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Webinar On Transfer of Analytical Methods and Procedures acc

This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.

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Webinar On Transfer of Analytical Methods and Procedures acc

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  1. ContactUs:416-915-4458 Webinar On Transfer of Analytical Methods and Procedures according to USP 1224 Presented By Dr. Ludwig Huber Scheduled On : Wednesday, April 22, 2015 at 13:00 Hrs Hosting By Compliance Trainings Please visit us at https://compliancetrainings.com

  2. ContactUs:416-915-4458 WeEmpower,YouComply! Transfer of Analytical Methods and Procedures according to USP 1224 Product Id FDB1453 Category Food, Drugs & Biologics Wednesday, April 22, 2015 at 13:00 Hrs Scheduled On Duration 75 Minutes Speaker Dr. Ludwig Huber Login at https://compliancetrainings.com/siteengine/Login.aspx WebinarDescription: 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 <1224>. 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 In addition the FDA has included requirements for method transfer in its new draft guidance from 2014 on validation of analytical methods.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. Areas Covered in the Session : • FDA and International expectations for method transfer • Examples of FDA warning letters and how to avoid them • The FDA Guidance on method transfer. • The USP chapter <1224>: history, status, future • Four approaches for analytical method transfer and testing • Responsibilities of the transferring and receiving laboratory • Developing a transfer plan and a pre-approval protocol 

  3. Conducting comparative studies • Criteria and approaches for risk based testing: what, when, how much? • The importance and selection of acceptance criteria • Dealing with technology transfer: validation requirements, regulatory notification. • Method transfer from standard HPLC to UHPLC  • 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 • For easy implementation, attendees will receive: • SOP: Transfer of Analytical Methods • Checklist: Transfer of Analytical Methods and Procedures • Master Plan template and examples: - Transfer of Analytical Methods and procedures Who Will Benefit : • Lab Supervisors and Managers • QA managers and personnel • Analysts • Research & Development in Pharmaceutical industry • Pharmaceutical quality control • Contract laboratories • CROs • Consultants • Teachers Price Tags • Live • Single Live : For One Participant • $ 249 • Corporate Live : For Max. 10 Participants • $ 899 • Recording • Single REC : For One Participant - Unlimited Access for 6 Months • $ 299

  4. Speaker Profile Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber's website (www.ludwig-huber.com). To Register This Webinar Please Visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1453 Contact Us For Immediate Assistance @ 416-915-4458 or Mail Us At uttam@compliancetrainings.com support@compliancetrainings.com

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