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ComplianceOnline, Online Event
2012-08-21
Why Should You Attend: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system. This webinar will help you develop or refine the company Master Validation Plan to meet FDA / cGMP expectations. It will address the FDA's newer and tougher regulatory stance. Areas Covered in the Seminar: - Process Validation -- New regulatory expectations.
- Adjusting the Master Validation Plan.
- Product, Process / Equipment V&V.
- When and How to Use DQ, IQ, OQ, PQ.
- Using the Risk Management tools of ISO 14971 and ICH Q9.
- The 11 Elements of the Software VT&V "Model".
- Avoid recent "horror stories" and multimillion dollar fines.
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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 software 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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2012-08-20
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Registration:
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For Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701662?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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