Agenda at a Glance
Pre-Conference Workshop
Monday, May 24, 2021
All Times in Eastern Standard Time
10:00 am EST
Pre-Conference Workshop Begins (Read More)
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
2:00 pm EST
Pre-Conference Workshop Ends
Main Conference Day One
Tuesday, May 25, 2021
10:45 am EST
Opening Remarks
11:00 am EST
Keynote Provided by LMK Clinical
11:30 am EST
Remote Inspections Best Practices: Be Ready for the FDA Drug GMP Facility Evaluations & Inspections During the Pandemic (Read More)
- 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
12:00 pm EST
Networking Break in the Virtual Lounge
12:30 pm EST
Incorporate Mock Inspections into your Inspection Readiness Activities (Read More)
- 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
Sr. Director, Clinical Operations Process, Systems & Inspection Readiness
ACADIA Pharmaceuticals Inc.

1:00 pm EST
Case Study: Planning and Executing a Mock BIMO Inspection (Read More)
- 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
1:30 pm EST
Utilizing Technology to Minimize Inspection Risk During M&A
2:00 pm EST
Networking Break in the Virtual Lounge
2:30 pm EST
Case Study: Enhance your Remote Inspection through People, Process, and Technology (Read More)
- 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
3:00 pm EST
Panel
Inspection Readiness through Proper Operation Management (Read More)
- 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
3:30 pm EST
Day One Concludes
Main Conference Day Two
Wednesday, May 26, 2021
10:45 am EST
Opening Remarks
11:00 am EST
Keynote Presented by CrO Biosciences
11:30 am EST
Indexing Documents Utilizing the TMF Reference Model to Ensure Inspection Readiness (Read More)
- 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
12:00 pm EST
Networking Break in the Virtual Lounge
12:30 pm EST
Key Elements to a Successful Storyboard (Read More)
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.
1:00 pm EST
Panel
Establishing a Culture of Inspection Readiness (Read More)
- 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
1:30 pm EST
Develop a Documentation Plan in support of a Health Authority Inspection (Read More)
- 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
2:00 pm EST
Networking Break in the Virtual Lounge
2:30 pm EST
Leverage your eTMF to Proactively Impact an Inspection (Read More)
- 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
3:00 pm EST
Panel
Inspection Experience (Read More)
- Best practices and shared experiences of remote and hybrid inspections
- Direct access for inspectors
- Communication experiences with regulatory authorities
3:30 pm EST
Summit Concludes