How do you apply the new risk-based approach to IT infrastructure? Whether you are new to this or quite experienced you get useful and immediately applicable GAMP 5 guidance on:
- Understanding the scope of IT infrastructure
- Establishing compliant IT infrastructure
- Maintaining compliant IT infrastructure (i.e., change control)
At the conclusion of this session, participants will be able to:
- Understand IT infrastructure scope (see GPG IT, Figure 1.1)
- Establish a compliant IT infrastructure
- Keep the IT infrastructure compliant during operation (i.e., control)
- Apply risk-based approach to IT infrastructure
- Successfully implement application configuration
- Establish application compliance
Yves Samson initially graduated as automation engineer and computer scientist. After his studies in Grenoble (France) and Münster (Germany), he joined Novartis (formerly Ciba-Geigy) where he worked during 11 years as application engineer for process control systems, project engineer, technical project manager, and site engineer (maintenance & projects). Yves takes care of computerised system validation since 1992. Since 2000, he works as consultant, auditor and trainer for all aspects of quality management in automated and IT environments particularly within the regulated industry – pharmaceutical industry, medical device manufacturing, blood transfusion services – and for its suppliers. He supports Quality Assurance and development departments regarding e-compliance for automated and IT systems. In 2002, he founded the consulting company Kereon AG, Basel. Yves is strongly engaged within ISPE; he edited the French version of GAMP® 4 and GAMP® 5. He is also member of the French affiliate board. Yves is co-founder and chair of the French Speaking GAMP® Community of Practice “GAMP® Francophone” and member of the GAMP Europe Steering Committee. He translated and edited the French version of the PIC/S Guidance PI 011 about: “Good Practices for computerised systems in regulated ‘GxP’ environments”.
Jerry Hare is president of Voice of Compliance LLC. He has been involved in the pharmaceutical industry for twenty years with expertise in computer validation, quality systems, and QMS software standards. Prior to founding Voice of Compliance LLC, he was Director Global Computer Validation at GlaxoSmithKline. His more than nineteen years experience at GlaxoSmithKline includes leading and managing computer validation efforts for strategic systems, auditing suppliers, and establishing corporate policies and operational procedures associated with regulatory records and computer validation. Hare has been a member of ISPE for more than eight years and has been a contributor to various GAMP guidance documents and has been an occasional speaker in the industry. He is currently working with North Carolina's Bio-manufacturing Training and Education Center to develop a concentration of computer validation courses. Hare is a graduate from North Carolina State University with Bachelors and Masters of Science degrees.