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.

Engagements 2010

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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 InstitutionsSociety of Research Administrators Annual Meeting
Chicago, IL

Engagements 2009

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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

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 and training consulting firm based in the San Francisco, CA area. QD-QTS is the only one of its kind providing internal quality systems development and deployment support for sponsor - CRO organizations ranging in the 'start-up company' phase to large - global organizations, as well as, investigational sites (academic institutions, hospital - systems compliance offices, VAMC, site networks) requesting system-wide audits and infrastructure expansion to support local/global clinical trials, as well as, providing regulatory agency inspection readiness program support, auditing services, post-inspection (internal/external audits) CAPA support, SOPs/standards and training expertise and services. Our approach is based on sound quality management principles, regulatory agency and industry driven requirements. Medical Symbol


Our goal is to provide the operational, quality and compliance expertise to support the development of your organization's quality systems infrastructure (policies, standard operating procedures (SOPs), standards, systems and processes) that supports both quality in clinical research and regulatory agency inspection readiness thereby equipping your organization for both organizational effectiveness and growth.

The cornerstone to the implementation of your quality systems is effective, timely and relevant communication and training to your personnel; our team also designs and delivers these services for your organization.

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.

 
 
SOP Writing - 3 Day Workshop
SOP Writing Logo

This 3 day, interactive Standard Operating Procedures (SOP) Writing Course for clinical research is designed for the novice or experienced clinical research professional who is required to oversee, administer, manage, write, implement or evaluate procedures – SOPs - for investigational sites, institutions or Institutional Review Boards (IRBs). Both the US Food and Drug Administration (FDA) and Office of Human Research Protection (OHRP), have documented their expectations for SOPs to be in place and adhered to.
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GCP Training

starWe provide public and on-site specialized training courses for drugs & biologics, and medical devices.
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Introduction to Drug Development
Mortar & Pestle

This course provides an overview of the development of drugs from discovery to commercialization. The role of the US Food and Drug Administration throughout the drug development lifecycle is discussed in conjunction with their relationship with the sponsor company to bring safe and effective products to market.
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Clinical Operations Skills Curriculum Courses

Clinical Skills Courses LogoThese clinical operations skill-based courses are provided on-site and provide attendees with the regulatory rationale for the activity as well as the specific job skill, in the classroom. For example, our Clinical Site Monitoring Course, an intensive course, provides case studies and scenarios/simulations for each type of monitoring visit, inclusive of investigational product accountability (pill bottles, accountability logs), subject case histories, case report forms, site regulatory binders etc.

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Random Testimonial

"GCPs are the foundation of our work. This was a good course and great refresher for me. Liz is an engaging trainer"

Erin Herman,
Sr CRA, Tercica
Good Clinical Practices Course ( 3 day course)