GlobalCompliancePanel to organize RAPS pre-approved webinar on "Validation of Bioanalytical Methods and Procedures for FDA Compliance"
"Validation of Bioanalytical Methods and Procedures for FDA Compliance" is the topic of a 75-minute RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on October 10.
- Washington, DC-MD-VA-WV (1888PressRelease) October 10, 2012 - This webinar is aimed at guiding analytical laboratories towards adapting GLP's that help them overcome the challenges faced in analyzing biological fluids.
Analyzing biological fluids is a task fraught with complications for a laboratory. Thereare FDA-stipulatedindustry recommendations for the correct validation of bio-analytical methods, whose aim is to ensure reliability, consistency and accuracy of bio-analytical data. But there is a catch:getting to this is not very easy, because matrices and decomposition products with low concentrations of analyte combine to interfere with the process.
The answer to this problem is implementing Good Laboratory Practices (GLP).
Despite being a solution; implementing GLP's comes with its own set of difficulties and costs. The cost of compliance with regulation for the laboratory goes up by as much as 30 per cent when it is not implemented properly. Also, not implementing it can lead to failures in analyzing biological fluids, attracting penalties.
Handling this kind of situation is what lies at the core of this webinar. This session gives participants a good grasp of GLP regulations and offers recommendations and tools for implementation. For easy comprehension, it gives participants the following reference material:
o SOPs: Validation of Bioanalytical Methods
o Checklist: - Validation of Bioanalytical Methods
o Master Plan Template with Examples: Validation of Bioanalytical Methods
o FDA Guidance and Policy: Bioanalytical Method Validation
o New EMA Guideline on Bioanalytical Methods Validation
These are the areas this webinar covers:
o FDA regulations and guidelines
o Understanding the FDA and EMA Guidances for Bioanalytical Method Validation
o Phased approach for validation during drug development
o Logistics of validation
o Development of a master plan and SOP for validation
o Preparation and use of reference standards and equipment
o Defining parameters and acceptance limits
o Defining validation experiments
o Documenting and archiving raw and source data
o Considerations for Microbiological and Ligand-binding Assays
o Working with QC samples for quantitative routine analysis
o To revalidate or not after method changes
o Transferring and using the method to routine
o Using computers for automated method validation
o Documentation for the FDA and other agencies
When: October 10, 10:00 AM PDT | 01:00 PM EDT
By whom:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems.
He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance.
For whom:
The webinar will benefit
o Laboratory managers and supervisors
o GLP/GCP/GMP auditors
o QA/QC managers and personnel
o Analysts and other laboratory staff
o Regulatory affairs
o Training departments
o Consultants
Duration: 75 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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