Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
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.
Areas Covered in the Webinar:
• What do IQ, OQ, and PQ stand for?
• Goal of IQ, OQ and PQ for Medical Device Manufacturing Processes
• What are the objectives of the IOPQ protocol
• What is Installation Qualification (IQ)?
• What is an IQ Work Flow
• How is the IOPQ reviewed and signed off on
• IQ touches on many tangible and intangible aspects related to installation –examples
• Creating IQ SOP and Checklist
• With IQ Complete, It’s Time to Conduct the Medical Device OQ Process
• Rrocedures required to verify specific dynamic attributes of the new or modified process
• The Completion of OQ Leads to Performance Qualification (PQ)
• Elements of a PQ Protocol
• Contents of the PQ Report
• Final Step: Understanding When to Revalidate
o When your healthcare setting is used to working in its old ways, it can be a daunting experience trying to plan out a new addition to the workflow. Let’s make it easier to understand and implement.,
• The Role of the Technology Device
• Ease It into the Workflow
• What Is Medical 3D Printing—and How Is it Regulated?
• 3D printing and how is it used in health care?
• Challenges for FDA oversight
Who Will Benefit:
• Manufacturing Engineers
• Process Engineers
• Quality Engineers
• Engineering Managers
• Quality Managers
• Compliance Specialists
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
Dr. Michael C. Redmond, PhD, is a certified project manager, PMP, has two master certifications in business continuity/disaster recovery MBCP and FBCI and is certified in emergency management. She is active in cyber security and holds multiple ISO certifications (ISO/IEC 27001 Information Security Management, ISO/IEC 27032 Lead Cyber Security Manger, ISO/IEC 27035 Security Incident Response, ISO/IEC 22301 Business Continuity Management Systems, ISO/IEC 21500 Project Management, and ISO/IEC 41001 Environmental Management). She is an international consultant, speaker and published author.
Michael's MBA in Risk Management included courses in Information Security and Risk Management for Medical Devices and Healthcare. Michael is certified as a Senior Lead Manager in Information Security for Healthcare ISO 27999.As a practitioner, she has been implementing ISO 27999 and ISO 14971 for over 10 years for clients.
Her past experience includes 13 years as a senior manager with Deloitte, KPMG and Chubb in the areas of: compliance, crisis management, business continuity, disaster recovery, emergency management, internal audit/ gap analysis. She was a business continuity/disaster recovery manager with the Bank of New York. She consults for clients in diverse industries such as banking, manufacturing, pharmaceutical, hospitals, government agencies, colleges and universities, law firms, and media.
Dr. Redmond spent 4 years on active duty with the army and 18 1/2 years as National Guard and Reserve before retiring as a major. She is a graduate of Command & General Staff College (Fort Leavenworth), attended civil affairs courses at the US Army JFK School of Special Warfare and is Hazmat trained and DOD certified. The White House honored Dr. Redmond at a luncheon as one of the Top Women in Her Field of Business Continuity.