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2021 - Change Control Best Practices - Avoiding Unintended Consequences of Changes

Date2021-05-18 - 2021-05-19


VenueVirtual Seminar, USA - United States USA - United States

KeywordsChange control process; Change execution plan; Warning letter citations


Topics/Call fo Papers

Day 01(7:30 AM to 1:30 PM PDT)
Regulatory Requirements
FDA Change Control Expectations / Warning Letter Examples
Purpose of Change Controls
What is Change Control?
Why / When Change Control?
Physical Changes vs. Document Changes
Change Control Process
Change Control Process Model- Integrated Manufacturers
Change Control Process Model- Sponsor Oversight of CMO Changes
Types of Changes Subject to Change Control
Products, Materials, Suppliers, Processes, Facilities, Equipment, etc.
Like-for-Like Changes
Emergency Changes
Case Study # 1- Change Control: Yes or No?
Change Proposal
Change Proposal Elements
Describing the Change
Case Study # 2- Change Proposal
Change Justification
Change Justification Elements
Change Risk Assessment
Case Study # 3- Change Justification
Change Execution Plan
Change Execution Plan Elements
Case Study # 4- Change Execution Plan
Change Proposal Assessment
SME Assessments (by functional area)
Case Study # 5- Change Proposal Assessment
Day 02(7:30 AM to 1:30 PM PDT)
Change Execution
Key Considerations for Executing Changes
Evidence of Change Completion
Change Amendment / Cancellation
Change Implementation
Key Considerations for Implementing Changes
Assessing Change Effectiveness
Change Control Documentation
Change Documentation Package Elements
Putting It All Together: A System Viewpoint

Last modified: 2021-04-21 22:10:34