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    Quality by Design (QbD) for Development and Validation of Analytical Methods

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    Website http://c2gowebinars.com/product/?topic=validation-analytical-methods | Want to Edit it Edit Freely

    Category Houston

    Deadline: June 15, 2016 | Date: June 15, 2016

    Venue/Country: Online, U.S.A

    Updated: 2016-05-07 15:13:19 (GMT+9)

    Call For Papers - CFP

    DESCRIPTION

    Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine. In addition, FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory resubmission and approval. Moreover, the new FDA Method Validation Guide suggests using QbD elements for development and validation. Because there is no or little experience with the QbD approach for analytical methods, the industry has many questions.

    Areas Covered in the Session:

    General principles and key benefits of QbD

    Regulatory background and trends: FDA, ICH Q8/9/10

    Reasons for changing the way we validate methods

    Current applications of QbD in the pharmaceutical industry

    The Application of QbD for analytical methods

    Comparison of the QbD process with ICH Q2 and USP

    Benefits for method transfer and routine use

    Using the lifecycle approach for method design, development and validation

    Developing specifications and, the analytical target profile

    Documenting input variables for risk assessment in fishbone diagrams

    Using the risk assessment prioritization matrix to select the test parameters

    Traditional vs. the QbD process for method parameter optimization

    The method validation and qualification studies

    Using the method in the routine: on-going performance control, review and change control

    Continuous monitoring and improvements

    Documentation requirements

    Defining the Analytical Target Profile (ATP) and design space

    Case studies

    Who will benefit

    QA managers and personnel

    Analysts and lab managers

    Regulatory affairs

    Training departments

    Method development departments

    Documentation department

    Consultants

    From

    Small, midsize and large Pharmaceutical companies

    Development

    API manufacturers

    Contract laboratories

    Clinical research organizations

    Medical device industry

    Free Handouts

    For easy implementation, attendees will receive

    Master plan - Template and examples: Development and Validation of Analytical Methods through QbD

    SOP

    -Development and Validation of Analytical Methods through Quality by Design

    Checklist :

    - Validation of Analytical Methods according to the FDA Guidance 2015

    Webinar includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    75 Minutes Live Presentation

    Certificate of attendance


    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.