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Submission: On November 29 via manual from IN — Scanned from DE
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Submission: On November 29 via manual from IN — Scanned from DE
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Text Content
PanelCompliance Knowledge. Creativity. Performance * Category * Medical Device (ISO 13485) * Drugs / Biologics * FDA Compliance * Food & Beverages * Quality Management (ISO 9001) * OSHA Compliance * IT Security * Sox Compliance * Clinical Compliance * Auditing/Accounting & Tax * Banking & Insurance * Geology and Mining * Risk Management * Project Management * Intellectual Property Law * Excel Spreadsheet Techniques * FAA Compliance * Trade & Logistics * Retail * Environmental Compliance Cart 0 Sign In Sign Up Cart 0 * Home * About Us * Live Webinars * Recorded Webinars * Products/E-Books ESSENTIALS OF VALIDATION - IQ OQ PQ * Wednesday Time: 10:00 AM PST | 01:00 PM EST Duration: 90 Minutes Instructor: Susanne Manz Webinar Id: 51730 More Trainings by this Expert Price Details $149 Live $299 Corporate Live $199 Recorded $399 Corporate Recorded Combo Offers Live + Recorded $299 $348 Live + Recorded Corporate (Live + Recorded) $599 $698 Corporate (Live + Recorded) Refund Policy Price Detail Options Live: One Dial-in One Attendee Corporate Live: Any number of participants Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Overview: Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements and the essentials of validation. You'll learn about what processes need to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management. We'll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices. Why you should Attend: Failure to validate is a significant cause of 483 observations. Even worse, it can result in customer complaints, adverse events, and even recalls. In this webinar, you'll learn how to avoid these problems and use validation concepts to ensure process stability and control. You'll learn the benefits and impacts of validation and how it can benefit your customers and your business. We'll cover tools and techniques that can help you successfully validate your processes. Areas Covered in the Session: * Purpose, scope, and benefits of process validation * FDA Expectations, Regulations * Lessons learned and enforcement case studies * Common problems * When to verify and when to validate * Process and steps for validation * Linkages to your Quality System * Master Validation Planning * Best Practices Who Will Benefit: * Manufacturing Engineers * Process Engineers * Quality Engineers * Engineering Managers * Quality Managers * Auditors * Compliance Specialists Speaker Profile Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. View More Trainings by this Speaker YOU RECENTLY VIEWED Essentials of Validation - IQ OQ PQ by : Susanne Manz Date : Wednesday, 30. November 2022 10:00 AM PST | 01:00 PM EST Duration : 90 Minutes Price : 149,00 $ View Details PanelCompliance 39658 Mission Boulevard, Fremont, CA 94539, USA. +1-800-447-9407 Fax: 302 288 6884 support@PanelCompliance.com LINKS About Us Contact Us Privacy Policy Refund Policy Terms & Conditions FAQ Support Featured Speakers Speaker Opportunity Suggest a Topic Unsubscribe RSSFeed NEWSLETTER Subscribe for Compliance Alerts Research Reports Absolutely Free Subscribe SAFE & SECURE Copyright © 2022 PanelCompliance. All rights reserved.