Webinars >>FDA Regulations
Software Validation: Avoiding FDA Warning Letters and Consent Decree 

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. Improper or ineffective software validation leads to finding of deficient quality systems during FDA audits.
 
This seminar 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. 
Areas Covered in the Session:
  • FDA software validation requirements
  • Common types of software that require validation
  • Review if FDA Warning Letters and Consent decrees related to software
  • Common FDA audit findings for software validation
  • Best practices to bring software into compliance
Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:
  • IT/QA personnel
  • GMP and QSR personnel
  • Regulatory affairs personnel
  • Senior executives of FDA-regulated firms
  • People investing in such companies
Date: September 5, 2019
Time: 12 PM EST
​Duration: 60 Minutes

Speaker: Mukesh Kumar
​​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com