Validation of Bioanalytical Methods and Procedures for FDA Compliance

Instructor: Dr. Ludwig Huber
Product ID: 702229
  • 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 version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2012

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Course "Validation of Bioanalytical Methods and Procedures for FDA Compliance" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

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.

Free Handouts:

For easy implementation, Attendees will receive:

  • SOPs: Validation of Bioanalytical Methods
  • Checklist: - Validation of Bioanalytical Methods
  • Master Plan Template with Examples: Validation of Bioanalytical Methods
  • FDA Guidance and Policy: Bioanalytical Method Validation
  • New EMA Guideline on Bioanalytical Methods Validation

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

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 , 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:

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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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