This validation training will discuss FDA impacts and approaches for compliance for use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing.
Areas Covered in the Seminar:

• Tougher FDA and EU MDD Software V&V Expectations.
• Key COTS Software Apps V&V Requirements .
• Problem Areas.
• Product, Equipment/Process, QMS and Apps Software and Part 11 Requirements .
• Realistic Limits of Apps Software V&V .
• Suggested Approaches.
• How to Implement, Execute and Document.
• Proper Risk Allocation of Scarce Resources.

Who Will Benefit:
This webinar will provide valuable assistance to personnel in all regulated companies responsible for software validation under the cGMPs and EU MDD/CE-marking. This information applies to personnel / companies in the FDA-regulated industries, e.g., Devices, Pharmaceutical, Diagnostic, Biologics and Dietary Supplements. The employees who will benefit include:

• Senior management
• Regulatory affairs
• Quality Assurance / QAE
• Production
• Software Implementers
• Engineering
• Sales and Marketing
• All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD -regulated environment

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