In the field of industrial biotechnology, Good Documentation Practices (GDP or GDocP to distinguish it from Good Distribution Practices) are crucial to ensure that all documentation is accurate, complete, easily retrievable, and reliable. Proper documentation supports regulatory compliance, ensures product quality, and provides a reliable record of manufacturing processes. Companies must develop quality systems employing ALCOA+ procedures to ensure records are created, managed, and retained as required, to assure an effective and auditable pharmaceutical quality system,. By adhering to these guidelines, companies can ensure that their data practices meet regulatory standards and support their market applications and quality assessments.

The course will cover fundamental GDocP concepts and illustrate best practices and vetted classroom activities that will assist educators to easily introduce data integrity principles into their classrooms to prepare students for future success in bioscience industry careers.

Learning Objectives

• Learn why Good Documentation Practices are essential to a Quality Management System
• Understand the significance of Good Documentation Practices for biotechnology and biomedical students entering the biopharmaceutical industry, including how GDocP ensures data integrity and regulatory compliance.
• Apply the ALCOA system (Attributable, Legible, Contemporaneous, Original, and Accurate) to Good Documentation Practices in research and industry settings.
• Differentiate between various types of controlled documents such as Standard Operating Procedures, Work Instructions, Batch Records, Test Records, and key documents applicable to biomedical and biotech processes.
• Learn the correct procedures for completing various documentation types, focusing on the distinction between correct and incorrect record-keeping.
• Understand the requirements of 21 CFR 11, specifically regarding electronic records and electronic signatures.
• Bring GDocP concepts to life into the classroom through various activities and best practice guidelines.