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)

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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

QD-Quality & Training Solutions Logo
compliance - quality - performance: Time is of the essence (TM)
HomeTeam • Speaking Engagements
Engagements

Liz Wool is a sought after industry speaker for academic medical centers and professional conferences for her expertise, dynamic and engaging style whereby she 'Translates Regulations Into Practice'™ Course Testimonials are available on our website. QD-QTS provides nursing contact hours 'gratis' for all speaking engagements.

2012 Engagements

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January, 2012
Managing Clinical Programs to FDA/EMA Expectations 2011: Use of Corrective and Preventive Action Methods for Quality and Performance, GCP Developing CAPAs in the GCP Environment
ExL Pharma

March, 2012
Office of Research Integrity (ORI), Quest for Excellence Conference, RCR Training - Is Your Program Employee/Student Performance Based?

April, 2012
Achieving success with implementation of a RBM approach: Effective strategies and tactics for your organisation, Risk Based Approaches to Clinical Trials
London, UK, Informa Life Sciences

April, 2012
Quality by Design: Effective Strategies for Building Quality into the Clinical Trial Process to Identify Minimize and Mitigate Risk
Proactive GCP Compliance Conference, ExL Pharma

April, 2012
Current FDA and OHRP Requirements: What every Research Administrator MUST KNOW!
ACRP Global Conference

May 2012
Prospective Tips for Success: Establishing Quality Expectations of Clinical Vendors and Specialty Vendors
Clinical Operations Summit, Brussels, Belgium, Informa Life Sciences

May 2012
Effective implementation of sponsor-CRO risk-based monitoring programs: Qualifications and training of staff for success!
Clinical Operations Summit, Brussels, Belgium, Informa Life Sciences

May 2012
Implementing a successful performance metrics strategy to drive improvement within clinical trials
Clinical Operations Summit, Brussels, Belgium, Informa Life Sciences

May 2012
Metrics 101: Implementing a successful performance metrics strategy to drive improvement within clinical trials
Clinical Performance Metrics and Benchmarking Summit, ExL Pharma

June, 2012
Quality Oversight of CROs - Clinical Vendors
DIA Annual Meeting, Philadelphia, PA, Tutorial Leader

2011 Engagements

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January, 2011
Optimizing the Collection and Reporting of Metrics
Informa Life Sciences, London, UK

February 4, 2011
Stanford Medical Center Oncology Research Forum, Advanced GCP: Hot Topics!

March 16-17, 2011
DIA Clinical Quality Data Summit, Beyond the CRF and Database

March 31, 2011
IIR Partnerships in Clinical Trials
Prepare Your Site for FDA Audits and Inspections
Phoenix, AZ

April 4, 2011
Proactive GCP Compliance Conference, Trends and Practices for Sites: New or Old?
Notes to File and CAPA, EXLPharma

April 6, 2011
Cincinnati Children's Hospital Medical Center Hospital
Keynote Speaker, Clinical Research Forum

April 30, 2011
ACRP Global Conference, Implementing FDA/OHRP Training Standards: Are You Compliant?
"Live Webcast"

May 1, 2011
ACRP Global Conference , FDA Expectations for Investigator: Are You FDA Compliant?
Seattle, WA

May 18, 2011
ACRP Northern California Chapter, Advanced GCP: Hot Topics 2011!

May 23, 2011
MAGI East
Presenting as a Metrics Champion Consortium Representative,
Philidelphia, PA

May 24, 2011
MAGI East
Session Chair: Electronic Health Records (EHRs) and Clinical Research,
Philidelphia, PA

June 19, 2011
DIA Annual Meeting, Invited Tutorial Faculty, Advanced CRO-Vendor Management Quality Compliance and Performance!
Chicago, IL

August, 2011
Monitoring Plans, ACRP
Charlotte, North Carolina

October 6, 2011
Effective SOPs, Regulatory Requirements, and Process Maps for GCP Vendor Management
San Francisco, CA

October 14, 2011
ACRP Great Missouri Chapter Clinical Research Symposium
Advanced GCP: Source Data/Documentation

October 6, 2011
Advanced Vendor Oversight: Quality Oversight & Quality Management: How to Develop, Implement and Execute an Effective, Risk-Based Vendor Quality Management Plan
Quality Oversight of Clinical Vendors Conference with FDA invited speakers, ExL Pharma

October 22, 2011
Society of Research Administrators International (SRA) Workshop:
Current FDA and OHRP Requirements: What every Research Administrator MUST KNOW!
Montreal, Canada

