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.
Why Should You Attend:Both the U.S.
FDA and the
EU`s MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MS-Excel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What does "science-based" mean? What V&V (
verification and validation) planning steps are expected under the
CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does
ISO 14971, ICH Q9, and similar risk management systems come in?
This excel and word document validation webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes, in a realistic, risk-based approach.
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
