As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate a Quality Assurance component into your company’s Quality System. This is pivotal to ensuring that clinical research activities are conducted in compliance to applicable regulations. Auditing is used to verify and validate compliance. Clinical Auditing can be a great tool for discovering issues and rectifying them in ongoing research projects. Rather than have regulatory agencies inspection finding your studies were not conducted properly or in compliance, an audit is the preferred alternative. How do you conduct an effective audit will be reviewed in this webinar which will include preparation, auditing, documentation and follow up. This webinar will then move onto how to audit using Good Clinical Practice (GCPs) as the framework within clinical research no matter where the audit takes place including investigative sites, sponsors, or CROs. Finally the webinar will close with some information on latest trends in Clinical Quality Assurance. Areas Covered in the Session : General principles for auditing Steps for preparing and completing an audit Framework of using Good Clinical Practices Use of Tools and Processes Trends in Quality Assurance Who Should Attend: CEO’s Contract VP’s Quality Departments Regulatory Affairs Departments IT Departments Contract Personnel GxP Personnel Consultants


$350 

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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
recording
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recor corp
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