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    THIS PRESENTATION WILL DISCUSS WHAT ADVANCE PREPAR 2013 - Auditing Analytical Laboratories for FDA Compliance - Webinar By GlobalCompliancePanel

    View: 311

    Website http://bit.ly/10KJBAr | Want to Edit it Edit Freely

    Category Webinar, Health, Pharma, Medical Device, FDA, Clinical

    Deadline: June 11, 2013 | Date: June 11, 2013

    Venue/Country: California, U.S.A

    Updated: 2013-05-22 15:38:40 (GMT+9)

    Call For Papers - CFP

    Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted.

    In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be presented.

    Areas Covered in the Session:

    GMP regulations that apply to analytical laboratories.

    Reviewing documentation

    Advance preparation for the audit

    Auditing styles and structures

    Equipment and laboratory instrument qualification.

    What to look for while doing a walk-through.

    Other regulations and standards, including ISO 17025

    Following through on the audit

    Who Will Benefit: This webinar will be of benefit to company auditors who need to investigate the qualifications of contract testing laboratories and internal testing facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them.

    External and Internal Auditors

    Supervisors and Analysts in Quality Control Laboratories and Quality Assurance groups.

    Supervisors and Analysts in Contract Testing Laboratories

    Personnel Responsible for Selecting Contract Testing Laboratories

    Consultants

    Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories .

    NetZealous LLC,

    DBA GlobalCompliancePanel

    161 Mission Falls Lane,

    Suite 216, Fremont, CA 94539, USA

    USA Phone:800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    Event Link - http://bit.ly/10KJBAr

    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.