Overview of GMP and Quality Concepts in Pharmaceuticals and Biotechnology
This module covers the basics of Good Manufacturing Practice (GMP) including the importance of following personal hygiene and data integrity at pharmaceutical companies.
FREE
Course Overview
90+ Hours Training
- Historical global inspection data on errors and non-compliance
- Sources of typical GMP error
- Importance of root cause determination and introduction to the concept of corrective and preventive action (CAPA)
- Personal hygiene including hand washing procedures and its importance in assuring product quality and patient safety
- A short review on the 10 golden rules of GMP
- Quality standards required in premises, equipment, and instrumentation
- Data integrity and its importance in all aspects of drug manufacturing and quality testing
- Animation: ALCOA and ALCOA +
- Typical Do’s and Don’ts when recording data
- Gamification to ensure users are engaged for this long and thorough module
Course Curriculum
1 Subject
Overview of GMP and Quality Concepts in Pharmaceuticals and Biotechnology
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