QCSV Inc. & REGULATORY COMPLIANCE COMMITTEE OF THE MEDICAL DEVICE CLUSTER Invites you to the Conference Proper Use & Validation of Excel Spreadsheets in an FDA Regulated Environment EVENT IS OPEN TO ALL MEDICAL DEVICE COMPANIES (FREE OF CHARGE)

Excel spreadsheets are a very important tool for laboratory analysts in FDA Regulated companies.  The use of spreadsheets can help laboratory analysts to speed up repetitive mathematical calculations and decision making, but when this tool is not managed appropriately, the company may be subject of regulatory citations.    Multiple companies have already received FD-483 observations for the incorrect use of Excel Worksheets in Laboratory activities.     This conference will show the audience the position of the FDA regarding the use of Excel Worksheets in a regulatory environment and a pragmatic approach for the validation of spreadsheets.    At the end of the conference it is expected that participants will understand the implications of using Excel Spreadsheets for regulatory activities

MAIN SPEAKERS ·  Juan O. Pérez - President, QCSV Inc. ·  Dennis Cantellops, FDA Investigator – San Juan District ·  Tyson Mew – President, Ofni Systems

Who Should Attend § Quality professionals responsible for company regulatory compliance. §QC Managers and laboratory analysts who use Excel Worksheets to document mathematical calculations or graphics. §Quality Assurance personnel responsible for product dispositionand for the approval of validation protocols. §Information Technology and Technical Services personnel responsible to ensure the system qualification and for the proper use computerized solutions.

Thursday, October 30th, 2008 at 8:30 am - 12:00 pm At the Theater of the Puerto Rico Industrial Development Company (PRIDCO) #355 FD Roosevelt Avenue Suite 404 Hato Rey, Puerto Rico

RSVP:Aurelis Cruz Prtec (787)834-5700