HORSHAM PA USA -- AUG 2005 -- The Drug Information Association (DIA) will hold its 10th Annual Computer Validation and 3rd Annual IT Conference together for the first time, on Sept 12-14 2005, at the Williamsburg Marriott Hotel in Williamsburg VA.The combined conference will focus on the challenges and opportunities of IT and validation requirements brought on by emerging standards and the development of new tools.The program will specifically discuss 21CFR Part 11 and questions surrounding it, such as whether it helps clarify how electronic records and electronic signatures may be used in all regulated environments.
KEY FEATURES:
- Sessions on Sarbanes-Oxley from an IT & Compliance Perspective, and Validation of Adverse Event Systems.
- The meeting will conclude with a plenary session, where representatives will provide their industry insights.
PRE-MEETING TUTORIALS:
Those attending this conference will also have the opportunity to participate in one of four pre-meeting tutorials on Sept 12 2005.
Pre-registration for these tutorials is highly recommended, due to limited space.
The tutorials are: Advanced Auditing of Clinical Research Systems for Validation; Practical Risk Management - Threat, Impact & Vulnerability vs Cost & Reward of Mitigation; Basic Concepts of Computer System Validation; and Computer Validation Reality Check for User Acceptance of GXP Applications.
WHAT YOU WILL LEARN:
Upon completion of the conference, participants will be able to describe predicate rule record keeping requirements, recognize the relationship between predicate rule requirements and Part 11 requirements, and discuss emerging national and international industry standards for electronic data keeping and electronic signatures.
WHO SHOULD ATTEND:
The conference will be of particular interest to professionals in the pharmaceutical industry, government and academia who are involved with information technology, electronic data/EDC systems, quality control/assurance, regulatory affairs, clinical data management, biotech and good clinical practice.For more information and to register online, download the brochure at: www.diahome.org/Content/Events/05009.pdf
ABOUT THE DRUG INFORMATION ASSOCIATION:
The Drug Information Association serves over 25,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide.
Through its domestic and international meetings, training courses and workshops, the DIA provides a neutral, global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes.
Headquartered in Horsham PA USA, the association is led by its volunteer-based Board of Directors and executive management team.
