8:50 Welcome Address And Chairperson’s Opening Remarks

9:00 Case Study: Moving Towards GAMP 5

The consequences of lacking potent control of the IT Infrastructure are significant. The recent released GAMP 5 is an even more powerful and more practical guidance for the infrastructure professionals to develop best practices and ensure control and compliance.

• Learning the differences between GAMP 4 and GAMP 5
• Establishing best practice: using GAMP 5 guidance to develop your qualification framework
• Creating flexibility and avoid duplications

Diane Hancock
Associate Quality Assurance Consultant
Eli Lilly & Co.

9:45 Applying Critical Thinking On Validation To Achieve More With Less – Interpreting TIR 36

• Understanding the key highlights of TIR 36
• Why critical thinking is important in the process
• Leveraging the TIR 36 to achieve more with less

Barbara Beiersdorf
Principal Regulatory Compliance Specialist
Medtronic

11:00 Implementing A Risk-Based Approach For IT Infrastructure Deployment And Change Control Supporting GMP Applications

• Identifying the most significant threats (e.g. virus infection) to IT Infrastructure supporting GMP applications
• Examining the development of a risk-based approach for IT Infrastructure (SC1) deployment and change control (e.g. security patches, version upgrades)
• Benchmarking against achieved progress toward compliance and operational excellence
• Learning how to use IT Infrastructure to support GMP manufacturing applications

John Patterson
Director IT Compliance – Manufacturing
Merck & Co.

11:45 Discussing Some Of The Global Initiatives On The Standardization Of IT Infrastructure Qualification And Validation

• Examining key elements for standardization: quality, productivity and security
• ONE Standard, ONE Test, ONE Approval through standardization of the processes
• Exploring consensus developed International Standards
• Managing quality processes with global standards for computerized system