Risk-Based Clinical Quality Assurance


Risk-Based Clinical Quality Assurance:
Train Your Auditors Like the FDA Does

Bethesda, MD • June 18-19, 2014


Meet Your Expert Instructor


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, biologic and medical device firms in the US and Europe.

Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and is knowledgeable in the details of compliance with all US 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, Ms. Sceppa has been a faculty member of the Parenteral Drug Association’s (PDA) Training and Research Institute (PDA-TRI) in Baltimore, MD.

What Previous Attendees Have to Say

 “Michelle was extremely knowledgeable and open to discussion and questions.”
            Nancy Watts, Quality Specialist, Compliance Insight

 “The working sessions were great. I liked hearing about Michelle’s experiences. I also like the ability to ask questions throughout the workshop.”
            Lisa Wethington, Consultant, QA, Eli Lilly