Overview
Overview
This course builds on part 1 of the cGMP – Quality Systems course and is intended to provide learners with advanced quality assurance principles and practical applications of cGMP in the pharmaceutical industry. Learners will gain significant knowledge to implement quality management processes such as change control, complaint handling, recall program, investigations, validation, and stability to maintain compliance with cGMP. Also, issues surrounding the importance of accurate documentation and quality systems will be discussed in detail.
At the end of this course, students will be able to design and implement record-keeping procedures in accordance with cGMP guidelines, respond to quality complaints, and implement recall protocol. Students will have the skill to identify gaps and recommend remedial action to improve compliance and evaluate a simple pharmaceutical validation plan.
Learning Points:
At the end of this course, students will be able to design and implement record-keeping procedures in accordance with cGMP guidelines, respond to quality complaints, and implement recall protocol. Students will have the skill to identify gaps and recommend remedial action to improve compliance and evaluate a simple pharmaceutical validation plan.
Learning Points:
- Pharmaceutical Records and Reports
- Returned Drug Products Process
- Complaints Handling and Recalls
- Investigations (OOS), Root Cause Analysis, CAPAs
- Change Controls
- Validation – methods and processes
- Stability Program of Drug Products
OUR STUDENTS WORK AT
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