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    Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification

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    Website http://complianzworld.com/Webinars.aspx?TopicId=499&Sub=Qualification-Sample-Size-and-Statistical-Co | Want to Edit it Edit Freely

    Category webinar, qualification, pharma, process, performance

    Deadline: September 26, 2014 | Date: September 26, 2014

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

    Updated: 2014-08-22 02:32:06 (GMT+9)

    Call For Papers - CFP

    Description:

    The demonstration of process capability and process stability poses some challenges for some manufacturers of Pharma products as they transition from Stage 1 ? Process Design to Stage 2 ? Process Qualification including that Stage 2 ? Process Qualification applies to both new product launches and legacy products under change control. The FDA and ISPE have provided the following three key references to sort through requirements and expectations:

    Course Objective:

    ? To get an overview of Stage 2 ? Process Validation by seeing practical examples that you can apply when validating your products.

    ? To get a refresher of the approaches and statistical calculations required to execute Stage 2 ? Process Qualification based upon statistical confidence.

    ? To connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.

    Course Outline:

    ? Overview of FDA Guidance

    ? Process Capability

    ? Process Stability

    ? Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence

    ? Confidence Level

    ? Risk and Confidence Level

    ? Example Confidence Equations

    Target Audience:

    ? Quality Assurance

    ? Validation

    ? Regulatory

    ? Validation Managers

    ? Validation Engineers

    ? QA and Auditing Professionals

    ? Regulator Professionals

    Webinar price Tags :

    $ 229.00 Single Attendee

    $ 749.00 Group ? Max 10 Attendees per location

    $ 269.00 Access Recorded Version online

    $ 399.00 Buy Training CD-DVD

    For More Details or Enrollment Or Registration :

    Contact : complianzworld

    Phone : +1-866-978-0800

    Fax : +1-888-883-7697

    E-mail ID : webinarhelpatcomplianzworld.com


    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.