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

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