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CSC: 21 CFR Part 11 - Procedural and Technology Requirements
Wednesday, 5 November 2003

- Location -
ISA Headquarters 67 Alexander Dr
Research Triangle Park, NC United States

Conference Overview

Now that the FDA has narrowed the scope of 21 CFR Part 11, What is your strategy? How can you benefit? This conference will address both the procedural and technological aspects of 21 CFR Part 11. The technological aspects are addressed more frequently, however, no computer system can be compliant unless these procedures are addressed. Speakers will discuss the latest interpretation of 21CFR Part 11 along with computer system compliance strategies.

Part 11 Overview – Most Recent Interpretation!
By: Raymond Miller, Ph.D., Miller Regulatory Consulting

Much of the misunderstanding around 21 CFR Part 11 is derived from not understanding the context of the rule and its intended use in industry including definitions of terminology, security, data transfer issues, and audit trails versus the associated supporting procedural infrastructure. The basic concepts are presented with an understanding of the associated risks to better determine legal liability and increase the likelihood that systems are implemented on schedule and within budget. There are many Part 11 issues that are surrounded by confusion and/or multiple interpretations. There will be a discussion of FDA’s view on the various sections of the Part 11 regulation.

Ray Miller, President of Miller Regulatory Consulting, Inc. is a renowned leader who recognizes and applies emerging technical capabilities and trends to greatly improve systems and processes in the Life Sciences industries. Throughout his 25 years in the Life Sciences industry, Ray has synergistically bridged diverse technical specialties through the coordination of people, hardware, and software. The success of Dr. Miller’s innovations is related to his attention to the human aspects of technology adaptation.

Part 11 Procedures - What is Needed Now?
By: Edward Johnson,Esq.,CQA., Stelex

With FDA’s emphasis on a science and risk-based approach to product quality regulation, companies are looking for cost effective means to meet requirements while improving the bottom line. This presentation will address common sense approaches to regulatory and business issues facing pharmaceutical companies. You will come away with specific information on how to ensure compliance while leveraging your existing investment.

Ed Johnson is Regulatory Affairs Counsel and Compliance Coordinator with Stelex. Ed is responsible for providing regulatory and legal guidance to Stelex in the development and review of contracts, licenses and quality documentation, including documentation in support of submissions to FDA. He provides interpretations of Federal, state and international laws and regulations to Stelex and its clients, and is one of Stelex’s primary liaisons to FDA in this area. Ed serves as management representative and was one of the co-founders of Stelex’s Quality Auditing Services department. As a member of that department he has performed second- and third-party supplier and quality systems audits for clients

The Role of Biometrics in 21 CFR Part 11
By: Cliff Kittle, SAFLINK Corp.

21 CFR Part 11 was created for the purpose of defining how product design and manufacturing electronic records and electronic signatures are controlled. Recent events have heightened the concern regarding network, information, and intellectual property security and these concerns are partly addressed in Part 11. A study performed by the American Society for Information Security and Price Waterhouse pointed out the fact that Fortune 1000 companies lost $45B in intellectual property in 1999. A majority of this lost intellectual property was in the manufacturing process and R&D segments of the corporations. While biometric technology for authentication is not the complete answer to the problem, it is an integral part of the total solution. We will discuss where and how it fits in a corporate security solution. This presentation will address the technical and business benefits of biometric technology authentication in achieving the Part 11 requirements.

Cliff Kittle has over 25 years in the sales and marketing of software solutions to process and discrete manufacturing industries. During this time, he has been instrumental in the development of enterprise applications for government regulated applications such as the pharmaceutical new drug application process and airline maintenance information management procedures. Currently he is involved in assisting organizations who are attempting to meet the Part 11 requirements for secure identification and authentication as required for electronic records and electronic information.

Compliance Strategies for the 21st Century
By: John Clark, CompuVal, Inc With the new Part 11 guidance that the FDA has released, Computer System Compliance has once again become a topic for debate. This presentation will outline computer system compliance that will meet today’s interpretation of Part 11 and can be used as the foundation for any future interpretations of the regulation.

John Clark has 15 years pharmaceutical industry experience. During this time he has performed Validation, cGMP Training, Quality Systems Building, Quality Control Testing and Compliance Auditing. He has served in a variety of roles from cGMP Quality Assurance Manager to the Quality Unit Project Lead for Computer System Remediation and Part 11 Compliance project. Currently he performs cGMP training, application development, and serves as project manager for computer validation and Part 11 compliance projects.

Authority Checks & Audit Trails
By: Phil Koehler, Iconics

Learn what SCADA software tools are required and how to best minimize loss for an FDA 21CFR11 compliant installation. Topics covered in this presentation will range from audit trails and traceability to e-Security Management with and without the use of Biometric devices. Throughout the presentation, various alarming, trending, reporting and visualization tools will be demonstrated in accordance with CFR21-11 criteria.

Phil Koehler has over 20 years of experience in the field of technical sales and marketing management. Phil received his BS in Marketing from Drexel University and has been an active member in various technical societies (including ISA, ISBT and MANA) throughout his career. He is considered an expert in material processing technology and is listed in the “Who’s Who” of the International Society of Beverage Technologists.

Part 11 Initiatives (Panel Discussion)

With the FDA providing a guidance document for Part 11 what are pharmaceutical companies doing in response as far as new computer system selection and validation are concerned. Does this guidance open the door to allow more vendors to be utilized and does this affect any decisions to upgrade systems? How does your company view this development and how does this play into your corporate computer compliance strategy? Panelists from both large and small pharmaceutical manufacturers, integrators, and suppliers will present their viewpoints.