Computer System Validation: Step-by-Step

Why Should You Attend:

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 five 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.

Hand-outs:

For easy implementation, attendees will receive:

• SOPs: 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

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Webinar:

• US FDA and EU requirements and enforcement practices
• Learning from recent FDA 483s 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
• Examples of 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 units for easy implementation

Who Will Benefit:

• Personnel from the pharmaceutical and medical device industry
• Manufacturers of pharmaceutical ingredients
• Contract manufacturers and laboratory staff
• IT managers and system administrators
• QA managers and personnel
• QC and lab managers
• Validation specialists
• Regulatory affairs personnel
• Training department personnel
• Documentation department personnel
• Consultants

Dr. Ludwig Huber
Director and Chief Editor, Labcompliance

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

Follow us :