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HUM-MOLGEN
-> Events
-> Meetings and Conferences |
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September 11, 2011 |
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webinar web, United States
2011-09-28
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
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 proposal for a new 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
- 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)
Who Will Benefit:- Analysts
- Lab Supervisors and Managers
- QA managers and personnel
- Analysts
- Consultants
- Teachers
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Organized by:
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global compliance panel |
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Invited Speakers:
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Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.
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Deadline for Abstracts:
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2011-09-28
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Registration:
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Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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webinars@globalcompliancepanel.com
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WWW: Kai Garlipp,
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