2012 - Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel

Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.
This webinar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.
Reference material for easy implementation:
SOP: Validation of Analytical Methods
Checklist: Validation of Analytical Methods
65-page Primer: Validation of Analytical Methods
Areas Covered in the Session:
FDA regulations and guidelines
Examples of warning letters and how to avoid them
USP Chapters and ICH Guides
Developing an SOP for method validation
Development of a validation plan for success
Prerequisites for method validation
Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
Defining test conditions and acceptance limits
Verification of compendial methods according to USP <1226>
To revalidate or not after method changes
Transferring a method to routine according to USP <1224>
Seven most common method validation pitfalls and how to avoid them
Using software for automated method validation
Documentation for the FDA and for other agencies
Who Will Benefit:
Laboratory managers and supervisors
GLP/GCP/GMP auditors
ISO 17025 auditors
QA/QC managers and personnel
Analysts and other laboratory staff
Regulatory affairs
Training departments
Consultants
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884