Many agencies around the world are tasked with regulating the healthcare product industry within their respective countries, including: the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), Japanese Ministry of Health, Labour and Welfare (MHLW), Australia’s Therapeutic Goods Administration (TGA) and Medsafe in New Zealand. Additionally, the Organization for Economic Cooperation and Development (OECD) and recognized international quality standards organizations such as the International Organization for Standardization (ISO) play an important role. These agencies and organizations require manufacturers to conduct internal audits of their quality management systems (QMS) on a regular basis to ensure compliance with the appropriate standards and regulations. In addition, critical suppliers must be audited to ensure their systems and processes meet the appropriate standards and regulations.
An effective audit program identifies weaknesses in the quality system (QS) and provides the opportunity to correct or prevent these problems. Audits also can help provide a company with insight into areas that could be improved. Without an effective audit program, a company is at higher risk for nonconformances, regulatory actions, security breaches, poor product quality, loss of certification and registration, increased product liability risk and a suboptimal process improvement system.
This course provides knowledge of fundamental good quality auditing practices and skills. It is intended to provide background information on auditing practice and the evolution of the requirements from a regulatory point of view, with an overview of the applicable regulations.