Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers

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Now you can learn how to FDA-proof your CQA audits … eliminate costly mistakes … and avoid FDA warning letters that say:

“You failed to obtain and document that valid informed consent was obtained for each of the subjects enrolled in the study as required by stated regulations.”

Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies.

But with millions of dollars and decades of research at stake, study staffers aren’t always eager to cooperate.

That’s why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function, including how to:

  • Understand the basic principles of GCPs and international regulations
  • Determine if GCPs are being followed and what needs to be documented
  • Balance the relationships — QA, clinical and the CRO — in the ever-changing economy where clinical study outsourcing is common
  • Define responsibilities with outsourced clinical trials and the role communication plays in maintaining compliance
  • Select sites to be audited — strategies for deciding who to audit
  • Audit a CRO or central laboratory — who and how do you audit these specialized providers
  • Manage the audits (logistics, time, etc.) — understanding the management of the audit is essential to assuring completion of everything that needs to be done
  • Conduct the audits — what do you do and what interviewing skills are needed
  • Compose the site visit audit report — writing it is sometimes the hardest thing to accomplish
  • Evaluate the audit findings and implement corrective actions — once the report is written the audit is not over
  • Master FDA inspections and avoid the top five GCP violations

  • Clinical quality assurance managers and auditors
  • Clinical site directors
  • Clinical research associates/coordinators
  • Regulatory affairs
  • IRB administrators

Michelle Sceppa, principal and founder of MSceppa Consulting, has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologics and medical device firms in the U.S. and Europe.

Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and has knowledge in the details of compliance with all U.S. federal regulations, including: good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP) for drugs, biologics and medical devices.

Ms. Sceppa is also certified in the Q7A regulations for the manufacture of active pharmaceutical ingredients. Since 2002, she has been a faculty member of the Parenteral Drug Association’s (PDA) Training and Research Institute (PDA-TRI) in Baltimore, MD.

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