21 CFR Part 11 Compliance 2012 - 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.

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.