Agenda at a Glance

Key Areas to Adapt to when an Inspection is Conducted Remotely

Remotely conducted health authority inspections are currently necessitated due to the COVID-19 pandemic. However, components of remotely conducted inspections will remain embedded in the future inspection process well beyond the current situation. To ensure that your company is ready for a remote inspection, it must assess current inspection-related processes to be flexible to host one that is conducted all or partially remote. During this interactive workshop we will:

• Identify the areas of biggest change when some or all of an inspection is conducted remotely
• Identify core elements that will need to be changed when all or portions of an inspection is conducted remotely
• Review why the technology aspect of inspections is so much more important and how to support all of those involved
• Explore strategies for how to prepare your organization for the provision of content to be reviewed by remotely located inspectors
• Examine suggestions for preparing for virtually conducted inspection interviews

*This workshop contains a 30-minute break

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• Impact of COVID-19 and a strategic transition to a remote inspection
• Ensure your technology, people, and process strategy is aligned
• Overview and best practices on how to prepare for a remote inspection
• Strategy to ensure your team is prepared for a remote inspection

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• Ensure your mock inspection is properly run to allow your organization to identify gaps, processes, and allow time to remediate activities
• Impact of a robust organizational readiness assessment at the front end of your inspection readiness activities
• Rethink in-person inspections to a remote environment to ensure all SOP and activities can translate to a remote environment
• Utilize the mock inspection to create an outline for your inspection team 
• Lessons learned after having gone through virtual mock and FDA inspections

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• Overview of the plan to put the team through a mock BIMO inspection including identifying a vendor to run the inspection
• Ensure all clinical, document, and quality teams are trained and on-board with the plan to execute the audit along with the site and CRO
• Overview of logistics and technology needed by all team members
• Review of front and backroom team etiquette
• Best practices and lessons learned from the mock inspection

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• Impact of communication to all SMEs and inspection teams in order to prepare for a remote inspection
• Review FDA, EMA, and MHRA guidance for preparing for a remote GCP inspection
• Overview of the process and run a mock inspection to ensure a streamlined inspection
• Understand the technology that will be used and workout the logistics to ensure a seamless process

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• Review your inspection management plan to ensure SME and other colleagues are prepared for the inspection
• Ensure your storyboard outlines the inspection process and properly tells the trial's story
• Anticipate all potential issues and ensure the team is prepared to speak to hot button issues
• Overview of managing the inspection process

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• Utilize the reference model as a foundation to ensure document indexing to Regeneron needs
• Ensure a complete document list
• Review documents to ensure the TMF is inspection ready
• Incorporate reference model updates

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When planning for a regulatory inspection, the ultimate goal is to be fully prepared.  An inspector will leverage the TMF and interviews with study team members to put together a picture of the story of the study.  In order to be fully prepared it is important that we understand the story of our study.  This session will examine strategies for understanding the story of our study and the implications of the story’s alignment with organizational standards, study plans, and the TMF. 

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• Ensure that all stakeholders involved in clinical operations fully understands the importance of inspection readiness from an effective preparation level 
• Impact of reducing time to prepare for an inspection
• Best practices for all teams and stakeholders to understand all SOPs and their impact to a trials inspection
• Setting the foundation and best practices to ensure a culture of inspection readiness

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• Determine Stakeholder Roles and Responsibilities
• Anticipate desired documentation for Inspectors
• What are the Requirements for providing documentation to Inspectors to satisfy both your  organization and the Inspector
• Determine best method to provide Documentation to Inspectors
• Determine your Inspector Access Process according to your organization’s current process and technology

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• Best practices and shared experiences of remote and hybrid inspections
• Direct access for inspectors
• Communication experiences with regulatory authorities

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