How to Develop, Implement and Manage an Effective Change Control Program
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Deadline: January 28, 2019 | Date: January 28, 2019
Venue/Country: U.S.A
Updated: 2018-12-30 04:15:39 (GMT+9)
Call For Papers - CFP
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur.At the completion of this course, attendees will be able to:Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records.Understand all the required components of a thorough Change Control record.Understand all the elements of effective Change Control management:How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes.Ensure changes do not negatively impact the business or established marketing authorization.How to incorporate a Quality risk based approach to evaluating proposed changesEnsure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality MetricsKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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