MSceppa Consulting-- Quality Assurance Consulting for the Pharmaceutical and Biotechnology Industries
Michelle Sceppa, Principal
Ms. Sceppa has 33 years of experience in Quality Assurance and Regulatory Compliance in the Pharmaceutical Industry.
Ms. Sceppa has implemented and managed Preclinical, Clinical, and Manufacturing Quality Assurance Programs for numerous clients. As the lead auditor, she has conducted and managed more than 500 internal and external vendor audits for Drug and Biologic firms in the US and Europe. Ms. Sceppa is the Principal in MSceppa Consulting. MSceppa Consulting is an establish Consulting firm and is in its 18th year in the Industry.
Ms. Sceppa is knowledgeable in the details of compliance with all U.S. Federal Regulations-Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) for Drugs, Biologics and Medical Devices. Ms. Sceppa is certified in the Q7A Regulations for the manufacture of Active Pharmaceutical Ingredients. Ms. Sceppa has extensive Training experience as a Course Instructor for FDA News and IPA Canada.