ComplianceOnline

Transfer of Analytical Methods and Procedures:FDA Requirements and Strategies and Tools for Implementation

Instructor: Dr. Ludwig Huber
Product ID: 700632
  • Duration: 60 Min

Training CD

$350.00
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(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Attendees of this Webinar will learn how to transfer analytical methods in FDA and equivalent international environments.

Description

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.

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

Additional benefits:

  • Attendees will receive the presenter’s SOPs and Master plan template for Transfer of Analytical Methods.

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

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

Instructor Profile:

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.

Follow us :
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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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Great Seminar
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