Change Control Best Practices: Proposals and Execution
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Website http://www.onlinecompliancepanel.com/webinar/ChangeControlBestPractices-501057/OCT-2015-ES |
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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 ExecutionInstructor: Andrew CampbellProduct ID: 501057Level: IntermediateDescriptionFDA 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 CoveredOverview of Change Control regulatory requirementsWhat/why Change Control?Types of changes subject to Change ControlChange ProposalChange Assessment (Risk, Impact)Approval to execute changeExecuting the changeImplementing the changeChange Control DocumentationObjectives of the PresentationLearn the basic regulatory requirements for Change ControlLearn how to determine what type of changes require Change ControlLearn the fundamental steps of the Change Control ProcessLearn how to author a Change ProposalLearn how to assess a Change ProposalLearn how to execute and implement a proposed changeLearn the key elements to include in Change Control DocumentationLearn how to identify and avoid potential pitfalls during the Change Control ProcessWhy Should you AttendThis 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 BenefitChange 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 ChangesQuality Assurance Quality Assurance/Management personnel with ownership of Change Control SystemsFor Registration -http://www.onlinecompliancepanel.com/webinar/ChangeControlBestPractices-501057/OCT-2015-ESNote : Use coupon code 1371 and get 10% off on Registration
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