Events: 2005 European & U.S. Pharma IT Compliance Week

Carlos Horkan • August 23, 2005
Events: 2005 European & U.S. Pharma IT Compliance Week
European Event: 26 - 30 September, Hilton Olympia, London, UK
U.S. Event (East Coast): 24 - 28 October, Hilton Garden Inn, Washington DC
U.S. Event (West Coast): 31 October - 4 November, Hilton San Francisco

These individually bookable workshops will explain the FDA and European regulators' Latest Thinking for those working to GCP, GMP and GLP regulations. The five 1-day workshops include:

Day 1 - Qualifying IT Networks and Infrastructure
Day 2 - Change Control and Configuration Management
Day 3 - 21 CFR Part 11 Risk Based Compliance
Day 4 - Understanding and Applying Risk Management
Day 5 - Auditing Computerised Systems

***Limited to 40 attendees only per workshop***

ALSO: 2005 European Clinical Research Workshop: Essential SOPs and Required Documentation

This 2-day European workshop will take attendees step-by-step through what SOPs and documentation you should have, what the regulatory agencies demand you have and how to generate compliant documentation that meet both regulatory and organisational requirements. In addition, the sessions and workshops will look at how your organisation can benefit from the compliance activities.

Expert speakers will cover topics including:

Regulatory requirements and guidelines governing SOPs - GCP, FDA and ICH

What SOPs and documentation are needed for clinical research

What the regulators want and typical inspection findings

How to best deal with audits and inspections

Process design vs. writing SOPs

SOPs vs. procedural documents

Critical components of SOPs - details to include

How to design, write, implement, approve and review SOPs and documentation

Quality control, validation and revision of SOPs

How to best maintain compliant SOPs

What happens when SOPs are not compliant?

SOPs for large vs. small organisations

Developing a hierarchy and company wide policies and SOPs

SOP Training

Electronic SOPs - problems, practical solutions, benefits and 21 CFR part 11

For further details please go to
http://www.rcwg.org

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