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:
650.616.4199 (California, USA office)
615.732.6035 (Tennessee, USA office)

Office hours: 8:30 am to 5 pm (local time).

MCC Member

Engagements 2012

star

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

QD-Quality & Training Solutions Logo
compliance - quality - performance: Time is of the essence (TM)
Home

--- 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 San Francisco, CA 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
  • CRO-Vendor Quality Agreements
  • 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.
 
everyday, quality and training solutions
Username: 
Password: 
MORE
 

Random Testimonial

"This course was excellent."

Good Clinical Practice for Medical Device IDE Trials
Preety Grewal, CRA II, Arthrocare