Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies

This FDA Inspection training provides concrete strategies for planning remediation projects.

Why Should You Attend:

Today's manufacturing and quality environments are highly automated and computerized. Manufacturers facing FDA pre-approval inspections (PAI) as well as those who will be re-inspected following inspectional observations (FDA-483), warning letters and other compliance issues can expect FDA to pay increasing attention to automated manufacturing systems and computerized quality systems. If you have outstanding issues know to your quality unit or to FDA, now is the time to initiate remediation efforts! This presentation provides concrete strategies for planning remediation projects.

Areas Covered in the seminar:

• Review current FDA inspection of automated manufacturing systems.
• Review current FDA inspection of quality system software, such as complaints, CAPA, etc.
• How do I determine which systems require remediation?
• What are the planning issues for a remediation project?
• Special considerations for multi-site and global systems
• Software validation concerns.
• 21 CFR part 11 (Electronic Records and Electronic Signatures) concerns.
• Remediation project planning guidelines.