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)
Home • Quality Solutions • SOP Writing
Standard Operating Procedure (SOP) Writing

SOP WritingSOP development and writing services, as well as design and implementation of your controlled document's systems.

 

  • Organizational SOP on SOPs
  • SOP Writing
  • Process flow mapping/charts/diagrams
  • Document edits/revisions
  • Word processing
  • Document control, change control
  • Document filing and archiving procedures
  • Research (internal, external sources)
  • SOP Committee (lead, contribute)
  • SOP Committee Charter (develop, revise, update)
  • SOP Committe Meetings/Team Meetings (lead, facilitate, contribute)
  • Meetings with your staff or agents

We also offer a 3-day workshop on SOP Writing.  Read more about it here.

 

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Random Testimonial

"This course was extremely helpful. I have experience with a joint FDA and EMA inspection and Clinical Oversight was a critical factor with the CRO. Liz is knowledgeable on this topic and provided good examples in the course. The course handouts were very good and will be useful to take back to my company and use to discuss with the clinical group."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Ron Lang, Senior Director, Quality Assurance, Valeant Pharmaceuticals