Risk Based Validation of Computer Systems and Part 11 Compliance

FDA and other agencies require to “Base software and computer validation and other controls of electronic records on a justified and documented risk assessment”. For example the PIC/S Guide on using computers states: “For GxP regulated applications it is essential to carry out a properly documented risk analysis.

The inspector will consider the potential risks as identified and documented by the regulated user to assess the fitness for purpose of the particular system(s)”. Risk based compliance is great because when implemented right it helps to reduce overall validation and compliance costs by focusing resources on high risk systems and save costs on low risk systems. Frequently risk categories are easy to define but the challenge comes when users should define suitable actions for each category.

For easy implementation, attendees will receive
2 SOPs
Risk-based Validation of Computer Systems
Risk assessment Used for GxP Environments
Risk Management Primer: 71 pages
Risk Management in the (Bio)Pharmaceutical and Device Industry

Areas Covered in the Session :
FDA/EU and business requirements for risk assessment
Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE, PIC/S
Practical approaches for risk assessments of computers and electronic records
Going through a practical exercise: Relative risk ranking of regulated records
Developing a risk based software and computer validation program
Developing a risk based Part 11 compliance program
Planning and implementing for risk based specifications, vendor assessment, installation, testing, change control, back-up, and contingency planning
Risk assessment for network infrastructure
Implementing risk based security, audit trail, back-up, archiving and retrieval of electronic records
Documenting the decision for management and the FDA
Practical examples and specific recommendations from laboratories, office computers and production

Who Will Benefit:
A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Clinical testing laboratories. The teams that will benefit the most are:
QA Departments
QC Departments
IT Departments
Analysts and lab Managers
Regulatory Affairs Departments
Training Departments
Documentation Departments

Dr. Ludwig Huber

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, 21CFR Part 111 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. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance