08.50 Pharma IQ Welcome

09.00 Chairman’s Opening Remarks

REGULATORY AFFAIRS: EFFECTIVE DOCUMENTATION, TRACEABILITY AND PREPARING FOR THE AUDITORS

09.10 CASE STUDY: Making Agile Work for You, for Your Project, and for Your Company

• Ensuring compliance with regulations throughout the project
• Measuring results and understanding what has been gained in adopting an agile approach
• Finding the right kind of tools for your company and your project and ensuring these tools serve your specific needs and support the risk assessment process in place
• Highlighting recent examples and experience of using agile practices in the development of software in healthcare

09.50 PANEL DISCUSSION: How Should I Approach Documentation For an Agile Project?

Pose questions to a panel of Regulatory Affairs Managers, QA Managers, and Software Developers to hear about the approaches they each take to the documentation process.

11.00 Onward to Approval: Documenting Agile Development for Regulatory Compliance

• Interpretation of the IEC 62304 lifecycle processes in an Agile context
• How to be light and nimble, and still document for design control
• How to fit hazard analysis into the iterative development model
• Where to change quality processes while keeping what works well
• How to achieve complete documentation as an output of the process, rather than as a driver
• Practical examples of results that some teams have achieved

Brian Shoemaker
Prinicipal Consultant
Shoebar Associates

11.40Early Adoption: Successfully Fitting Agile Methodologies into Your Larger Project to Ensure A Robust Software Development Process

• How to get buy in from your management and your developers
• Ensuring you have the right infrastructure in place in order to effectively adopt agile methodologies
• Implementing the process correctly and ensuring process robustness when moving from waterfall to agile
• Rightly integrating verification, validation and a quality management system into your practices
• Effectively finding a good balance between practices whilst staying within regulation

Lucien Jaegers
Project Leader
Philips Healthcare

14.00 Roundtables

A) Overcoming Regulatory Concerns of Developing Agile in Healthcare: Ensuring Your Product and Process is Safe, Reliable and Effective

B) Integrating a Quality Risk Management System into Agile Development

C) Ensuring Management and Engineer Level Buy In and Support for Agile

Lucien Jaegers
Project Leader
Phillips

15.30 Ensuring Fair Traceability and Coverage Throughout an Agile Project

• Effectively managing and maintaining control of each entity in the system
• Keeping changes traceable between different documents
• Making sure you have all the necessary documentation at the end of each iteration to for fill your customer and auditory requirements

Tim McGregor
Software Team Leader
Elekta

16.10 Continuous Delivery: Rapidly Bringing Products to Market Whilst Continually Adding Additional Customer Value

• Setting up your organization and team for continuous scoping and delivery
• Effectively avoiding technical debt
• Test automation and continuous integration
• Ensuring compliance with regulation at all times

Sune Sorensen
Software Manager, New Technology Products
Radiometer Medical

16.50 Chairman’s Summary and Close of Conference