Change is constant in regulated life sciences environments. Equipment upgrades, process improvements, software updates, supplier changes, and corrective actions all require formal change control to ensure quality and compliance are maintained.
While the intent of change control is to reduce risk, many organizations find that their systems create the opposite effect - long delays, excessive documentation, and cross-functional frustration. Changes stall in review queues, responsibilities are unclear, and teams debate requirements rather than executing improvements. What should be a structured, risk-based process often becomes a bureaucratic bottleneck that slows innovation without necessarily improving control.
This webinar addresses one of the most common root causes of ineffective change control: misalignment between Quality Assurance, Operations, and IT. Each function views change through a different lens. Operations prioritize speed and continuity, QA focuses on compliance and risk mitigation, and IT emphasizes system stability and validation. Without clear ownership and shared decision-making frameworks, these perspectives can conflict, resulting in redundant reviews, inconsistent expectations, and approval delays. Participants will explore how unclear roles and accountability frequently lead to the assumption that “QA owns everything,” creating overload and slowing the entire process.
A central theme of the session is the use of structured, cross-functional risk assessment workshops. Rather than debating requirements after a change is submitted, effective teams collaborate early to evaluate impact, identify risks, and determine appropriate controls. By applying consistent severity, probability, and detectability scoring, organizations can right-size validation and documentation based on actual risk. This approach ensures that low-risk changes move quickly while higher-risk modifications receive the necessary scrutiny.
The webinar also introduces practical tools that streamline decision making. Decision matrices standardize expectations by defining predefined requirements for different categories of change. Instead of arguing about what testing or approvals are needed each time, teams follow clear, risk-based criteria. This consistency reduces subjective judgments and accelerates approvals. Participants will learn how to implement matrices that balance speed with defensibility.
Finally, the session focuses on eliminating approval bottlenecks without sacrificing compliance. Techniques such as parallel reviews, delegated authority, standardized templates, and digital workflows reduce delays while maintaining control. By simplifying documentation and leveraging existing evidence, organizations can avoid over-engineering low-risk changes while still satisfying regulatory expectations.
By the end of the webinar, participants will understand how to create a change control process that aligns functions, clarifies ownership, and supports efficient execution. The result is a system that protects compliance while enabling timely improvements - turning change control from an obstacle into a business enabler.
Why should you Attend:
If your change control process feels slow, confusing, or overloaded with approvals, this webinar will help you fix the root causes rather than add more paperwork. You'll learn how to clarify ownership between QA, Operations, and IT, use risk assessment workshops and decision matrices to standardize expectations, and remove approval bottlenecks without weakening compliance. These practical strategies will help you move changes through faster, reduce frustration, and maintain inspection-ready documentation - allowing your organization to implement improvements confidently while staying fully compliant
Areas Covered in the Session:
