Good Documentation Practices

Mon August 09, 2021

Course Description

Good Documentation Practices (GDP) are regulatory guidelines that help drug manufacturing companies maintain a system of controlled documents. GDPs ensure proper recording, reporting, and archiving of everything involved in the manufacturing processes. These practices are critical for capturing information used to support compliance with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP). Educators will learn strategies and standards of GDP, as well as the role of documentation in interdepartmental communication and the lifecycle of a drug product. The course will also review best practices and classroom activities for applying fundamentals of GDP into the classroom, to provide students practice and awareness of a critical industry skill.

Learning Outcomes

• Understand the importance of Good Documentation Practices (GDP) and the purpose of controlled documents in the drug manufacturing process
• Identify differences between various controlled documents required to maintain regulatory compliance with current Good Manufacturing Practices (cGMP)
• Recognize how to accurately complete cGMP-compliant paper records
• Appreciate how GDP relates to departmental roles and company culture within the (bio)pharmaceutical industry
• Communicate career opportunities within the (bio)pharmaceutical industry
• Apply enhanced understanding of Good Documentation Practices (GDP) to the classroom through various activities and best practices