Liz Wool offered a webinar for Investigators, Sub-investigators, Study Coordinators, Research Nurses and Research Coordinators at Columbia's College of Physicians and Surgeons titled, "The Changing Landscape of FDA Expectations: Investigator Supervisory Responsibilities"

Learning Objectives

• Discuss current FDA inspection trends involving Investigators and sites.
• Explain FDAs definition for 'appropriate delegation' of Investigator responsibilities to study staff.
• Identify minimum site standards and procedures the FDA looks for during an Investigator – site inspection.
• Identify minimum site staff

Services offered reach academic centers need to develop infrastructure for clinical research for both industry s and investigator sponsored studies that are compliant with FDA and OHRP regulatory requirements. This includes business enterprise wide analysis, risk assessment, risk identification and risk priority, to strategize the individualized approach to clinical research quality systems development and deployment.

This includes standard operating procedures, work infrastructure and on the job training/ training environments for all staff to support those who execute clinical trials.

Liz wool's experience as both a research nurse at John Hopkins Hospital, in industry and as an educator provides added value to implementing target, specific solutions to both academic health centers and hospitals.

"QD-Quality and Training Solutions, Inc.™ has breadth and depth of knowledge and experience with GCP, clinical trials, and training.  Liz provided quality systems infrastructure support with Clinical Development SOPs and business processes gap analysis and staff training for Elan Pharmaceuticals in 2007. This included development and delivery of a comprehensive and engaging 7 hour GCP Overview class that received high scores on the participant evaluations.

In addition, Liz was a dynamic guest lecturer for my Introductory class at SFSU Clinical Trials Design and Management Certificate Program several years ago, then taught the GCP class, and has returned to the Program to teach the GCP class again."

"I had the great pleasure of working with Liz in the area of Clinical Compliance and she as a GCP, SOP and Clinical Operations trainer. I have attended many of her classes, and, I can honestly say that Liz's knowledge of GCP, drug development and clinical trial management is second to none. She has a great ability to impart this knowledge to others by creating an engaging and fun atmosphere for learning, through interactive and workshop-style presentations and an overall mentor-approach to training."

"Our Clinical Operations Department attended the 3 day Good Clinical Practices Course this year. Liz is an exceptional trainer as she is able to keep the novice on track without losing the interest of the more experienced members of the group. I enjoyed the class and I learned things to!

I followed up with my group who attended the training three days later. The team was uniform in commenting that the three days went quickly, Liz was able to keep the interest of the group focused with interactive exercises, and that if you had to spend 3 days in GCP Training, this was worthwhile training. Several members have commented to me on specifics they have learned and how they will implement their new knowledge in their jobs. "