Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
July 25, 2012
Location
Online Event
2600 E. Bayshore Road
Palo Alto, California 94303
USA
Description
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.
Organized by
Compliance Online
2600 E. Bayshore Road
Palo Alto, California 94303
United States of America
More Information
Contact: Referral
Email: referral@complianceonline.com
Phone: +1-650-620-3915
Event's Website
