Computer System Validation Description: Computer Validation is required by the GMP regulations and FDA has posted a Guidance Document on Electronic Signatures. Unfortunately, many in the pharmaceutical industry are still uncomfortable with what should be done to validate a computer system with the result that they over-work the process to allow a greater level of confidence that they have done the right thing. This presentation will simplify the process and ease your sleepiness. When computers are used for anything other than e-mail or face book, most people get squeamish. For example, in one case I was involved in, when the company announced that they were going to renovate and automate a manufacturing area, all of the people but one quit because they were convinced that they couldn't do the job if they had to work with computers. I solved that problem and put the entire group back to work but there is still a large portion of the population that is literally afraid of everything inside the computer's shell. You can't validate something that you fear or do not understand. This presentation will begin the process of understanding and allow a faster and better validation process. Why Should you Attend: If you are involved with computers anywhere in your workplace, this presentation is designed for you. Objectives of the Presentation: To improve understanding and simplify your validation and use of computerized systems in the workplace. Who can Benefit: o Managers and practitioners of validation groups o
QA
o
AC Manufacturing areas using computers.
o o
Tuesday, January 15, 2013 10:00 AM PST | 01:00 PM EST Live Session for one participant
Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)