterals, inhalation drugs, drug/device combinations and other therapies with complex delivery systems. Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, stability testing, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions. Dr. Rushing is a co-author of PDA Tech Report 65, Technology Transfer and Tech Report 76 on Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging

In this webinar Wayland Rushing outlines the common pitfalls that result in method transfer failures and how to avoid them. He explains how the transfer of analytical methods is often overlooked until a method doesn’t perform as expected and can take precious days of investigative work to find the problem, and even more to correct it.

Highlights include:

  • There will be a lot of analytical transfer between R&D labs, contract labs, manufacturers and QC testing labs.
  • Having an efficient transfer team is important.
  • It important the receiving unit has additional data to really understand the analytical method
  • The data transferred needs to be representative and should include a list of encountered issues.
  • Receiving units should not be afraid of asking questions
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