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Quality Insider

Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers

Nov. 7–8, 2011, in Boston

Published: Wednesday, October 5, 2011 - 13:12

(FDAnews: Falls Church, VA) -- The interactive workshop, Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers, scheduled for Nov. 7–8, 2011, at the Radisson Hotel in Boston, is presented by MSceppa Consulting, provider of quality assurance consulting and auditing for pharmaceutical and biotechnology industries, and FDAnews, provider of domestic and international regulatory, legislative, and business news and information for industries regulated by the U.S. Food and Drug Administration (FDA).

Now you can learn how to FDA-proof your clinical quality assurance (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.”

What you will learn

Clinical trial sponsors rely on 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, which include how to:
• Understand the basic principles of good clinical practices (GCPs) and international regulations
• Determine if GCPs are being followed and what needs to be documented
• Balance the relationships—quality assurance (QA), clinical, and the clinical research organization—in an 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 clinical research organization 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 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 implementing corrective actions—once the report is written, the audit is not over.
• Master FDA inspections and avoid the top five GCP violations

Who benefits?

The interactive workshop will benefit CQA managers and auditors, clinical site directors, clinical research associates/coordinators, regulatory affairs, and Institutional Review Board administrators.

Click here for the agenda.

Workshop instructor

Michelle Sceppa, instructor of the workshop, 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, biologic, and medical device firms in the United States and Europe. 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. She 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 Training and Research Institute in Baltimore.


There are four easy ways to register:

• Online at www.fdanews.com/ClinicalQuality
• Calling (888) 838–5578 or (703) 538–7600
• Fax to (703) 538–7676
• Mail to FDAnews, 300 N. Washington St., Ste. 200, Falls Church, VA 22046–3431


About The Author

FDAnews’s picture


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.