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    BIOTECHNOLOGY 2013 - CAPA ? The Heart of Your Quality System

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    Website https://compliance2go.com | Want to Edit it Edit Freely

    Category BIOTECHNOLOGY 2013

    Deadline: July 11, 2013 | Date: July 11, 2013

    Venue/Country: Online, U.S.A

    Updated: 2013-05-03 18:07:41 (GMT+9)

    Call For Papers - CFP

    CAPA systems have come under intense scrutiny by the FDA in recent years. This course will examine the current industry-FDA environment and will give you tools for survival; it will provide a step-by-step guide to the setting-up, operation, management and auditing of a CAPA system for today’s FDA regulated industry environment.

    Section 1: Background-Regulatory Requirements

    ? Why do I need a CAPA System?

    ? Why is CAPA the “Heart” of my Quality System?

    Section 2: What exactly is a CAPA System and what is it supposed to do?

    ? What are the Essential Elements of an effective CAPA System?

    Section 3:

    ? How do I implement an effective CAPA System?

    ? Why all these records; is there an easier way?

    ? How can computer automation help?

    Who Will Benefit

    This webinar will benefit professionals in the following industries:

    ? "Medical Device,

    ? Pharmaceutical,

    ? Human Tissue,

    ? Biotechnology”

    In departments such as:

    ? QA/QC/RA,

    ? Manufacturing/Operations,

    ? Research and Development,

    ? Legal

    With job functions:

    ? Department managers and supervisors,

    ? QA/QC/RA specialists and engineers,

    ? Manufacturing and R&D engineers,

    ? chemists, scientists, formulators,

    ? documentation specialists,

    ? auditors,

    ? technicians

    About Speaker

    Michael has over thirty years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries and has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. Michael has expertise in a wide variety of product and manufacturing technologies and is a recognized expert in quality systems, risk management, software and process validation, and continuous improvement methods. He lectures worldwide for various trade groups.

    Barile & Associates is a consulting firm comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals and provides a broad range of support to the medical device, pharmaceutical, human tissue and biotechnology industries. The firm has capabilities in design and manufacturing engineering, science, statistics, quality systems, process design and validation, computer technology deployment and validation, quality/regulatory crises management and are experts in US FDA and international regulatory requirements

    Speaker : Michael Barile

    Product ID : F62323

    Schedule Date :

    Thursday, July 11, 2013

    duration : 01:00 to 02:30 PM EDT

    https://compliance2go.com/index.php?option=com_training&speakerkey=46&productKey=246

    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.