This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects.
This presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing 'cloud'-based software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples.
The focus will be on the most recent issues the FDA has had in this area, and remediation approaches. Software considered include: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS/21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing 'cloud' environment.
Why Should You Attend:
Software and related hardware design, development, verification and validation is difficult to manage, document and control.This presentation focuses on the verification and validation planning and execution of software after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and growing 'cloud'-based software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples.
The focus will be on the most recent issues the FDA has had in this area, and remediation approaches. Software considered include: 1) In-product, 2) As-product, 3) Production and test, and 4) QMS/21 CFR Pt. 11. Field examples, good and bad will be addressed. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing 'cloud' environment.
Areas Covered in the Seminar:
- Recent industry failures.
- Tougher FDA Expectations/Requirements.
- Roles of Verification and Validation.
- An FDA 'Model'.
- A Typical Software V&V Protocol/Test Report.
- A Brief Overview of 21 CFR Part 11.
- Legacy, Hybrid, New and ER/ES Systems.
- Expected Regulatory Deliverables.
- Complementary Guidelines, e.g., GAMP.
Who Will Benefit:
This information applies to personnel/companies in the Pharmaceutical, Medical Device, Diagnostic, Neutraceutical and Biologics fields. The employees who will benefit include:- Senior management
- Regulatory affairs
- Quality Assurance
- Production/QAE
- Engineering, R&D, and software development and testing teams
- All personnel involved in a U.S. FDA-regulated environment. Especially those involved in new product development with products and equipment that are software driven, companies with quality management/MRP/ERP systems moving toward 'paperless' systems, or other regulated medical products activities.
Course Provider
John E Lincoln,
