Validation of Bioanalytical Methods and Procedures for FDA Compliance

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 702229

Location
  • Duration: 75 Min
This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.
RECORDED TRAINING
Last Recorded Date: Mar-2012

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

Analyzing biological fluids is one on the most difficult tasks in analytical laboratories. Most challenging are interferences from matrices and decomposition products combined with low concentrations of analytes. Correct validation of bioanalytical methods according to recent FDA and industry recommendations ensures reliability, consistency and accuracy of bioanalytical data. But because of the difficult nature of the analysis there are many questions.. This seminar will demonstrate how to validate bioanalytical methods and procedures for FDA compliance.

Learning Objectives:

  • FDA regulations and guidelines.
  • Understanding the FDA and EMA Guidances for Bioanalytical Method Validation.
  • Phased approach for validation during drug development.
  • Logistics of validation.
  • Development of a master plan and SOP for validation.
  • Preparation and use of reference standards and equipment.
  • Defining parameters and acceptance limits.
  • Defining validation experiments.
  • Documenting and archiving raw and source data.
  • Considerations for Microbiological and Ligand-binding Assays.
  • Working with QC samples for quantitative routine analysis.
  • To revalidate or not after method changes.
  • Transferring and using the method to routine.
  • Using computers for automated method validation.
  • Documentation for the FDA and other agencies.

Who will Benefit:

  • Managers and analysts in bioanalytical laboratories
  • Managers and analysts in forensic and toxicological laboratories
  • QA managers and personnel
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants

Instructor Profile:

Ludwig Huber, Ph.D, is Director of Labcompliance and Chief Advisor for global FDA compliance for Agilent Technologies. He is the editor of www.labcompliance.com , 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. For more information, visit Dr. Huber's website: www.ludwig-huber.com

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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