Pharmaceuticals: Compliance & Audits

This course provides knowledge of fundamental, high-quality auditing practices and skills.

Many agencies around the world are tasked with regulating the healthcare product industry within their respective countries. They include the US Food and Drug Administration (FDA); European Medicines Agency (EMA); Health Canada (HC); Japan’s 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 important roles. 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, high-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.

At a Glance

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.

Learning Level: Basic, Intermediate

Total Length of Course: 5 Hours

RAC Points: 5

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Interpret current regulatory pharmaceutical compliance expectations in the US, EU, Canada, Australia and Japan.

Analyze on a global level the government expectations when conducting investigations.

Apply auditing techniques, tips and methods employed by skilled auditors to address underlying issues and assure compliance within their organizations.

Lesson Titles

Lesson 1: Pharmaceutical Drug Compliance

Lesson 2: Pharmaceutical Drug Audits

Lesson 3: Auditing Techniques and Tools

This course is also included in: