Biotility: Writing Controlled Documents in a CGMP Environment

Provides learners with the skills needed to create and manage controlled documents.

Organizations

LEARN MORE

INTERESTED? Demo Course

About this Course

This course provides learners with the skills needed to write controlled documents that minimize the risk of misinterpretation. It discusses change controls and the end-to-end document control process. The course emphasizes the importance of document integrity and control in maintaining regulatory compliance. It highlights the golden rule of controlled documents: if it is not documented, then it was not performed.

Language Availability: English

Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Faculty, Investigators, Research Administrators, Research Personnel, Students

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: $124.76

Demo Instructions

Course Content

Module One - Introduction

This module defines document control. It discusses the history of FDA laws and regulations governing controlled documents and their relationship to Current Good Manufacturing Practices (CGMP) and Good Documentation Practices (GDP).

Recommended Use: Required
ID (Language): 21625 (English)
Author(s): Marie Conzone, BS - Cadence Florida

Module Two – CGMP and GDP

The module defines Current Good Manufacturing Practices (CGMP) and Good Documentation Practices (GDP). It details the ALCOA principles and their relationship to GDP and data integrity.

Recommended Use: Required
ID (Language): 21526 (English)
Author(s): Marie Conzone, BS - Cadence Florida

Module Three - Departments

The module discusses departmental roles of Research and Development, Manufacturing, Quality Testing, and Quality Assurance. It focuses on departmental written procedures and their relationship to CGMP and GDP.

Recommended Use: Required
ID (Language): 21627 (English)
Author(s): Marie Conzone, BS - Cadence Florida

Module Four – Documentation

The module describes written procedures as the cornerstone of CGMP. It explains that GDP is an essential part of a Quality Management System (QMS) and Quality Assurance (QA). The module details how documentation and recordkeeping create easy to follow trails of a product, its components, equipment, and manufacturing processes.

Recommended Use: Required
ID (Language): 21628 (English)
Author(s): Marie Conzone, BS - Cadence Florida

FAQs

Who should take Biotility: Writing Controlled Documents in a CGMP Environment?

Learners who wish to gain a foundational knowledge of how to write and manage controlled documents should take Biotility: Writing Controlled Documents in a CGMP Environment. The course provides detailed descriptions of the role that Good Documentation Practices (GDP) play in the context of CGMP.

The course is ideal for Clinical Research Associates, Clinical Research Coordinators, Faculty, Investigators, Research Administrators, Research Sites, and Students.

How does Biotility: Writing Controlled Documents in a CGMP Environment complement other CITI Program courses?

Biotility: Writing Controlled Documents in a CGMP Environment imparts skills and knowledge that are a perfect complement to the Biotility: CGMP for Biopharmaceutical Drug Productsand Biotility: Good Documentation Practices (GDP)courses as GDP forms a critical component of CGMP. This course is also relevant to those learners taking our Clinical Research Associate (CRA), Clinical Research Coordinator (CRC) Foundations, and Biomedical Principal Investigator (PI) courses.

How long will the course take a learner to complete?

The time to complete the combined modules is approximately one hour.

Is the course eligible for continuing medical education credits?

The course does not currently have CE/CME credits available.

Learn More

Your Name(Required)

Email(Required)

Organization(Required)

How can we help you?(Required)

I am looking for technical support. Visit our Support Center.

I'd Like To Receive Emails From CITI Program

Sign me up for CITI Program’s weekly newsletter

Send A Message

This field is for validation purposes and should be left unchanged.