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This seminar will help all personnel involved in proposing, assessing, and implementing changes to understand and successfully apply Change Control best practices. Key focus will be placed on change proposals, justification / risk assessment and change execution / implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed. Techniques for assuring robust Change Control programs in light of COVID-19 restrictions will also be discussed.
This is a practical how-to course, designed to provide participants with skills they can immediately apply to change controls within their own organizations. Case studies will allow participants to practice skill sets in cooperation with the instructor.
Upon completing this course, participants should be able to:
This course is designed for people tasked with:
The following personnel will benefit from the course:
For More Information:
Change proposal authors, Change control system owners, Validation staff /management, QC staff / management, Regulatory Affairs staff / management, QA staff / management