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
Consultants
FDB1766
