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2019 - How to Develop, Implement and Manage an Effective Change Control Program
Date2019-09-19
Deadline2019-09-19
VenueOnline Event, USA - United States 
KeywordsChange control training; Change control record; Change control management
Topics/Call fo Papers
Topic 1: Regulatory Guidance Review
FDA (CFR)
EU (EurdraLex)
ICH Q10
Topic 2: Review all Elements of a Change Control Record
Discuss the importance of utilizing Subject Matter Experts from multiple functional areas 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 changes
Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
Understand what steps should be taken post implementation to confirm the objectives were achieved
FDA (CFR)
EU (EurdraLex)
ICH Q10
Topic 2: Review all Elements of a Change Control Record
Discuss the importance of utilizing Subject Matter Experts from multiple functional areas 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 changes
Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
Understand what steps should be taken post implementation to confirm the objectives were achieved
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Last modified: 2019-08-21 17:30:47