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Founded in 1998 in Dublin, Ireland, Skillpad's team of industry-experienced Subject Matter Experts and Consultants believes Pharma, Biopharma, and Life Science Industry manufacturing companies can achieve production excellence with improved performance, productivity & compliance, as well as reduced losses & down-time, if they have KNOWLEDGE CONSISTENCY in all critical areas of manufacturing operations.

With 25 years in business, and offices in Europe, the USA and Canada, Skillpad has helped customers all over the world with Life Science Industry Knowledge challenges. We are fully dedicated to the idea that Knowledge Consistency is more achievable than ever using the latest technology and advanced knowledge transfer and management tools.

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Regulation of the Pharmaceutical Industry

Who regulates the pharmaceutical industry, how new drugs are approved, types of regulatory inspections, and the role of employees in 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

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

Description

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.

Module Features:

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