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ComplianceOnline, Online Event
2011-02-22
NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. Why Should You Attend: Software and related hardware design, development, verification and validation is difficult to manage, document and control. Where as Software design and development is under increased scrutiny by the new "tougher" U.S. FDA. This is with good reason. Product, production / test equipment, and even the QMS are increasingly software / firmware driven. 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) software. A suggested FDA model will be evaluated, implemented, with V&V documentation and test case examples. The focus 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 / Pt. 11. Field examples, good and bad will be addressed. We will evaluate the chief areas of FDA concerns to see actual and anticipated changes in emphasis based on this new regulatory climate. Areas Covered in the Seminar: - Discussion on 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 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 and past problems. 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. This information applies to personnel / companies in the Pharmaceutical, Medical Device, Diagnostic, Nutraceuticals and Biologics fields. The employees who will benefit include: - Senior management
- Regulatory affairs
- Quality Assurance / QAE
- Production
- Engineering, R&D, and software development and testing teams
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2011-02-22
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Registration:
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Attend Live Online Training | $295.00 One Dial-in One Attendee |
$1,095.00 Group–Max. 10 Attendees
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E-mail:
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admin@complianceonline.com
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