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Good Manufacturing Practice (GMP) [4.0 RAC]

4.0 RAC Credits Member: $465.00 Nonmember: $640.00
Good Manufacturing Practice (GMP) [4.0 RAC]
Good Manufacturing Practice (GMP) is a term that is recognized worldwide for the control and management of manufacturing and quality control of active pharmaceutical ingredients, foods, pharmaceutical products and medical devices. GMP regulations and guidance are designed to ensure that products are consistently produced and controlled to quality standards. Most countries have promulgated regulations and guidelines defining GMPs and require that pharmaceutical manufacturers comply with their own GMP guidelines.

This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety. It 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.

At a Glance
  • Target Audience: This course is designed for regulatory professionals interested in learning the basic GMP regulations and principles for the US and EU.
  • Learning Level: Basic
  • Total Length of Course: 4 Hours
  • RAC Points: 4

Learning Objectives

Upon completion of this course, participants should be able to:
  • Describe CGMPs and why they exist
  • Define quality and state the reasons it is important
  • Identify the parts of a quality system
  • Discuss the role of the quality unit
  • Define the guiding values of the CGMPs
  • Identify and explain significant events that prompted GMP regulation
  • Identify key sections of the GMP regulations for the US and EU
  • Distinguish between different types of inspection and enforcement activities

Lesson Titles
  • Lesson 1: History of Regulations
  • Lesson 2: Pharmaceutical GMPs
  • Lesson 3: Quality and the Quality Organization
  • Lesson 4: Materials System
  • Lesson 5: Laboratory System
  • Lesson 6: Facilities, Utilities, Equipment and Maintenance System (FUEM)
  • Lesson 7: Production System
  • Lesson 8: Packaging Systems

Enrollment Period: 12 months
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