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:
Who will benefit:
The following individuals or disciplines will benefit from attending this Webinar:
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: firstname.lastname@example.org