As one among the most leading causes for warning letters and consent decrees, software validation and its compliance are essential to keep your business ready for FDA audits and inspections. Learn best practices to conform to FDA software validation requirements in this webinar with a leading FDA and regulatory affairs expert.
This webinar will provide practical tips for achieving FDA-acceptable software validation of general computer systems and computerized equipment. Case studies will be used to highlight common mistakes and possible solutions. Case studies will also illustrate the common FDA audit findings for software validation.
Why Should You Attend:
Computerized manufacturing and quality systems are frequently cited by FDA auditors to be deficient in adequate validation leading to FDA 483s, warning letters and consent decrees. Software validation issues with computerized systems are responsible for multiple product recalls as well. During FDA audits, improper or ineffective software validation can lead to findings of deficient quality systems.This webinar will provide practical tips for achieving FDA-acceptable software validation of general computer systems and computerized equipment. Case studies will be used to highlight common mistakes and possible solutions. Case studies will also illustrate the common FDA audit findings for software validation.
Areas Covered in the Webinar:
- FDA software validation requirements
- Common types of software that require validation
- Review of FDA warning letters and consent decrees related to software
- Common FDA audit findings for software validation
- Best practices to ensure software compliance
Who Will Benefit:
- IT/QA personnel
- Internal auditors
- External auditors
- Consultants
- GMP and QSR personnel
- Regulatory affairs personnel
- Senior executives of FDA-regulated firms
- People investing in such companies
Course Provider
Mukesh Kumar,
