Software Validation: Avoiding FDA Warning Letters and Consent Decree

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.





Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation.

He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 250 mission critical laboratory, clinical, and manufacturing software implementation projects.

His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Course Includes:

Limited Time Offer - Only $229!

Here is the Agenda

Who Will Benefit

GMP, GCP, GLP, regulatory professionals QA/QC IT Auditors Managers and directors Software vendors, hosting providers

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