2021 Full Program Replay

Jan 12, 2021 ‐ Sep 30, 2021



Products

Sharing Site Secrets: Our Experience with More than 15 FDA Inspections

Preview Available

Sharing Site Secrets: Our Experience with More than 15 FDA Inspections

Sep 23, 2021 2:45pm ‐ Sep 23, 2021 3:45pm

The most stressful moment in a site’s research experience just might be the first time you learn that you’ve been selected for an FDA inspection. Panic from not knowing what to expect may hinder an organized and thoughtful approach to preparing for and hosting that inspection. But, what if an institution that has 4-6 inspections every year shared their experiences, and how, in response to those experiences, they now plan and prepare for, host, and manage post-inspection responsibilities? This session will do just that. This session will demystify the inspection process from a site perspective and give your site a confident and organized plan to manage your first – or next – FDA inspection.

Speaker(s):
  • Neala Lane, MS, CCRC, Associate Director, Quality Improvement Office, Indiana University

Assessing IRB Process Capabilities: COVID-19 and Beyond

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Assessing IRB Process Capabilities: COVID-19 and Beyond

Sep 30, 2021 11:00am ‐ Sep 30, 2021 12:00pm

As the clinical research industry struggles to determine how, or if, to move forward with clinical trials based on the potential hazards related to exposure to COVID-19, the continued protection of the rights, safety, and welfare of participants must still be the primary consideration. However, even without the added safeguards required during this time, the FDA has historically noted that IRBs are not meeting their regulatory obligations and that Sponsors and Clinical Investigators are not assessing their compliance. As Good Clinical Practice is based on shared responsibilities for ensuring credible data from protected subjects, when an IRB is not compliant, neither are the Sponsors and Clinical Investigators. Examine the requirements for a compliant IRB, methods for assessment, and discuss processes to ensure compliance, collaboration, and communication.

Speaker(s):

Implementing a CAPA System for the Management of Protocol Deviations

Preview Available

Implementing a CAPA System for the Management of Protocol Deviations

Sep 30, 2021 12:15pm ‐ Sep 30, 2021 1:15pm

It is difficult to manage protocol deviations and ensure appropriate corrective and preventive action items are implemented by research sites, and the difficulty increases with the complexity of trial designs. This educational session will present a solution for implementing a CAPA strategy specifically to address protocol deviation management. Sponsor operations teams and clinical research site personnel will benefit from learning practical ways to manage deviations and reduce the risk of further deviations.

Speaker(s):
  • Mindy Ditch, MS, President and Founder, Bloom Clinical Research, LLC

techXpo Session -- Research Ready: Leveraging Technology in the New Research Landscape

Preview Available

techXpo Session -- Research Ready: Leveraging Technology in the New Research Landscape

Sep 30, 2021 1:30pm ‐ Sep 30, 2021 2:30pm

More than ever before, clinical research professionals are increasingly looking for ways to modernize their operations, recognizing that the changes of the past year have accelerated the acceptance and availability of technology that can deliver streamlined regulatory processes. These solutions have enabled capabilities related to decentralized or hybrid trials and can create a more patient-centric experience. However, regulatory compliance is still paramount, and this session will cover how sites can not only maintain but enhance compliance while evolving their research programs to keep pace with the changing research landscape.

NOTE: This session does NOT offer ACRP Contact Hours.

Speaker(s):

FDA Inspections: Understand the Process and Manage the Consequences

Preview Available

FDA Inspections: Understand the Process and Manage the Consequences

Sep 30, 2021 2:45pm ‐ Sep 30, 2021 3:45pm

This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas. Speakers will employ hands-on activities to create corrective and preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters and 483s.

Speaker(s):
  • Janet Holwell, BA, FACRP, CCRA, CCRC, Clinical Research Consultant, Independent Consultant
  • Glenda Guest, BS, CCRA, RQAP-GCP, TIACR, FACRP, ACRP-MDP, Vice President, Assured of Quality Consulting & Training