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 Should Attend:

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
• Consultants

Course Director: 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).