Jan. 7, 2013
-- 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.