Good Documentation Practices (GDP) are critical for compliance with current Good Manufacturing Practices (cGMP) regulations and within organizations implementing a Controlled Document System. Good Documentation Practices are a crucial part of quality management, assessing risks, batch tracing, auditing, and recall procedures. Failure to comply with these regulations can lead to data integrity risks, security and safety risks, as well as cGMP audit failures. With an emphasis on maintaining a system of control, this course presents strategies, standards, and practices for accurately completing Controlled Documents in a cGMP work environment.
Additionally, the course covers how to implement ALCOA, an acronym for a method used to ensure information is properly collected, recorded, and stored. Examples of documents discussed include Standard Operating Procedures, Work Instructions, Batch and Test Records, Forms, and key Controlled Documents central to many types of processes. The course will also address requirements of U.S. Food and Drug Administration regulation 21 CFR 11, Electronic Records; Electronic Signatures.
This Biotility: Good Documentation Practices (GDP) course was developed by experienced industry professionals to ensure that personnel working with Controlled Documents are informed of GDP requirements, recognize the importance of GDP to their assigned role, and are aware of the consequences of non-compliance.
The Good Documentation Practices (GDP) course is tailored to biotech industry service providers and personnel involved in the manufacture and/or testing of (bio)pharmaceutical drug products.
Note: This Biotility at the University of Florida course is offered by CITI Program. See FAQs below for more information.
Language Availability: English
Suggested Audiences: Associates and managers working in regulatory affairs, Associates working in document control, Authors and reviewers as well as auditors of documents within FDA-regulated industries, Personnel working in production/manufacturing, Personnel working in research and development, Technicians and specialists working quality assurance and quality control
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $124.75 per person