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    Change Control Best Practices: Proposals and Execution

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    Website http://www.onlinecompliancepanel.com/webinar/ChangeControlBestPractices-501057/OCT-2015-ES | Want to Edit it Edit Freely

    Category Change Control, Change Management, Proposal, Execution, Implementation, Impact, Change Risk Assessment, FDA, Compliance, GMP, 483, Warning Letter, Validation, Quality Assurance

    Deadline: October 27, 2015 | Date: October 28, 2015

    Venue/Country: online Webinar, U.S.A

    Updated: 2015-10-06 20:38:55 (GMT+9)

    Call For Papers - CFP

    Change Control Best Practices: Proposals and Execution

    Instructor: Andrew Campbell

    Product ID: 501057

    Level: Intermediate

    Description

    FDA expects changes to be properly justified, reviewed by appropriate subject matter experts, and properly implemented and documented. Furthermore, certain major changes may require regulatory filings and/or prior regulatory approval. A Change Control System should be operated in a manner which assures that these goals are met. It should also produce a documentation package which clearly describes what changed, why the change was made, and how the change was implemented.

    Areas Covered

    Overview of Change Control regulatory requirements

    What/why Change Control?

    Types of changes subject to Change Control

    Change Proposal

    Change Assessment (Risk, Impact)

    Approval to execute change

    Executing the change

    Implementing the change

    Change Control Documentation

    Objectives of the Presentation

    Learn the basic regulatory requirements for Change Control

    Learn how to determine what type of changes require Change Control

    Learn the fundamental steps of the Change Control Process

    Learn how to author a Change Proposal

    Learn how to assess a Change Proposal

    Learn how to execute and implement a proposed change

    Learn the key elements to include in Change Control Documentation

    Learn how to identify and avoid potential pitfalls during the Change Control Process

    Why Should you Attend

    This webinar will help all personnel involved in proposing, assessing, and implementing changes to understand the fundamental Change Control steps and skill sets. Improper Change Control can result in significant compliance and product quality problems, including negative 483 citations, Warning Letters, release of sub-standard product, or product recall.

    Who can Benefit

    Change Control Authors (e.g. Manufacturing, Quality Control, Engineering, Facilities, R & D, Supply Chain Management, etc.)

    Change Control Reviewers/Approvers (e.g. Validation, Regulatory Affairs, Quality Assurance)

    Management of Functional Areas Required to Perform Physical Changes/Document Changes

    Quality Assurance Quality Assurance/Management personnel with ownership of Change Control Systems

    For Registration -

    http://www.onlinecompliancepanel.com/webinar/ChangeControlBestPractices-501057/OCT-2015-ES

    Note : Use coupon code 1371 and get 10% off on Registration


    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.