Compliance Trainings, Online
2015-08-20
Description : The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation. For easy implementation, attendees will receive SOP: Validation of Commercial Off-the-Shelf Computer Systems SOP: Development and Maintenance of Test Scripts for Software and Computer Systems Checklist: Using computers in FDA regulated environments Areas Covered in the Session : US FDA and EU requirements and enforcement practices Learning from recent FDA 483's and warning letters Selecting the right validation model: qualification vs. verification Eight fundamental steps for computer system validation Structure and example of a validation plan Justification and documentation of risk levels Example qualification document for suppliers of commercial systems Examples for requirement and functional specifications? Example for IQ protocols OQ test protocols: development, execution, approval - examples Documentation of ongoing performance Validation of existing systems Structure and example of a validation report Step-by-step case studies from laboratories and manufacturing for easy implementation Who Will Benefit: A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are: IT managers and system administrators QA managers and personnel QC Lab managers and üersonnel Validation specialists Regulatory affairs Training departments Documentation department Consultants
|