Meet our President

Liz Wool
Liz Wool, CCRA. CMT
President & CEO
QD-Quality and Training Solutions, Inc.
Member, Board of Trustees
Association of Clinical Research Professionals (ACRP)

Call Us:

615.732.6035

Office hours: 8:30 am to 5 pm CST.

MCC Member

Engagements 2013

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January, 2013
CAPA Fundamentals Workshop, Developing CAPAs in the GCP Environment Conference
ExL Pharma

February, 2013
Audit-Readiness — Evaluating & Taking Steps to Ensure You Are Audit Ready Webinar
Society of Clinical Research Sites

February, 2013
Vendor Quality Oversight Webinar
DIA GCP SIAC

March, 2013
Reality vs. Perception — What a Site Really Needs To Do To Be GCP Compliant Webinar
Society of Clinical Research Sites

March, 2013
Advanced Clinical Vendor Oversight: Vendor Lifecycle Management
DIA Course

April, 2013
Successful Risk-Based Monitoring Implementation: Effective Strategies and Tactics for Your Organization
ACRP Global Conference

April, 2013
Successful Risk-Based Monitoring Implementation: Effective Strategies and Tactics for Your Organization
ACRP Global Conference

June, 2013
FDA Expectations in 2012: Investigator - Site
Health Care Compliance Association Research Conference

June,2013
Quality Oversight of CROs-Clinical Vendors
DIA Annual Meeting Tutorial

August, 2013
Risked Based Site Management Webinar
Society of Clinical Research Sites

December, 2013
Top 3 Audit Findings and Tips and Tools To Prevent Them Webinar
Society of Clinical Research Sites

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compliance - quality - performance: Time is of the essence (TM)
HomeReferences • Course Testimonials
Course Testimonials


A Good Speaker
"Liz provided an in-house annual GCP training course at my company. Liz is a good speaker and manages the classroom time (presentation, activities and questions) well."

The Current Landscape of FDA Expectations
Laurie LaBue, Clinical Research Manager, Millenium, the Takeda Oncology Company
 
A Great Review of Current Trends
"This course provided a great review of current trends and issues with great discussion –and the next steps to enforce the guidance."

Current Landscape of FDA Expectations: Sponsors & Investigators
Alpana Loomba, Director, Clinical Operations, Portola Pharmaceuticals
 
A Nice Mix of Summary and Philosophy
"This course was a nice mix of summary and philosophy content with specificity, where needed. Liz is a Subject Matter Expert (SME) and a great presenter."

Quality Oversight 101: Developing a Vendor Quality Management Plan
David K. Marks, Senior Director, Quality Management, RPS, Inc.
 
A Very Knowledgeable and Dynamic Speaker
"Liz is a very knowledgeable and a dynamic speaker."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Jeanne Malia, Associate Director, Process Manager, Purdue Pharma
 
An Engaging Trainer
"GCPs are the foundation of our work. This was a good course and great refresher for me. Liz is an engaging trainer"

Erin Herman,
Sr CRA, Tercica

Good Clinical Practices Course ( 3 day course)
 
An Excellent Presenter and Instructor
"Liz is an excellent presenter and instructor. This course provided me with additional knowledge and skills to bring to my job."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Sabrina Covic-Savic, The Medicines Company
 
Current, Up-to-Date and Very Helpful
"Liz provided an in-house development of Monitoring Plans course at my company. The information was current, up-to-date and very helpful. Liz possesses enthusiasm in her training delivery and there was a good variety of teaching methods used throughout the day."

Monitoring Plans: Part I
Nancy Denney, Clinical Research Associate, Covidien
 
Excellent
"This course was excellent."

Good Clinical Practice for Medical Device IDE Trials
Preety Grewal, CRA II, Arthrocare
 
Excellent Information
"Liz’s course provided excellent information that focused on the topics and practical issues."

Current Landscape of FDA Expectations: Sponsors & Investigators
Hong Farling, Clinical Operations, Portola Pharmaceuticals
 
Extrememly Helpful
"This course was extremely helpful. I have experience with a joint FDA and EMA inspection and Clinical Oversight was a critical factor with the CRO. Liz is knowledgeable on this topic and provided good examples in the course. The course handouts were very good and will be useful to take back to my company and use to discuss with the clinical group."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Ron Lang, Senior Director, Quality Assurance, Valeant Pharmaceuticals
 
Fresh Material
"Liz's course provided fresh material and up-to-date with current FDA findings. The tools Liz provided were great to bring back to my company and she provides to course participants 'one hour free consulting' after her course - which I will take her up on! Liz was open on current issues, which is very valuable – maybe uncomfortable for some –but this needs to happen."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Katie Driscoll-Alberta, Senior Director, Worldwide Quality Assurance, GCP & GPvP, Cephalon
 
Good Energy
"Liz has good energy and good examples in this course. I will be able to use the information from this course in my job."

