17th Annual FDA Inspections Summit

November 16-18, 2022  |  Washington, DC

The 17th Annual FDA Inspection Summit will provide the insights you must know so you can prepare for, and sail through, your inspections into 2023 and beyond. In-person inspections may be back but the FDA’s remote “alternative tools” are also here to stay. Hear about the agency’s use of each and its inspection plans moving forward at the summit. Industry experts, including past and present FDA officials, are the ones presenting and leading “hands-on” sessions. You’ll get valuable, up-to-the-minute intelligence to guide you through current and future inspection-related complexities.

Special offer for AQC Members: 20% off during registration
Contact us to request your discount

Join WCG Avoca for the following sessions:

Wednesday, November 16, 2022

1:00 PM – 5:00 PM

Inspection Readiness Metrics Workshop: How Do You Measure and Assess Inspection Readiness?

Does your organization rely on metrics reported by your eTMF to assess the “health” or “completeness” of your TMF? How reliable are the measures? What do these metrics really tell you about the quality of your eTMF? What about other important documentation not filed in the eTMF — how do you assess whether non-eTMF components of your TMF are inspection ready? These questions and others will be explored in this “hands-on” inspection readiness metrics workshop. During the workshop, participants will learn how to use a metric development framework to define metrics that help answer important key inspection readiness questions identified by workshop participants. Come “roll up your sleeves” and work with your peers to identify metrics that your organization should be measuring to answer key questions about inspection readiness.

Speaker: Linda Sullivan – Senior Advisor, Metrics & Performance Management – WCG Avoca

Thursday, November 17, 2022

11:00 AM – 12:15 PM

Purpose Driven Inspection Preparedness: People, Process and Technology — Critical Components to Success

Success in clinical trial conduct is reliant upon three critical factors: the strength and quality of relationships between the sponsor, the CRO, sites and clinical trial vendors; the proactive establishment of robust processes that build quality into activities from the start; and the ability to leverage technology to predict and support performance of trial activities. In this session, led by the WCG Avoca Quality Consortium, we will connect, collaborate and explore how building quality relationships, planning processes proactively and utilizing current technology solutions equates to inspection success in an environment where we are often doing more with less.

Speakers:

• • • • Trevor Cole – Associate Director, Client Delivery – WCG Avoca
      • Neala Lane – Associate Director, Quality Improvement Office – Indiana University
      • Téa Romero – Client Success Manager – Clario
      • Gary Shorter – Senior Director of Emerging Technology and AI – IQVIA Tech
      • Kamal Sigel – Vice President, Quality – CymaBay Therapeutics. Inc

1:30 PM – 2:30 PM

The Potential — and Limitations — of Technology-Driven TMF Compliance

TMF-readiness is and will remain a key focus for inspections and a key pain point for sponsors and CROs. Can Artificial Intelligence and Machine Learning (AI/ML) or other automation fill this gap? Join us for a discussion of the promise and challenges associated with applying these approaches in a validated environment.

Speakers:

• • • • Michelle Webb – Vice President, Avoca Quality Consortium – WCG Avoca
      • Ted Finlan – Senior Vice President for Project Planning and Administration – Worldwide Clinical Trials

2:45 PM – 3:30 PM

BIMO in Action: AQC Members Share Insights from Their Recent Inspection Experiences

The updates to the Bioresearch Monitoring Program (BIMO) / Sponsors and Contract Research Organizations Program released in September 2021 shed light on FDA’s current thinking on important topics such as the selection and monitoring of clinical investigators and outsourced services. But how have these updates changed today’s inspection experiences? In this session, we will review significant BIMO updates and share feedback from AQC Members’ inspection experiences. Come join the discussion and hear what these companies have learned and how you can leverage their experiences to support your inspection readiness activities.

Speakers:

• • • • Karen Harvey – Senior Director, Avoca Quality Consortium – WCG Avoca
      • Michelle Webb – Vice President, Avoca Quality Consortium – WCG Avoca