Ms. Sceppa is a highly experienced, quality assurance professional with hard industrial experience in all aspects of compliance with the U.S. Food and Drug Regulations -- Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and current Good Manufacturing Practices (GMPs) for Drugs, Biologics, and Medical Devices.
Ms. Sceppa is a certified auditor under FDA/ICH Q7A and is broadly knowledgeable with the requirements of the FDA, EMEA, and all aspects of quality assurance and regulatory compliance. Ms. Sceppa is also as a certified lead auditor for the EN 46001 regulations. She is experienced in qualifying pre-clinical contract laboratories, initiating contract research organizations (CROs), contract manufacturers, and testing laboratories and is experienced in all phases of new drug/device development, from discovery to market launch, including post-marketing support. Ms. Sceppa is experienced in dealing with a host of relationships, including the U.S. FDA, EMEA and MHRA, and serving as the quality assurance liaison with other consultants and contractors.
Compliance Activities include:
• CRO Qualification
• Clinical Study Audits
• Internal File Audits
• GCP Testing Facilities
• Contract Manufacturers
• Internal Audits
• Toxicology Studies
• cGMP - Introduction and advanced
• GCP - Clinical Study Compliance
Other Compliance activities include:
• Clinical Documentation Review (protocols, Investigator Brochures)
• SOP Writing • CMC Review
• Batch Record Review
Her wide industrial experience includes the manufacture of cell culture produced and organically synthesized molecules, including tissue (skin) replacement, single-isomer chemistry, combination devices, and drugs.
Ms. Sceppa is an active member of the PDA (formerly Parenteral Drug Association) at both the national and local chapter levels, including board officer of the New England Chapter.