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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Successful storyboards are written in an active, positive voice while remaining honest and clear. The storyboard should be no more than one to two pages and should include the following:

• A statement indicating that the company self-identified the gap or issue described in the storyboard. Who or what department identified the issue is too much detail. The company self-identified, accepted responsibility, and went forward to mitigate the situation.
• A succinct high-level statement of the issue that was self-identified by the company, including when the self-identification occurred. Depending on the nature of the issue, this can be a year, a quarter of a year, or an exact date.
• Brief background information: not more than one or two paragraphs.
• A list of key actions taken once the issue was identified. These should be short, powerful statements rather than long-winded sentences filled with details.
• All the above should be written using words and phrases with positive connotations such as self-identified, acted, resolved, investigated, placed priority, remediated, resolved, etc.  
• Dates should always be included when available. Make sure that all dates are in chronological order.
• A brief statement regarding the regulatory risk or impact of the issue. This helps the reader understand the gravity of the situation under discussion.
• A reference/documentation list where additional information can be located. Embed links to the information, if possible.
• A list of supporting documents that can be provided to the inspector if requested. Embed links to the documents, if possible.

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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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• Recognize the TMF as the story of the study, showing the good, the bad, and the ugly
• Review proactive and and logistics aspects of a virtual, hybrid, and in-person inspection
• Ensuring the inspection has remote access, training on your system, and access to requested documents 
• Impact of a properly executed inspection
• Managing all internal and external TMF needs

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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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