Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ
Instructor:
Susanne Manz
Product ID: 705972
- Duration: 90 Min
Why Should You 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. Validation can help you to optimize your processes with resulting improvement in predictability, consistency of outputs and business results.
Areas Covered in the Webinar:
- Purpose, scope, and benefits of process validation
- FDA Expectations, Regulations
- Lessons learned and enforcement case studies
- Common problems and easy solutions
- When to verify and when to validate
- Steps and Checklists for validation
- Linkages within your Quality System
- Master Validation Planning
- Best Practices
- Inspection Preparedness
Who Will Benefit:
- Manufacturing Engineers
- Process Engineers
- Quality Engineers
- Engineering Managers
- Quality Managers
- Auditors
- Compliance Specialists
Susanne Manz
President and Principal Consultant, Manz Consulting Inc
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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
Frequently Asked Questions:
- How are IQ, OQ, and PQ carried out correctly?
- Do you have any references for sampling plans based on statistically valid rationales?
- Why are IQ, OQ, and PQ so important in medical device manufacturing?
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
