This course provides a basic understanding of Current Good Manufacturing Practices (CGMPs) and their impact on product quality and patient safety. The course covers a wide range of issues including why regulations were created and are enforced worldwide, how pharmaceutical companies ensure compliance with the regulations, reasons for making quality products, US and EU regulations, the consequences for failing to comply with any regulations and associated regulatory actions.

Learning Objectives

• Describe the CGMPs
• Describe why CGMPs exist
• Identify the parts of a Quality System
• Define quality and recognize the relationship with CGMPs
• Identify areas affected by CGMPs
• Define the guiding values of the CGMPs
• Identify the key points of the GMP subsections
• Distinguish between the different types of regulatory inspections

Target Audience

This is an introductory course designed for new pharmaceutical personnel interested in learning the basic GMP regulations and principles in the US and EU.

Instructors

Vince Mathews, Quality Assurance Consultant, Eli Lilly
Vince Mathews is a Quality Consultant in QA for Global Development Operations at Eli Lilly and Company. In his current role, he is involved in establishing corporate quality requirements for the development and manufacture of investigational new drugs and provides internal direction on corporate quality issues. Matthews previously worked in the commercial manufacturing areas—including positions in Corporate Quality Assurance for and in Quality Assurance and the QC Laboratory. Matthews earned an MS, analytical chemistry, at Purdue University.

Luma Izzy, Sr QA Rep, Eli Lilly and Company
Luma Izzy is a Senior QA Representative in the Corporate QA group supporting Global Development Operations at Eli Lilly and Company. She is responsible for establishing quality standards to ensure compliance with CGMP regulations, consulting with manufacturing sites, monitoring and influencing the external environment, providing internal training and participating in audits. Izzy previously worked in QA at a biotechnology production facility, responsible for the implementation and execution of quality standards. Her work there included batch disposition, review of equipment qualification packages, assessment of changes and deviations, and performing site self-assessments. Izzy has a Bachelor in Pharmacy and Masters in Pharmaceutical Chemistry from Baghdad University, School of Pharmacy.