Event Calendar

Compliance / Noncompliance

Download Breakouts Sessions Overview   | Download Schedule of Breakout Sessions   | View Preconference Workshops   | View Conference Schedule

2019 Agenda


Saturday, September 28, 3:45-4:30                                           

Beyond the Matrix - A Quantitative Approach to Compliance Program Management
Every research program, regardless of size, has some level of exposure to compliance risk. One of the challenges of managing this risk is to know how to prioritize limited compliance resources to achieve the most efficient allocation of effort. Mr. Smith will discuss approaches to identify, stratify, and analyze compliance risks. Ways to apply the analysis to management of compliance, education, and operations to establish—and document—an environment of continuous improvement will also be covered. 329
Presenter: Kevin Smith, MS, MBA, CCRP, Research Administrator, Cleveland Clinic

Every research program, regardless of size, has some level of exposure to compliance risk. One of the challenges of managing this risk is to know how to prioritize limited compliance resources to achieve the most efficient allocation of effort. Mr. Smith will discuss approaches to identify, stratify, and analyze compliance risks. Ways to apply the analysis to management of compliance, education, and operations to establish—and document—an environment of continuous improvement will also be covered. 329

Presenter: Kevin Smith, MS, MBA, CCRP, Research Administrator, Cleveland Clinic

Track: Compliance / Noncompliance 


Saturday, September 28, 4:35-5:20                                          

The FDA Is Here - Now What

The FDA’s relationship with the regulated industry seems to be evolving into a dynamic that most companies are still struggling to fully grasp. Ms. Johnson will cover key aspects that only someone who has managed the FDA inspections program, as a Lead FDA Inspector, can provide. This session will be direct, concise, engaging and informative. 331

Presenter: Sylvia Johnson, BS, MS, MBA, President/CEO, JI-Solutions LLC

Track: Compliance / Noncompliance