Agenda

09:00	Registration, Tea & Coffee
09:30	Welcome & Introduction
09:45	What Is a Service Oriented Architecture?
	Special Guest Speaker: Phil McLaughlin, Principal Consultant from Oracle Corporation will describe what a Service Oriented Architecture is, what it means to the world of traditional business applications and some of the advantages that SOA can bring in the world of disparate software applications, mergers and acquisitions.
10:30	Morning Tea & Coffee
10:45	Session 1: Aligning the IS Quality Management System with Industry Standards
	In this session the workshop will address the questions of "What are the advantages and disadvantages of formalising IS processes under a Quality Management System (as per the GAMP® Good Practice Guide: IT Infrastructure Control and Compliance)" and "How do we align the need for regulatory compliance with Industry Standards such as ITIL and CobiT?"
11:45	Session 2: Validating Collaborative, Workflow Applications.
	In session 2, the workshop will consider when collaborative solutions such as Microsoft SharePoint® or Oracle Collaboration Suite® require validation and how to go about cost-effectively proving that such solutions are ‘fit-for-purpose'. This session will also look at the impact that the next version of Microsoft Office® will have in the working environment and the potential implications for validating standard desktop applications.
12:30	Lunch and Networking
13.30	Session 3: Middleware: Qualification or Validation?
	Picking up on the theme of SOA, session 3 will consider when ‘middleware' such as Oracle Fusion® or Microsoft Biz-Talk® crosses the divide between Infrastructure Qualification and applications validation. This session will also present an updated approach to business process modelling in the regulated Life Sciences industry, allowing users to better define when 21 CFR Part 11 may or may not apply.
14:15	Session 4: Validating Internet, Extranet and Intranet Applications.
	With the coming of so-called ‘Web 2.0', this session will address the question "What are the specific issues that need to be considered when validating networked applications?" and considers how the use of the public Internet (rather than an organisations Intranet or Extranet) complicates issues. Attendees are invited to discuss examples of their own Internet enabled applications and an appropriate approach to validation.
15:00	Afternoon Tea & Coffee
15:15	Session 5: Identity and Authentication Management.
	IAM is a core part of a Service Oriented Architecture and brings many advantages in terms of ‘single sign-on'. However, problems with the IAM infrastructure can potentially compromise the integrity of multiple applications. In this session attendees will consider how modern Identity and Authentication Management solutions support a compliant Service Oriented Architecture.
15:45	Session 6: Integration Testing of a Service Oriented Architecture.
	With so much emphasis on SOA, it is useful to consider the extent to which integration testing of different layers and components is required. In the final session of the day attendees will discuss how standard IS platforms and integrated processes should qualified and when functional testing (OQ) may be required?
16:15	Questions & Answers
	Providing a chance to revisit any unanswered questions raised during the day, the Q&A session also provides an opportunity to ask any other compliance and validation related questions. After the formal conclusion to the proceedings, Business & Decision's experts will be on hand to discuss any specific issues on a one-to-one basis.
	Summary, Feedback & Close

Objective
Business & Decision organises a regular series of industry workshops in order to:

• Allow the Life Sciences user community to identify common issues in the overlapping areas of business efficiency, regulatory/IT compliance and computer systems validation.
• To provide a forum to discuss these issues.
• To identify and share pragmatic, industry best practice solutions.
• This specific workshop is intended to identify regulatory issues associated with the ‘Service Oriented’ IS organisation, including new and emerging technologies, processes and people.
  

Workshop Format
Unlike other seminars or meetings, where the majority of time is spent listening to ‘talking heads’, the workshop format is designed to allow maximum interaction between attendees.  Facilitated by experienced consultants from Business & Decision and invited industry experts, each session will provide an update on current IS technology and is designed to outline specific issues and to discuss them in an interactive forum.  Attendees are invited to prepare for the workshop by considering the relevant issues within their own organisation and how some of these problems are being tackled.  Because the objective of the workshop is to facilitate an open discussion of problems and solutions, all information exchanged is treated on a confidential basis and all attendees are expected to respect this principle.  For those who would like hardcopies of presentations to annotate during the workshop, copies will be available to download a week before the event.

Who Should Attend?
Attendance at the workshop is by invitation only and is intended for the end user community. This workshop is intended for those responsible for:
Implementing a service oriented IS model, 

• The provision of service oriented information systems,
• The validation / qualification or regulatory oversight of IS services,
• The project management of associated projects.

Typically this will include senior management and system owners, quality managers, staff responsible for computer systems validation, CIOs/IT managers and project managers.

What Does It Cost?
Attendance at this event is free of charge. Refreshments and a buffet lunch are provided. Attendees are expected to pay their own travel and accommodation costs.

How Many Places Can I Book?
Attendance from a cross section across the organisation is most beneficial at such a workshop. However, the workshop format works best with representatives from different organisations.  Places are limited and are generally allocated on a first come, first served basis and early registration is advised.  The organisers may request companies to restrict numbers from their organisation in order to ensure a representative sample from the industry.

How Do I Reserve Places at the Workshop?
Please complete the booking form below. 

If you wish to register multiple people from your company please enter their names and contact information in the "Additional Attendees" section. If these people are based at a different address than the one you intend to enter in the "About You" section, we would be grateful if you completed a separate registration form for these people so that we have a record of this additional address.