8:50 Welcome Address And Chairperson’s Opening Remarks

9:00 Keynote: Adopting Quality By Design (QbD) Approaches On IT Infrastructure To Build Compliance And Security Into Your System

• Introducing and putting QbD in place for infrastructure – where did it begin?
• Developing a powerful suite of tools to automate the compliance and security process
• Mitigating risks by detecting and fixing the system loopholes
• Sharing case studies on how the system reacts in different situations
• Striving for long-term business results – becoming the legendary partner of your business

Randy M. Slain
Worldwide Technology Infrastructure, Global Network Services, Qualification and Security Global Lead
Pfizer Inc.

9:45 Leveraging A Life Cycle Management Approach For IT Infrastructure Qualification

Keeping computer infrastructure in a compliant state is becoming more and more critical for pharmaceutical and biotech companies. Taking a life cycle management approach, along with effective risk analysis techniques, are vital to a successful infrastructure qualification program.

• Enabling compliance with a clear understanding of the infrastructure requirements and verification activities
• Considering key elements for a successful infrastructure qualification program: risk analysis techniques, project management strategies as well as infrastructure life cycle approaches
• Designing and deploying the program in a cost-effective and efficient way

Carolyn Stockdale
Director, Global Computer Systems Validation
Premier Research Group

11:00 Case Study: Creating Infrastructure Qualification Programs With Outsourced IT Hosting Providers

• Establishing a productive and constructive collaboration with the providers
• Drafting well-suited service level agreement – effective tips
• Developing qualification programs with the vendors
• Sharing lessons learned and crafting plans for the future

11:45 IT Infrastructure Qualification And System Validation – From The IT Vendor Perspective

Keeping computer infrastructure in a compliant state is becoming more and more critical for pharmaceutical and biotech companies. Taking a life cycle management approach, along with effective risk analysis techniques, are vital to a successful infrastructure qualification program.

• Laying out the IT vendors’ internal process to increase better communication and collaboration
• Understanding the vendors role in compliance
• Specifying the challenges on developing qualification program from vendor’s perspective

* Speaker and sponsorship opportunities available. Please contact cathy.gu@iqpc.com for more information

1:30 Case Study: Managing Vendors And Their Quality Systems Through Effective Auditing

• Understanding when and how compliance fits into IT using vendors with hosted solutions
• Learning when and how should a company audit
• Managing vendor quality systems with vendor resistance, setting up matrix, contracts, and predictable development schedules

Theron J Bogan III
CTBS, IS Compliance Manager
LifeNet Health

2:15 FDA Design Controls And Requirements For Computerized Medical Devices

• Uncovering the common gaps in design control
• Comparing design controls for medical devices and pharmaceuticals
• Updating design controls and requirements
• Understanding the FDA requirements when outsourcing

Richard C. Chapman
General Engineer, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health (CDRH)
U.S Food and Drug Administration

3:30 Developing Effective Risk Management Strategies In A Virtualized Environment

• Understanding the regulatory requirements for a virtualized environment
• Streamlining the infrastructure qualification and compliance process
• Managing the non-employee users

Sherman L. Altick
Associate QA Consultant
Eli Lilly & Co.

4:15 Panel Discussion: Risk Based Approach To Computerized System Validation

This session will provide common framework and regulatory references and risk models to support panel discussion on effectiveness of a Risk Based Approach to Computerized System Validation

• Examining core ICH principles & GAMP principles for Risk Based Approach to Computerized Systems
• Discussing regulatory references for a risk based approach

Joyce L. Morrow
Manager, Automation Compliance
Merck & Co.

5:00 Closing Remarks From The Chair And End Of Day One