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    COURSE "KEY FACTORS TO DEVELOP AN EFFECTIVE CAPA S 2013 - Key Factors to develop an effective CAPA system - Webinar By GlobalCompliancePanel

    View: 209

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

    Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

    Deadline: February 26, 2013 | Date: February 26, 2013

    Venue/Country: California, U.S.A

    Updated: 2013-02-01 13:55:53 (GMT+9)

    Call For Papers - CFP

    Overview: Having an effective CAPA documentation and tracking system are crucial to pharmaceutical operations. This system will allow personnel to identifying the root cause, corrective action taken, and verification stages. This session will discuss important components to create an effective CAPA system, determine different levels of actions to be taken, and training needed to prevent reoccurrence.

    Why Should You Attend: FDA and regulatory agencies are looking closely in how pharmaceutical companies conduct their investigations, and CAPA is viewed as the central component of Quality Management Systems. However, a significant number of FDA_483 observations and Warning Letters cite CAPA deficiencies. This session will also cover regulatory requirement for a CAPA system.

    Areas Covered in the Session:

    Why an effective CAPA system is important

    Roles and responsibilities of manufacturers

    Identifying sources of infractions

    Determining root causes

    CAPA Tracking System and documentation

    Who Will Benefit:

    Laboratory Analysts

    Quality Assurance scientists

    QA/QC Analysts

    QA/QC Managers

    Auditors

    Inspectors

    Pharmaceutical development and manufacturing personnel

    Manufacturers of raw materials and excipients

    Contract laboratory Organization personnel

    Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies, including companies operating under FDA’s Consent Decree on harmonization and optimization of analytical best practices since 2003.

    Price: $225.00

    USA

    GlobalCompliancePanel,

    Livermore Common, Fremont, CA, 94539

    USA Phone:800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    Event Link - http://bit.ly/VcRNsm

    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.