Webinar on Transfer of Analytical Methods and Procedures according to USP 1224
Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1768 |
Category Healthcare & Safety
Deadline: July 21, 2106 | Date: July 21, 2106
Venue/Country: Online, Canada
Updated: 2016-06-30 18:40:15 (GMT+9)
Call For Papers - CFPDescription : When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter . Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.For easy implementation, attendees will receiveSOP: Transfer of Analytical MethodsChecklist: Transfer of Analytical Methods and ProceduresMaster Plan template and examples: Transfer of Analytical Methods and proceduresAreas Covered in the Session :FDA and International expectations for method transferExamples of FDA warning letters and how to avoid themThe FDA Guidance on method transfer.The USP chapter : history, status, futureFour approaches for analytical method transfer and testingResponsibilities of the transferring and receiving laboratoryDeveloping a transfer plan and a pre-approval protocol Conducting comparative studiesCriteria and approaches for risk based testing: what, when, how much?The importance and selection of acceptance criteriaDealing with technology transfer: validation requirements, regulatory notification.Method transfer from standard HPLC to UHPLC Most likely failures during method transferHandling deviations from documented acceptance criteriaCriteria for transfer waiver (omission of formal transfer)Method transfer protocol and summary reportWho Will Benefit:Lab Supervisors and ManagersQA Managers and PersonnelAnalystsResearch & Development in Pharmaceutical IndustryPharmaceutical Quality ControlContract LaboratoriesCROsConsultantsTeachers
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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