October, 23, 2011
Standard Operating Procedures (SOPs): The Key to Quality Human Research Protection Programs (HRPPs)
Society of Research Administrators International (SRA), Montreal, Canada

October, 23, 2011
Strategic and Operational Roadmap: Meeting Mandatory Research Staff Training Requirements
Society of Research Administrators International (SRA), Montreal, Canada

November, 2011
Informa Life Sciences Conference: Quality Risk Management for GCP in Clinical Development
Barcelona, Spain

November, 2011
"FDA Expectations for Investigators: Are You FDA Compliant?"
ACRP Southern Wisconsin Chapter

November, 2011
Investigator Supervisory Responsibilities 2011!
ACRP Research Triangle Park, NC

December, 2011
Gathering Data and Producing High Quality Metrics, 7th Annual Clinical Trial Performance Metrics
ExL Pharma

2010 Engagements

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February 24, 2010
FDA Clinical Investigator Inspections Update and FDAs New Expectations for Investigators: 2010 Update
ACRP Northern California Chapter

March 8, 2010
Kaiser Foundation Research Institute
FDA Final Guidance for Investigator Responsibilities

April 23, 2010
Advanced Vendor Management Workshop: Quality and Compliance!
ACRP Global Conference
Tampa, FLA

April 24, 2010
FDA Final Guidance-Investigators: Medically Qualified Staff
ACRP Global Conference
Tampa, FLA

April 26, 2010
FDA and OHRP Training Requirements: 2010 Update
ACRP Global Conference
Tampa, FLA

June 13, 2010
Advanced Vendor Management Workshop: Quality and Compliance!
DIA Annual Meeting
Washington, DC

June 16, 2010
Responding to FDA/OHRP Training Requirements for Investigators and Institutions
DIA Annual Meeting
Washington, DC

June 16, 2010
Quality and Performance in Clinical Research: Establishing a Quality Management System for Success!
DIA Annual Meeting
Washington, DC

September - December, 2010
Good Clinical Practices Course
University of California, Berkeley
Quality and Compliance Certificate Program

September 16, 2010
FDA Guidance Document: Protecting the Rights, Safety and Welfare of Study Subjects – Supervisory Responsibilities of Investigators, National Human Subject Protections Conferences
Office of Human Research Protections (OHRP)

October, 2009
Changing Landscape of FDA Expectations of Investigators: An Overview of the FDA Final Guidance of 2009
RAPS Annual Conference
San Jose, CA

October 17, 2010
SOPs 101: A Primer for Institutions and Investigators
Society of Research Administrators Global Conference

October 23, 2010
SOP Writing 101: A Primer for Investigators and Institutions Society of Research Administrators Annual Meeting
Chicago, IL

October, 2010
Workshop: Current FDA and OHRP Requirements: What every Research Administrator MUST KNOW!
Society of Research Administrators Global Conference

December, 2010
Invited Faculty, Dartmouth Medical Center
FDA Guidance Document: Protecting the Rights, Safety and Welfare of Study Subjects – Supervisory Responsibilities of Investigators

December, 2010
Invited Faculty, University of Rochester Medical Center – Human Subjects Protection Office
FDA Guidance Document: Protecting the Rights, Safety and Welfare of Study Subjects – Supervisory Responsibilities of Investigators

2009 Engagements

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January, 2009
Project Management and Outsourcing for Clinical Research
UC Berkeley
Berkeley, CA

February, 2009
ACRP Clinical Research Coordinator Exam Review Course –
Stanford-SPCTRM
Palo Alto, CA

April, 2009
ACRP Global Conference
Denver Colorado
Pre-Conference Workshop: Improving Presentation Skills in Clinical Research:
Panel Discussion: FDA Draft Guidance – Protecting the Rights, Safety and Welfare of Study Subjects- Supervisory Responsibilities of Investigators

April, 2009
Clinical Project Management
UC Santa Cruz
Cupertino, CA

June 12, 2009
Keynote Speaker, University of California Berkeley
Graduation Ceremonies
Clinical Research and Conduct Management Certificate Program

July 17, 2009
ACRP Clinical Research Associate Exam Review Course
San Diego, CA

September 18, 2009
ACRP Northeastern Ohio Chapter Annual Conference
Quality Systems Management for Investigational Sites
Cleveland, Ohio

September 26, 2009
Project Management and Outsourcing for Clinical Research
UC Berkeley
Berkeley, CA

October 18, 2009
SOP Writing 101: A Primer for Institutions and Investigators
Society of Research Administrators International Conference
Seattle, WA

November, 2009
Clinical Project Management
UC Santa Cruz
Cupertino, CA

 
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Random Testimonial

"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