Most agencies worldwide that regulate the healthcare industry, including the European Medicines Agency (EMA), Japanese Ministry of Health, Labour and Welfare (MHLW), Organization for Economic Cooperation and Development (OECD), US Food and Drug Administration (FDA), and recognized international quality standards organizations, such as the International Organization for Standardization (ISO), require manufacturers to conduct internal audits of their quality management systems 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 and provides the opportunity to correct or prevent these problems. It can also help provide the 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 will provide fundamental good quality auditing practices knowledge and skills. It is intended to review the background on auditing practice and the evolution of the requirements from a regulatory point of view, and present an overview of the applicable regulations.
Learning Objectives
Upon completion of this course, students should be able to:
- Interpret the latest regulatory expectations for compliance with drug regulations in the US, Europe, Canada, Australia and Japan
- Analyze global government expectations when conducting investigations
- Apply auditing techniques, useful tips and methods employed by skilled auditors to get at the underlying issues or to assure compliance within their organizations
Target Audience
This course is designed for quality and regulatory professionals with little or no previous auditing experience, as well as individuals needing to broaden their knowledge of this topic.