Regulation of the Pharmaceutical Industry

Explore how the pharmaceutical industry is regulated across major global drug markets, focusing on key regulatory authorities, the processes for new drug approval in the US and EU, and the various types of FDA inspections. The module explains the critical roles of regulatory bodies in ensuring compliance with Good Manufacturing Practices (GMP), outlines the consequences of non-compliance, and emphasizes the importance of individual employee responsibility during regulatory inspections.

Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.

Duration: 30 Mins
Grade: Core Library

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SKU: PGB-1102-SPL02-EN Categories: API Manufacturing, Finished Dose Manufacturing, GCP, GMP Tag: PGB

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Description

Learning Objectives:

Explain why the pharmaceutical industry is regulated.
List the main regulatory bodies within the global pharmaceutical industry.
Define the responsibilities of regulatory authorities.
Explain how the new drug approval process works in both the US and the EU.
List the three main types of FDA inspection.
Describe the purpose of each type of FDA inspection.
Explain the difference between a 483 report and a Warning Letter.
List three potential consequences of failing to correct violations detailed in an FDA Warning Letter.

Learner Benefits:

Comprehensive Understanding of Industry Regulation: Gain a thorough overview of the reasons behind the stringent regulation of the pharmaceutical industry and the roles of major global regulatory bodies in maintaining public safety.

Insight into Drug Approval Processes: Learn the steps and requirements involved in obtaining new drug approval from both the US FDA and the European Medicines Agency, including the essential documentation and criteria for market entry.

Detailed Knowledge of FDA Inspections: Understand the differences between pre-approval, post-approval, and GMP systems inspections, and learn how these inspections are conducted to ensure ongoing compliance with GMP standards.

Preparedness for Regulatory Inspections: Equip yourself with the knowledge of how employees should conduct themselves during FDA inspections and understand how GMP compliance affects the entire organization.

Awareness of Inspection Outcomes and Consequences: Learn about the implications of FDA 483 reports, Warning Letters, and the severe consequences of non-compliance, such as market bans and product recalls, reinforcing the importance of maintaining GMP standards.

Module Features:

Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen