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

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

MCC Member

Engagements 2011

star

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

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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 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.
 
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Random Testimonial

"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)