FDA Computer System Validation Steps

Thursday, Apr 20, 2017 at 10:00 AM to 1:00 PM EST

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Thursday, Apr 20, 2017 at 10:00 AM to 1:00 PM EST

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.

Learning Objectives :

  • 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 :

  • QC managers
  • QA managers and personnel
  • IT administrators
  • Regulatory affairs
  • Training departments
  • Validation groups
  • Documentation department
  • Consultants

Instructor Profile :

Ludwig Huber, Ph.D., is the director of Lab compliance 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 CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website www.ludwig-huber.com.

David ben

http://www.grcts.com

GRC Training Solutions is a premier training and solutions company that conducts high impact trainings in Corporate Governance, Regulatory Compliance, Quality Management and Risk Management. GRCs training modules are designed and facilitated by industry experts who possess a strong theoretical and working knowledge of the required regulatory compliance requirements. GRC Training Solutions uses Government and industry best practices and relevant software tools to help companies of all sizes accelerate business performance by helping them understand how to effectively operate within the various guidelines and regulatory frameworks.The training modules are designed for senior and mid level management and executives.

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