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)
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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 provided a very good presentation of GCP. Exercises kept everyone engaged and alert"
Virginia Baker
CRA, Tercica
Good Clinical Practices Course ( 3 day course)