2005 European Pharma IT Compliance Week
26th - 30th September 2005
Hilton Olympia, London, UK
Day 1
Qualifying IT Networks & Infrastructure Understanding
Why Network Qualification is Important Now Compliance
Roles and Responsibilities Managing Regulatory Risk
in the IT Department Controlling Qualification and
Specifying the Network Qualifying Components and Reporting
the work Maintaining the Qualification : Impact of
Change Control IT Applications :- Validate or Qualify?
How the FDA will inspect the IT Department
Day 2
Change Control & Configuration Management Understanding
FDA and EU Regulations for change control Understanding
Configuaration Management and Linking it with change
control Change Control for IT Networks and Infrastructure
FDA Cybersecurity Guidance for Off-the-shelf software
Day 3
21 CFR Part 11 Risk Based Compliance Overview GMPs
for the 21st Century and FDA Review of 21 CFR 11 Part
11 Changes
Interpretation of Part 11 by the GxP predicate rules
Understanding and Applying Risk Based Controls for
Electronic Records Records Retention : Options for
Long Term Storage Risk Based Approaches for Audit
Trails now Ensuring Data Integrity Exploiting the
benefits of Electronic Signatures
Day 4
Understanding & Applying Risk Management Introduction
to Risk Management Defining a General Risk Management
Process and Framework Do I Need to validate my Computerised
System Risk Analysis Methodologies for Computerised
System Validation
Applying Risk Analysis Methodologies Practical use
of BS7799 and NIST SP800-40 Risk Assessment Methodologies
Day 5
Auditing Computerised Systems Current Regulatory Requirements
for Computerised Systems Planning an Audit How to
Audit the Developing System How to Audit the Operational
System How to Audit Information Technology Department
To register call +44 (0)20 7372 1301, Fax +44 (0)870
487 8367, email: info@rcwg.org
or provisionally register online at http://www.rcwg.org
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