Overview: 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 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 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.
Why should you attend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded.
- 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?
Areas Covered in the Session: - 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: - Senior management in Drugs, Devices, Biologics, Dietary Supplements
- QA
- RA
- R&D
- Engineering
- Production
- Operations
- Consultants
