Event Overview:
Computer Systems Validation is an activity that presents complex challenges to the life sciences community. Conflicting information from the FDA and the evolution of multiple industry standards for validation including Good Automated Manufacturing Practice (GAMP) 4 and 5 have caused confusion and uncertainty within the industry.

Join us to hear from industry and compliance experts that know the facts around computer systems validation. Hear about common challenges and how to overcome them. Discuss the definition and scope of validation (including SaaS solutions), identify what the FDA says about validation, and learn best practices that you can implement in your organization to help ensure your systems are compliant with FDA’s expectations and company business objectives.

Key Learning Objectives: » Discuss the scope of validation and how it applies to your systems » Understand the requirements of FDA’s 21 CFR Part 11 Validation regulation » Learn best practices for validation activities and documentation that will meet FDA expectations and ensure system compliance

Who Should Attend: » Regulatory / Compliance Officers » Legal Counsel » Quality / QA / QC » IS / IT

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Presenter: Jeffery J. Scott Vice President, Information Technology Ferndale Laboratories, Inc.

Presenter: Paul Hamby Director Cegedim Dendrite

Moderator: William Looney Editor in Chief Pharmaceutical Executive Magazine

» REGISTER HERE For more information contact Jamie Carpenter - 440.915.7235