IT Governance and Controls for FDA & SOX compliance: The single solution

If yours is an FDA regulated pharmaceutical manufacturing firm and you must comply with the Sarbanes-Oxley Act of 2002 (SOX) Section 404 controls for Information Technology (IT), then a natural question to ask is: can you combine the IT Controls required for SOX with the measures needed to meet FDA requirements for 21 CFR Part 11, network security, and IT validation? The answer is a qualified yes, you can combine them. The next question is: does it make sense to do it and if so, how? In this seminar I show you how an IT control solution based on COBIT can be tailored to satisfy the FDA Part 11 requirements and by extension other regulatory requirements such as HIPAA. I also help you to address the second question about whether it makes sense in your organization to do it and then I show you how to go about it. I cite evidence suggesting that a single, combined approach will improve the cost/benefit ratio and bring improved IT operating performance and utility to the organization.

I explain the commonality of IT governance and control with the quality system approach to FDA compliance. I show how the key controls for SOX satisfy the design and control requirements of 21 CFR Part 11. I point out the commonalities between IT validation and SOX testing along with some comments on the need to justify this approach for the FDA.

What Attendees will Learn:

• Overview of SOX Controls for IT & FDA Requirements (including expected new Part 11 requirements).
• Information Security (integrity, confidentiality & availability)
• Benefits of Combined IT Control Program
• IT Governance v. Quality System processes
• Information Classification for Finance & FDA purposes
• Mapping COBIT Controls to FDA Requirements-spreadsheet
• Key Processes, Change Management, Access Control etc.
• Justification of Approach for FDA
• Validation for FDA v. Testing for SOX
• Applicability to HIPAA and FISMA

Who Will Benefit:

• IT & Compliance Executive Management
• SOX for IT Implementation Management & Staff
• IT Management & Staff
• Quality Systems Management
• Computer/IT Validation Management & Staff
• Auditing for both SOX and FDA

Instructor Profile:
James Robertson P.E. is the principal of Validation Experts LLC and consults to the pharmaceutical industry on information security and compliance both with FDA regulations and with SOX Section 404 for IT controls. This includes information security, validation, testing and 21 CFR Part 11. Prior to beginning work with computer compliance in pharmaceutical manufacturing 11 years ago, Mr. Robertson spent a full career as an engineer of industrial controls and SCADA systems where he held Vice President Engineering and several management positions. He is named on numerous patents, has published articles, performed training and served as an expert on 14 legal cases.

Mr. Robertson has developed a complete system of IT Controls for a biotech firm that fills the SOX requirement for IT and FDA requirements in Part 11 as well as those for devices and validation.

Currently Mr. Robertson is writing a book that should be available by January 2007 describing how to develop a combined SOX/FDA compliance program for IT, computer and software.

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