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Good Documentation Practices to Support FDA Computer System Validation

Duration : 90 Minutes

Carolyn Troiano,

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. Du Read more

We will discuss the importance of applying industry best practices when documenting the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process).  Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.

This course will describe the best practices for documenting validation work, including "who" should be responsible for such tasks and "how" the documentation should be accomplished.  FDA guidelines are very specific in terms of how this is to be done.

In addition, we will touch on elements of electronic records and electronic signatures (ER/ES, or FDA 21 CFR Part 11).  Specific criteria must be met in order to consider such a signature as valid in the eyes of FDA regulators.

Course Objectives:

• Gain an understanding of GAMP® 5  computer system classifications
• Develop the ability to apply GAMP® 5  in classifying computer systems in your organization
• Understand the level of computer system validation required, based on the classification as determined using GAMP® 5
• Discuss the best practices necessary to ensure all systems are classified properly and validated appropriately
• Learn how to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP® 5
• Understand how to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validated
• Learn how to gain information about trends in validation, as industry progresses and new best practices emerge
• Understand the level of training required for the various GAMP® 5  computer system classifications, and the skills and expertise necessary to make the classification determination

Course Outline:

• Learn the requirements for documenting efforts related to systems governed by FDA
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures.
• Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable
• Learn how to prepare a procedure that will capture the best practices for FDA compliant documentation
• Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

NOTE: GAMP® is a registered trademark of ISPE. To learn more about GAMP®, visit

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : Good Documentation Practices to Support FDA Computer System Validation

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