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
- All personnel involved in a U.S. FDA- and/or EU ISO 13485/MDD-regulated environment
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and so+E6ftware validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
Topic Back ground:
V&V of apps software is an important step in meeting tougher FDA requirements. Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. It is very much essential to know how does that impact companies' use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing? How can this be addressed? What does "science-based" mean? What are current 483 and Warning Letters indicating, and what can we learn from these? What benefits beside regulatory compliance can be achieved for a company? It is essential for all companies to know the current climate, understand where it can go wrong. It is essential to identify the areas and flag it beforehand so that necessary rectification steps can be taken. One more important factor is how to allocate resources which plays a major role in V & V planning.
