Best Practices in Preparation for an FDA Computer System Audit

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Deadline: May 19, 2016 | Date: May 19, 2016

Venue/Country: Online, U.S.A

Updated: 2016-05-06 15:00:28 (GMT+9)

Call For Papers - CFP

The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state.

Why should you attend :

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience.

Applying best practices will ultimately result in minimizing the time and cost of regulatory audits, and the impact on operations and productivity. While there are many sources of information to help you develop a good validation program, this course will narrow down the most overall cost-effective approach that is tried and true.

It is not enough just to validate a computer system and defend your approach to regulatory agencies. You will also need to ensure that the data and information collected, analyzed and reported using the system can be defended effectively, as well. In this course, you will learn how to apply industry best practices to ensure that you and your system users and other stakeholders are fully prepared to defend your systems, data and information to regulatory agencies. At the same time, you will learn how to do this in the most cost-effective manner."

Areas Covered in the Session:

There are specific best practices to be followed that will ensure you are fully prepared to defend your program and prove that you have thoroughly validated your computer systems that are subject to regulatory scrutiny. Being prepared will ensure a much easier interaction with the regulatory agency and will minimize the time and cost of the audit. A company’s readiness may also minimize the risk of findings and citations by showing the auditors that you have done due diligence and are able to respond adequately to all questions and requests for information in a timely manner.

Who will benefit: (Titles)

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Clinical Data Managers and Scientists

Analytical Chemists

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.

Webinar includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of attendance