Workshop B: Navigating the Impact of Mergers & Acquisitions on GCP Inspections: Strategies for Compliance and Continuity
Session details:
This session explores how mergers and acquisitions influence Good Clinical Practice (GCP) inspections, highlighting the challenges and opportunities that arise during organizational changes. Participants will learn best practices for maintaining compliance, preparing for inspections, and ensuring seamless integration of quality systems amidst M&A activities. Join us in this extremely interactive workshop (audience participation is highly welcomed) to understand the regulatory implications, risk mitigation strategies, and practical approaches to sustain GCP standards throughout the transition process. Some of what we will discuss and share, include:
- Best practices and battle scars from those who have gone through this or are preparing to go through this
- Integration challenges with differing processes, systems and personnel
- The human factor – what to do when sources of knowledge have walked out the door
- Understanding the initial uncertainty and potential disruptions during an M&A can increase the risk of GCP violations if not managed effectively
- Inspection readiness – being prepared for inspections by addressing any gaps in quality systems and ensuring all stakeholders are involved in preparing for inspection
- The impact to documentation processes
- Managing effective communication and coordination
- Focusing on integrating key GCP-related processes, systems and personnel early in the M&A process
- Implementing regular monitoring and auditing to always be prepared for inspections
- And much more…
Our goal is for this to be a benchmarking exercise where everyone can walk out with something in their hands to make sure they are/will be inspection ready and prepared when an M&A comes your way.
