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:
- Understand the purpose of change control
- Understand regulatory requirements and FDA expectations for change control
- Identify what types of changes are /are not subject to change control
- Properly describe changes
- Properly justify changes
- Develop a comprehensive Change Execution Plan
- Conduct a proper change Risk Assessment
- Ensure proper execution of changes
- Ensure proper implementation of changes
- Develop a complete Change Control documentation package
- Utilize critical thinking skills throughout the change control process
- Avoid pitfalls during the change control process
Who will Benefit:
This course is designed for people tasked with:
- Authoring change proposals
- Assessing / approving change proposals
- Executing / implementing changes
The following personnel will benefit from the course:
- Change proposal authors
- Reviewers / approvers of change controls
- Change control system owners
- Production staff / management
- Engineering staff / management
- Validation staff /management
- QC staff / management
- Regulatory Affairs staff / management
- QA staff / management
For More Info:
- Address 6201 America Center Drive Suite 240, San Jose, CA 95002, USA
- Attachments ComplianceOnline-Seminar-Change-Control-Best-Practices-Avoiding-Unintended-Consequences-of-Changes.pdf
- Event Page URL https://www.complianceonline.com/fda-change-control-expectations-best-practices-seminar-training-80244SEM-prdsm?channel=researcheventalerts
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