Transfer of Analytical Methods and Procedures:FDA Requirements and Strategies and Tools for Implementation
Instructor:
Dr. Ludwig Huber
Product ID: 700632
- Duration: 60 Min
Why Should you Attend:
Until recently there was no specific FDA guidance on what exactly is expected to maintain 'the validated state'. Now the FDA has released an official guidance on how to conduct and document method transfer for specific applications. Attendees of this Webinar will learn how to transfer analytical methods in FDA and equivalent international environments.
Areas Covered in the seminar:
- FDA and International regulations for method transfer
- Examples of FDA warning letters and how to avoid them
- The new FDA Guidance on method transfer
- Developing an SOP and SOPP and transfer plan
- Responsibilities of the transferring and receiving laboratory
- Method transfer options
- Criteria for transfer waiver (omission of formal transfer)
- Types of method transfer and testing
- Conducting comparative studies
- Most likely failures during method transfer
- Handling deviations
- Method transfer protocol and summary report
Who Will Benefit:
- Everybody involved in method validation
- Laboratory managers and staff
- Analysts
- QA/QCU managers and personnel
- Regulatory affairs
- Training department
- Documentation department
- Consultants
Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems". For more information, visit Dr. Huber’s website: www.ludwig-huber.com.
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