PFT911 - Pharmaceutical Quality Assurance Basics

This course focuses on the concept of quality assurance and the contributions of quality assurance in a pharmaceutical organization. It takes a snapshot examination of common quality applications, tools, processes, and systems relevant to the pharmaceutical industry. Topics covered include: foundations of quality, basic statistical concepts and applications, document systems, SOPs, quality audit, validation, ISO standards, GMPs (FDA and HPFBI), product recall and complaints handling.

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