Validation of Computer Systems in the Pharmaceutical Industry conference, 2005 London, UK
This conference will provide a forum for validation and IT/IS professionals
to hear from other specialists about the technical implementation of
legislation governing the validation of computer systems in the
pharmaceutical industry. It will also give the opportunity to share their
knowledge of controversial issues and real problems.
Issues that will be discussed:
* RISK MANAGEMENT: How do you apply drug risk management to technology? Plus
case studies on risk-based approaches for laboratory,information and
* PART 11: How 21CFR Part 11 applies to data and system suppliers
* PATIENT DIARY TRACING: A look at the new HIPAA regulation
* GCP ISSUES: Concepts around open or closed systems, validation
planning and test script writing, global/large scale GMP computer
* PANEL DISCUSSION: ´Differences and similarities in FDA vs EU guidance´
Speakers include representives from GlaxoSmithKline, Aventis, Bayer Healthcare and Eli Lilly.
You can visit the conference’s website here.