Event Calendar

GCP and Audit Preparedness

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2019 Agenda


Friday, September 27, 1:15-2:00

Investigator / Investigational Site Responsibilities

Mr. Rashti will highlight the importance of investigator and investigational site responsibilities, and relate Good Clinical Practice compliance to successful completion of clinical studies in support of New Drug Applications. Mr. Rashti will describe how to prepare for an audit by FDA staff, most common deficiencies observed, and how to avoid them. Past audit experiences will be shared. 409

Presenter: Mike Rashti, BS, President, BIMO Auditor and Trainer, LLC

Track: GCP and Audit Preparedness


Friday, September 27, 2:05-2:50                             

Dealing with an FDA Inspection: Expectations, Outcomes & Consequences

This session will describe the preparation of a site for an FDA inspection and how to successfully host an audit. Mr. Hamrell will cover the audit from different perspectives and focus on helpful hints and procedural issues regarding what to do if chosen for an FDA inspection. There will be a discussion on how to host the inspection and how best to prepare for the actual event. The audience will be taught some of the dos and don’ts of a successful inspection and will learn from actual case examples and inspections. 411

Presenter: Michael Hamrell, PhD, RAC, FRAPS, RQAP-GCP, CCRA, FACRP, President, MORIAH Consultants

 Track: GCP and Audit Preparedness


Friday, September 27, 3:25-4:10                                 

What to Expect from an FDA Inspection

The FDA notifies you they are coming to inspect.  What do you do next? This presentation will go over what to plan for, before the FDA Inspector arrives on site, what to expect when the inspector arrives in person, what to expect during the inspection process, and what to expect at the conclusion of the inspection. 413

Presenter: Donna Williams, BS, CCRP, RN, Project Administrative Officer of Clinical Trials, SUNY Upstate Medical Hospital / Cancer Center 

Track: GCP and Audit Preparedness


Friday, September 27, 4:15-5:00                              

Study Team Training as a Result of Audit Findings in Oncology Trials

Study Team Training as a Result of Audit Findings in Oncology Trials
We all love audits. How can we make the results of audits productive and informative? Ms. Rowell and Ms. Chang will help attendees learn how to take oncology clinical trial audit findings and create study team trainings to fulfill the corrective action plan and not have issues in the future. 415

We all love audits. How can we make the results of audits productive and informative? Ms. Rowell and Ms. Chang will help attendees learn how to take oncology clinical trial audit findings and create study team trainings to fulfill the corrective action plan and not have issues in the future. 415

Presenter: Amy Rowell, MS, CCRP, Quality Assurance Coordinator, UT Southwestern

Presenter: Jenny Chang, BA, Quality Assurance Coordinator, UT Southwestern

Track: GCP and Audit Preparedness