Sign for Notice Everyday    Sign Up| Sign In| Link| English|
Home Post Event 2025Event 2026Event By Topic By Country Contact

Our Sponsors


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

    View: 210

    Website http://bit.ly/I1fAiL | Want to Edit it Edit Freely

    Category online training,Validation of Analytical Methods,FDA Compliance,USP Chapters,ICH Guides,FDA regulations, SOP for method validation

    Deadline: May 24, 2012 | Date: May 24, 2012

    Venue/Country: Online Training, U.S.A

    Updated: 2012-04-17 13:25:03 (GMT+9)

    Call For Papers - CFP

    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

    Thursday, May 24, 2012

    10:00 AM PDT | 01:00 PM EDT

    Price List:

    Live : $245.00

    Corporate live : $995.00

    Recorded : $295.00

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    Phone: 800-447-9407

    Fax: 302-288-6884

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.