Current Landscape of FDA Expectations: Sponsors & Investigators
Marzena M. Jurek, Clinical Study Manager, Portola Pharmaceuticals
 
Good Practical Examples
"Liz provided thorough explanations to my questions with good practical examples."

Good Clinical Practice for Medical Device IDE Trials
Cheri Gee, Compliance Project Manager, Arthrocare
 
Great
"The course content, handouts and Liz’s instruction/ presentation style were great."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Carol Lewis Cullinan, Senior Director, Clinical Operations, AMAG Pharmaceuticals, Inc.
 
Great Presentation Skills
"Liz’s in-house SOP Writing Course was very helpful and I learned many good tips that I can implement when writing SOPs (e.g. using the process flow map, where to research the regulations, guidances etc). Liz possesses great presentation skills and is able to keep the class engaged. There was good use of exercises, group interaction and lecture."

SOP Writing Course
Jeanne Montgomery, Clinical Trial Manager, Covidien
 
Great Presenter
"This course was a nice mix of summary and philosophy content with specificity, where needed. Liz is a Subject Matter Expert (SME) and a great presenter"

Quality Oversight 101: Developing a Vendor Quality Management Plan
David K. Marks, Senior Director, Quality Management, RPS, Inc.
 
Great Teaching Technique
"The 3 day GCP class moved along with a variety of physical changes (i.e. quizzes, group work, lectures etc). Excellent GCP course. Liz has a great teaching technique and is very motitvating"

Roxanne Coulon
QA Department
Johnson and Johnson Pharmaceutical Research and Development, LLC
Good Clinical Practices Course ( 3 day course)
 
High Marks
"Liz receives high marks for her presentations about informed consents and effective communications."

Stanford Medical Center Oncology Clinical Research Forum --Advanced GCP: Hot Topics!
Mary Jo Lopez, Clinical Research Associate, Enloe Medical Center, February, 2011
 
I enjoyed the class and I learned things too!
"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 too!"

"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"

Elizabeth Lawson, Sr.
Clinical Project Manager, Tercica
Good Clinical Practices Course ( 3 day course)
 
Involved and Enthused
"Liz has great background in many areas of research, enabling her to use concrete examples in her training. She uses multiple teaching techniques to keep the audience involved and enthused. She also provided excellent materials, and has a light-hearted, energetic manner."

Good Clinical Practice for Medical Device IDE Trials
Pam Aakhus, Patient Recruitment Specialist, Arthocare
 
Kept Everyone Engaged
"Liz provided a very good presentation of GCP. Exercises kept everyone engaged and alert"
Virginia Baker
CRA, Tercica
Good Clinical Practices Course ( 3 day course)
 
This was a Great Course
"This was a great course and important content. Please repeat, in brief, at least once per year. Liz's enthusiasm, knowledge of content and relevancy, and interactivity contributed in making this is a great course."

Alyson Falwell, Clinical Trials Supervisor, Pediatric Hematology - Oncology, February 2011
Stanford Medical Center Oncology Clinical Research Forum --Advanced GCP: Hot Topics!
 
Timely Perspective
"Liz’s in-house GCP training course was excellent and provided a timely perspective on FDA inspections. This course will help us to develop our vendor management program."

The Current Landscape of FDA Expectations: Sponsors and Investigators
Laura Mei, Director, Clinical Operations, Alexza Pharmaceuticals, Inc.
 
Tremendous Depth of Knowledge
"Liz has tremendous depth of knowledge in the field, a great resource and it is great to discuss issues with her. I will implement specific strategies discussed in the course in my job."

Current Landscape of FDA Expectations: Sponsors & Investigators
Deb Chapman, Clinical Operations, Portola Pharmaceuticals
 
Very Informative
"This course was very informative with great information. Liz is a very good speaker. As an Outsourcing Manager, I will be able to apply what I learned in this course to my job."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Jan McMenamin, CI Outsourcing Manager, Alcon Laboratories
 
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Random Testimonial

"GCPs are the foundation of our work. This was a good course and great refresher for me. Liz is an engaging trainer"

Erin Herman,
Sr CRA, Tercica

Good Clinical Practices Course ( 3 day course)