Introduction to Quality Documents and Technical Writing

Quality documents in the pharmaceutical industry are critical for ensuring that pharmaceutical products are manufactured in a consistent, safe, and effective manner. They are used to document all aspects of the manufacturing process, from raw material procurement to the final product release. These quality documents are essential for ensuring that pharmaceutical products are manufactured in compliance with regulatory requirements and meet the highest standards of quality and safety. They must be controlled, approved, and maintained in a manner consistent with Good Documentation Practices (GDP) and other applicable regulatory requirements.

This course is designed based on case studies and practical projects and aims to cover the essential elements of developing Standard Operating Procedures (SOP), process flowcharts, audit responses, change controls, stability documents, and deviations.

At the end of this course, students will be able to Write and review various quality documents such as SOPs, change control forms, deviation reports, and stability and audit reports in compliance with GDP.

Learning Points:

• Introduction to Technical Writing and Scientific Communications
• Standard Operating Procedures
• Flowcharts
• Deviation Report Writing
• Change Control Report Writing
• Stability Writing
• Audit Response Writing