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Good Documentation Practices to Support FDA Computer System Validation

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Deadline: April 04, 2017 | Date: April 04, 2017

Venue/Country: Online

Updated: 2017-03-09 16:13:30 (GMT+9)

Call For Papers - CFP

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.

Why Should You Attend

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that the cost of building and managing a computer system validation program will be minimized.

It is critical to understand both the set of deliverables/ documents that must be generated and maintained for FDA compliance. It is also critical to understand the best practices to meet compliance when preparing, approving and maintaining critical validation documentation.

This webinar will provide a complete understanding of the Computer System Validation deliverables required and the best practices for documenting and maintaining these to meet FDA compliance.

Areas Covered in this Webinar

Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs)

Good Clinical Practices (GCPs)

Good Documentation Practices (GDPs)

Computer System Validation (CSV)

The System Development Life Cycle Methodology (SDLC)

Validation Planning, Execution and Documentation

21 CFR Part 11 (FDA Guidance for Electronic Records and Electronic Signatures)

Cost vs. Compliance

Documentation Storage and Retention

Industry Best Practices

Learning Objectives

To provide an understanding of Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs and GCPs) in relation to Computer System Validation

To explain the various Computer System Validation (CSV) documents that must be delivered to meet FDA compliance, and the System Development Life Cycle Development (SDLC) methodology that supports the process

To learn the requirements for documenting activities regulated by FDA, including computer system validation and general data recording, analysis and reporting

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, or “Good Documentation Practices (GDPs)"

Discuss the importance of training as it relates to good documentation practices to ensure FDA compliance

To explain how to handle systems that include Electronic Record (ER) and Electronic Signature (ES) capability, in order to meet FDA’s Guidance for ER/ES (21 CFR Part 11), learning how to apply GDPs to electronic records and signatures vs. paper records and “wet,” or ink signatures

To provide guidance as to managing the cost of validation efforts while meeting FDA compliance

To understand the best practices for documentation storage and retention

To learn about industry best practices and potential pitfalls

Who Will Benefit

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:


Medical Device






Third-Party companies that support those in the above industries

Colleges and Universities offering programs of study in Computer System Validation and Regulatory Affairs/Matters related to FDA

Personnel in the following roles will benefit:

- Information Technology (IT) Analysts

- IT Developers

- IT Support Staff

- QC/QA Managers and Analysts

- Clinical Data Managers and Scientists

- Analytical Chemists

- Quality Managers, Chemists and Microbiologists

- Compliance Managers and Auditors

- Lab Managers and Analysts

- Automation Analysts

- Computer System Validation Specialists

- GMP Training Specialists

- Business Stakeholders using Computer Systems regulated by FDA

- Regulatory Affairs Personnel

- Consultants in the Life Sciences and Tobacco Industries

- Interns working at the companies listed above

- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements

For More Info, Please Click below URL:

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