Meet our President

Liz Wool

Call Us: 650.616.4199

Office hours: 8 am to 5 pm PST.

Upcoming Events

July

View Full Calendar

Engagements 2009

star

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Panel Discussion: FDA Draft Guidance – Protecting the Rights, Safety and Welfare of Study Subjects- Supervisory Responsibilities of Investigators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)
Home

--- Time is of the essence ---
precise timing of performance is critical in product development

DNA

QD-Quality and Training Solutions, Inc.™  is a full service clinical quality systems and training consulting firm whereby we provide internal quality systems development and deployment support for organizations in the 'start-up company - virtual company' phase to medium sized organizations requesting system-wide audits and infrastructure expansion to support global clinical trials.  In support of your clinical development program, we provide a comprehensive regulatory agency inspection readiness program inclusive of auditing services, post-inspection CAPA support (internal and external audits), as well as Standard Operating Procedures (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.
Read more...
 
GCP Training

starWe provide public and on-site specialized training courses for drugs & biologics, and medical devices.
Read more...
 
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.
Read more...
 
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.

Read more...
 
everyday, quality and training solutions
Username: 
Password: 
MORE
 

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)
October, 2007