A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records/signature V&V as well. This training program 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. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
A suggested field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 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.
Why Should You Attend:
Software and related hardware design, development, verification and validation is difficult to manage, document and control. This presentation will focus on the documentation required by the U.S. FDA for 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 field-tested 11-element FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus of the webcast is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 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.
Areas Covered in the Webinar:
- Major industry failures
- Tougher FDA expectations/requirements
- Roles of verification and validation
- The 11-element FDA model - and where it's required
- A typical software V&V protocol/test report
- A brief overview of 21 CFR Part 11, ER/ES
- Legacy, hybrid, new, and cloud systems
- Expected regulatory deliverables
- Complementary guidelines, e.g., GAMP
Who Will Benefit:
This information applies to personnel/companies in the pharmaceutical, medical device, diagnostic, nutraceutical and biologics fields. Employees who will benefit include:- Senior management
- Regulatory affairs
- Quality assurance/QAE
- Production
- Engineering
- R&D
- Software development and testing teams
- All personnel involved in a U.S. FDA-regulated environment
- 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
Speaker
John E LincolnCourse Provider
John E Lincoln,
