Quality Audits in the (Bio)Pharmaceutical and Device Industry
External and Internal Quality Audits in GMP manufacturing including the (bio)pharmaceutical and medical device industries are global regulatory compliance tools to ensure the safety and effectiveness of drugs, vaccines, other biological products, and devices. The course includes an overview of regulatory requirements, the different types of audits, and how to prepare for, conduct, and follow up on an audit. Special attention will be given to the internal audit which is a company’s most important managerial tool for monitoring the quality of processes and products. Internal audits, when effectively implemented, are critical to the identification of weaknesses and the continual improvement of the Quality System.