Biotility: Good Documentation Practices (GDP)

Strategies for implementing compliance with GDP, as well as standards and procedures for accurately completing Records required for current Good Manufacturing Practices (cGMP).

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About this Course

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.
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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

Demo Instructions


Course Content

Good Documentation Practices - Module 1

This module identifies the department responsibilities and the importance of GDP within an organization. It defines relative terms associated with GDP and explains how the ALCOA system applies.

Recommended Use: Required
ID (Language): 20640 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

Good Documentation Practices - Module 2

Learn by GDP are essential to a Quality Management System (QMS). This module identifies applications and differences among Procedures, Records, Forms, and other Controlled Documents. The module concludes with an overview of the basic principles of creating, reviewing, maintaining, and archiving Controlled Documents.

Recommended Use: Required
ID (Language): 20641 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

Good Documentation Practices - Module 3

This module reviews the requirements of U.S. FDA regulation 21 CFR 11 Electronic Records: Electronic Signatures. It covers the role of the Document Control Department and how Controlled Documents are maintained. Learners will be presented with examples of Controlled Documents and their applications within and among company departments.

Recommended Use: Required
ID (Language): 20642 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific

Good Documentation Practices - Module 4

Review the GDP proper techniques for capturing and editing contemporaneous information within specific types of Controlled Documents. This module presents the role of internal and external audits and considers the deviation and the document review process. It further explores consequences of noncompliance with GDP.

Recommended Use: Required
ID (Language): 20643 (English)
Author(s): Harry W. Rambo, Jr, AS - Thermo Fisher Scientific


FAQs

Who should take this Good Documentation Practices course?

The Biotility: Good Documentation Practices course is tailored to biotech industry service providers and personnel involved in the manufacture and/or testing of (bio)pharmaceutical drug products. This includes, but is not limited to:

  • Authors, reviewers, and auditors of documents within FDA-regulated industries
  • Associates and Managers working in Regulatory Affairs
  • Associates working in Document Control
  • Technicians and Specialists working in Quality departments (Quality Assurance/Quality Control)
  • Personnel working in Production/Manufacturing
  • Personnel working in Research and Development

What are the advantages of taking this course?

This Biotility: Good Documentation Practices 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.

GDP are critical for compliance with current Good Manufacturing Practices (cGMP) regulations. 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.

How long will the course take to complete?

The Biotility: Good Documentation Practices course consists of four modules. Completion of all four modules, as well as the corresponding learning assessments should take 180 to 205 minutes.