IVT’s 11^th annual event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical). The pharmaceutical industry has been awaiting the rewrite of CFR Part 11 for several years, and while many believed it would come in 2009, the re-write release date is yet to be published..  Currently, the information gap is being filled by organizations like the European Commission and ASTM, but formal guidance and education are yet to be released.. 

In this ‘build-your-own conference’, attendees can choose from dozens of interactive workshops and sessions to create an event that suits their specific validation need.  Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away leading edge information that can be immediately implemented.

Key topics to be addressed:

• A Risk-Based Approach to CSV
• EU Annex 11 – Europe’s equivalent to Part 11
• Project and Requirements Management
• Network Qualification Planning
• FDA Inspections of Computer Systems
• GAMP®  (www.ispe.org/GAMP) and ASTM 2500
• ERP System Validation
• Validate Legacy Systems
• CSV User Requirements
• Write Quality Test Scripts
• Form a Partnership Between QA and IT
• Audit Trails an Security
• FDA’s Current Enforcement Strategy – FDA 483s and Warning Letters
• A Lifecycle Approach to CSV
• Change Control and Configuration Management
• Validating Configurable-Off-The-Shelf-Software
• Data Conversion Management
• CSV Training Programs
• High, Medium and Low Risk – what does this mean?
• Programmable Logic Controllers (PLC) Validation
• Electronic Records and Their Lifecycle
• Master Planning and Vendor Auditing
• Documentation Requirements for Validation
• Implement CSV Globally
• Configuration Management for Infrastructure Components
• Open Versus Closed Systems
• Software Development, Testing and Validation
• Use Excel Spreadsheets in a Regulated Environment
• How Much Validation is Enough
• Conduct a Gap Analysis of your CSV Process
• Long-Term Maintenance of Electronic Records
• Ensuring Internet Applications are FDA Compliant
• LIMS Validation Strategy
• Strategies to Archive Electronic Records

Sponsors/Exhibitors:

Hear what some of our previous attendees had to say:

“Hearing from former and present FDA representatives was a real benefit”
-- Joseph Zec, Clinical Software QA Manager, Boston Scientific

 “I benefited from this conference…. the workshops and sessions were excellent!”
-- Mohammeda Rahman, CSV Validation, Otsuka

“I have been attending these kind of conferences for 10 years and this was the best by far!”
-- John Zenk, Sr. CSV, Emergent Biosolutions

“Level of presentations was appropriate for experienced CSV individuals.”
-- Diana Soli, Senior QA Specialist II, Purdue Pharma

For more information or to register, please contact the Institute of Validation Technology toll free by phone at 1.888.736.8547 or via e-mail at ivtreg@ivthome.com.