Validation of Bioanalytical Methods and Procedures for FDA Compliance -Webinar By GlobalCompliancePanel

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Phone: 800-447-9407

RAPS Approved Webinar on
Validation of Bioanalytical Methods and Procedures for FDA Compliance
Date: Wednesday, October 10, 2012
Time: 10:00 AM PDT | 01:00 PM EDT
Course "Validation of Bioanalytical Methods and
Duration: 75 Minutes
Procedures for FDA Compliance" has been pre-
Instructor: Dr. Ludwig Huber
approved by RAPS as eligible for up to 1.25 credits
Location: Online
towards a participant's RAC recertification upon full
completion.
Price : $245.00 (for one participant)
Dr. Ludwig Huber
Chief Advisor - Global FDA
Register Now
compliance, Agilent Technologies
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. ...more
Overview:
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 analyte. 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.

Areas Covered in the Session:
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FDA regulations and guidelines
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Understanding the FDA and EMA Guidances for
Bioanalytical Method Validation
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Phased approach for validation during drug
development
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Logistics of validation
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Development of a master plan and SOP for
validation
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Preparation and use of reference standards and
equipment
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Defining parameters and acceptance limits
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Defining validation experiments
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Documenting and archiving raw and source data
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Considerations for Microbiological and Ligand-
binding Assays
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Working with QC samples for quantitative routine
analysis
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To revalidate or not after method changes
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Transferring and using the method to routine
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Using computers for automated method validation
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Documentation for the FDA and other agencies
Who Will Benefit:
Suggest a Topic
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Laboratory managers and
supervisors
More Webinars
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GLP/GCP/GMP auditors
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QA/QC managers and
personnel
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Analysts and other
laboratory staff
Click here to
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Regulatory affairs
register for this
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Training departments
webinar
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Consultants
It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator


GlobalCompliancePanel
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
for online compliance training by creating a single window of learning opportunities for compliance
professionals & providing a forum for expert speakers/panelists to render their services through simplified
online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of
best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance
professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all
sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal
ensures a secure & cost effective online environment and also support your E-learning and development
on/through our website. Keep track of all webinars arranged for your industry through notifications & event
calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.

GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
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