ComplianceOnline, Online Event
2012-10-16
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.
Event Details: Date: October 16, 2012 Time: 10:00 AM-11:30 AM PDT Cost: $299 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart. |
|
|
Invited Speakers:
|
|
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 years as a full-time consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.
|
|