Meet our President

Liz Wool
Liz Wool, CCRA. CMT
President & CEO
QD-Quality and Training Solutions, Inc.

Former Member, Board of Trustees
Association of Clinical Research Professionals (ACRP)

Call Us:
615.979.2376

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

Certified SBA Woman-Owned Small Business

MCC Member

NSA Member

Engagements 2015

star

March 2015
Workshop: Moving Beyond Basic GCP Training to Education Methods that Support Performance and Quality

April, 2015
Facilitator: Exploratory Learning Session - Emerging Quality Trends from Regulatory Authorities: Qualifications And Training of Staff

April 2015
Presentation: Quality by Design, Simplified and Attainable
ACRP Annual Conference

May, 2015
Presentation: Hidden Risks with Risk-Based Monitoring
ACRP Atlanta Chapter

June 2015
Presentation: Re-Engineering the RFP and Bid Defense Meeting Manage Risk and Quality
Clinical Trials Oversight Summit

June 2015
Faculty: Quality by Design in Clinical Research: Is This Only for the Protocol?
Clinical Trials Oversight Summit

June 2015
Workshop-Tutorial: Quality Oversight of CROs-Clinical Vendors
DIA Annual Meeting

June 2015
Workshop: Quality by Design in Clinical Research: Is This Only for the Protocol?

October 2015
Invited Speaker: Human Subject's Protection Conference
Sponsored by Cincinnati Children's Medical Center

October 2015
Course Faculty: Fundamentals of Clinical Research
ACRP

2015
Faculty: Establishing a Risk Management Framework for Clinical Trials and Oversight Webinar

2015
Faculty: Managing Risks in Outsourced Clinical Trials: Practical Approaches and Tools

2015
Presentation: Engineering the RFP and Bid Defense Meeting Manage Risk and Quality

QD-Quality & Training Solutions Logo
compliance - quality - performance: Time is of the essence (TM)
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--- Time is of the essence ---
precise timing of performance is critical in product development

DNA

QD-Quality and Training Solutions, Inc.™ (QD-QTS) is a full-service clinical quality systems, auditing, and training consulting firm based in the Nashville, TN area. Our approach is based on sound quality management principles, regulatory agency and industry driven requirements.

Our goal is to provide the operational, quality and compliance expertise to support the development of your organization's quality systems and training infrastructure that supports both quality in clinical research and regulatory agency inspection readiness thereby equipping your organization for both organizational effectiveness and growth.

Clients:

  • Sponsors
  • CROs-Vendors
  • Investigators
  • Academic Medical Centers
  • Investigational Sites, Site Management Organizations
  • Veteran Affairs Medical Centers and Clinics
  • Military Medical Centers and Clinics

Quality Systems Services

  • Gap Analysis and Reports
  • Governance Structure
  • Infrastructure
  • Policies
  • Standard Operating Procedures (SOPs)
  • Risk Management - Quality Risk Management
  • Indicators and Metrics: Performance, Quality, Risk
  • Employee Training Plans
  • Training Standards
  • Employee Training Files
  • Personnel Training: materials development, delivery of training
  • On-going Monitoring Methods
  • Continuous Process Improvement

CRO-Vendor Oversight Services

  • Gap Analysis and Reports
  • Governance Structure
  • Infrastructure
  • Metrics: Performance-Quality-Risk Indicators
  • Reports, Scorecards, Dashboards
  • SOPs, Forms, Templates
  • CRO-Vendor Management Plan Templates
  • CRO-Vendor Quality Management Plan Templates
  • Personnel Training: materials development, delivery of training




Auditing Services

  • Due diligence/qualification audits of CROs-Vendors
  • Investigator site audits
  • Central IRBs
  • Sponsor audits
  • Regulatory Authority Inspection Readiness

CAPA Services

  • Lead/contribute/develop audit CAPA responses
  • Develop SOPs and associated documentation
  • Develop management review reports, scorecards and dashboards
  • Support includes 7 days/week to meet CAPA goals

Training Services

(contact us for our comprehensive course listing)

In summary, QD-Quality and Training Solutions, Inc.™ partners with you to ensure that your organization will be self-sufficient in all areas of business performance and global regulatory inspection readiness.

 
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Random Testimonial

"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)