Dates: August 10-12, 2021, 8:00AM - 5:00PM ET
About the Series
Process Validation Requirements & Industry Practices is a 3-day, virtual training that will provide attendees with practical tools and techniques for process validation requirements to meet FDA’s Quality System Regulation, the ISO 13485:2016 Standard, and recognized Process Validation Guidance from the Global Harmonization Task Force. The program will feature industry best practices and real-life process validation examples to guide attendees through the process.
Attendees have the option to demonstrate their learning and justify employer investment by completing and passing the Process Validation post-course test. This optional, one-hour, self-assessment tests your mastery of the course materials and your ability to correctly interpret the Quality System Regulation and the ISO 13485 Standard.
Meet the Faculty
Founder, AJW Technology Consultants, Inc.
FDA and AAMI faculty work together to help the learner to:
- Determine which processes require validation and develop a Validation Master Plan
- Develop protocol content to ensure a successful validation
- Document the results and the resolution of deviations that occur during validation execution
- Plan for effectively monitors and controls for their validated processes
- Determine the revalidation requirements for product and process changes
- Planning, Protocol Development, Validation Execution, Monitoring & Control and Revalidation to meet the FDA’s expectation and industry’s best practices
Who Should Attend?
Instruction is geared to professionals involved with process validation in the medical device industry such as Manufacturing Leads, R&D Team Members, Quality Engineers, Quality Assurance Managers, Design Engineers, Project/Program Managers, and Manufacturing/Process Engineers. To maximize the peer learning opportunity, AAMI recommends this course for those who already have a basic understanding of the Quality System regulation and have some relevant work experience.
Meet your instructor:
Art Ward, Ph.D., MBA, BSEE is the Founder of AJW Technology Consultants, Inc. His firm provides global regulatory, quality systems and technical support for medical manufacturing and development companies. Dr. Ward began his career as an engineer for a major medical optics firm. He then progressed into manufacturing and quality, becoming a Plant and Division Manager for a blood systems manufacturing company. Prior to starting his own consulting firm, Dr. Ward was Vice President of RA/QA for an anesthesia and respiratory products company and he was also responsible for Field Engineers and Service Centers. He has design control and validation experience with many medical products including software controlled devices. With 40 years of expertise in the medical field, his experience with quality systems has aided many firms achieve ISO Certification and FDA Compliance. His background includes engineering, manufacturing, quality and regulatory responsibilities. He also serves as an Expert Witness for FDA in potential litigation cases.
Virtual Training Information
Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email firstname.lastname@example.org.