778111 - Teaching Good Documentation Practices as a Workplace Skill
Course Description
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.
This course is designed for secondary and post-secondary bioscience teachers who want to equip their biotechnology and biomedical students with the essential skills needed to navigate and excel in the biopharmaceutical sector. Participants will learn to implement best practices for documentation etiquette in this industry, ensuring that future professionals can readily apply these principles in real-world scenarios.
Course Fee
$250 per participant
Duration
Participants have 90 days following enrollment in which to complete the course.
Course Access
To access your course after enrollment, please click the link below.
Click the blue “Log in to Continuing Education” button and enter your login credentials (be sure to use the same third-party credentials you entered during enrollment). You should then see your course on the UF e-Learning dashboard or by clicking Courses>All Courses.
Please note, it is common practice to enroll in multiple courses or sections in order to access all online content relevant to your program. However, you will only create one UF account once (during your first enrollment).
Contact Us
If you have questions or need assistance, please contact Jenny Hughes
Phone: 386.518.2118
Email: biotilitypd@research.ufl.edu
Learner Outcomes
- 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.