Event Calendar

GCP Audit Preparedness

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2018 Agenda

2019 Agenda Coming Soon! 

Saturday, September 29, 1:40 to 2:25 

So You Think You Know GCP...

There are many component parts to GCP including FDA regulations, FDA guidance documents, state laws and international standards. There is so much information to digest on GCP that it is easy to get confused on what GCP actually requires and what is simply recommended. This presentation will use a quiz show format to challenge audience members with GCP questions on a variety of topics including informed consent, monitoring, source documentation, subject recruitment, and IRBs. Even experienced clinical research professionals might be surprised by what they think they know and what is actually true. 225

Presenter: Paul Below, MS, CCRA, Director, GCP Training Specialists LLC

Track: GCP Audit Preparedness

Saturday, September 29, 2:30 to 3:15                              

Delegation of Authority: The Importance of Qualifications and Training of Investigator Site Staff 

Mr. Purnell will discuss the importance of qualifications and training of delegated site staff including the purpose of the delegation log and investigator oversight, review of expectations outlined in ICH GCP, and examples of what the FDA looks for during regulatory inspections.  An exercise in verifying compliance for participants will be provided. 227 

Presenter: Terrence Purnell, MS, CCRP, RQAP, GCP, Senior Quality Assurance Auditor, CSL Behring 

 Track: GCP Audit Preparedness

Saturday, September 29, 3:45 to 4:30                                  

The FDA is Coming- How to Prepare Clinical Sites

This presentation describes the FDA inspection process and provides the tools to prepare for a regulatory inspection at your clinical trial sites. Ms. Miller will review the FDA’s most recent warning letters for noncompliance issues noted during FDA site inspections and examine the FDA compliance programs relevant to investigators, sponsors, and CROs. 229

Presenter: Gloria Miller, BS, RAC-US, CQA-ASQ, Consultant, ADAMAS Consulting  

Track: GCP Audit Preparedness

Saturday, September 29, 4:35 to 5:20                               

What to Do When the FDA Just Shows Up

We have all heard that the FDA can show up at our site at any time. Most of the FDA visits we hear about start with a phone call or some notification, which in turn allows the site some time to “prepare”. What do you do when the FDA just shows up? 231

Presenter: Jasmine Neumann, BS, CCRP, Research Regulatory Affairs Coordinator Manager, Banner MD Anderson Cancer Center 

Track: GCP Audit Preparedness