GCP Qualification Audits: Choosing Quality Contractors and Sites

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GCP Qualification Audits
Choosing Quality Contractors and Sites

“Contractors are to be considered an extension of your company,” Michelle Sceppa — a GCP consultant with more than 25 years of experience in quality assurance and regulatory compliance — tells sponsors.  “The regulatory requirements that apply to your company and products must apply to them as well.”

There are a lot of moving parts to a clinical trial — CROs, sites, laboratories — and all of them are subject to the FDA’s Good Clinical Practices standards.  But only the trial sponsor bears full responsibility for GCP compliance.

In GCP Qualification Audits, Ms. Sceppa lays out her approach to evaluating and selecting the best, most compliant and highest quality contractors to give your trial the best shot at success.

The report begins by outlining the regulatory requirements for qualifying contractors. And follows up with instructions for auditing the three main players — CROs, clinical sites and central testing labs. The report also explains how to apply risk management principles to selecting contractors.

You will learn:

  • How to qualify CROs
  • How to work with CROs to audit sites and labs
  • How to use a risk-based approach to qualification audits
  • What FDA and ICH guidances apply to GCP qualification
  • What documentation to collect and how to create vendor files
  • How to develop and use audit checklists
  • How to assess a CROs overall effectiveness in conducting a study

Order your copy of GCP Qualification Audits: Choosing Quality Contractors and Sites and learn what to look for in a compatible CRO and how to work with that partner to evaluate the trial sites and central testing laboratories that will do the hands-on work.

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PDF Edition


Available Format

PDF Edition — $397

Who Will Benefit

  • Quality assurance manager
  • Regulatory affairs
  • Principal investigators
  • Site managers

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