Effective Hazard Analysis and Design Control for FDA and ISO 13485 Compliance: Pack of Two Courses
From Medical Devices
This pack of two training courses provides 2 hours of training on analysis of the sections of the QSR design control regulations.
This pack of two training courses provides 2 hours of training on analysis of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard & How to make the Hazard Analysis process work for you to create value (it has) for the entire life cycle of your product design and process development efforts.
Module 1: Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation
Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue. This presentation will review the sections of the QS Reg.design control regulation which have requirements not present in the ISO 13485:2003 standard. Actual design control/FDA data will be discussed, which shows the agencies' design control compliance directions. FDA investigator techniques will also be discussed.
What Attendees will Learn:
What are the key differences between design control rules of the QS Reg. and the ISO 13485:2003 standard, QSIT design control audit process, How do I counteract a possible FDA 483 cite, Where does risk management fit in, How do I correct the FDA compliance gaps in my design control process, Should I create one quality system which complies to both rules, How do I better audit my design control system, How do I train my staff in design control compliance, How do I answer an FDA 483 cite to FDA, How do I improve my design control Internal audit process, What type of resource commitment is there achieve dual compliance
Instructor Profile:Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts.
Module 2:How to do an Effective Hazard Analysis to meet FDA and ISO13485:2003 risk management requirements
This presentation will show you how to make the Hazard Analysis process work for you, what value it has for the entire life cycle of your product and how to use the process to help focus your design and process development efforts to target the most critical aspects of the product's intended use, helping you deliver a safer, higher quality product to your customers.
What Attendees will Learn:
Why Hazard Analyses are required (and useful) ,How to use a Hazard Analysis to prioritize opportunities to increase safety, Quantitative vs. Qualitative Approach,Clarification of the terms Hazard, Hazardous Event and Hazardous Situation, The common mistakes in determining occurrence and severity rankings, What you can and cannot affect to reduce your risk to an ALARP (as low as reasonably possible) level, Determining a risk threshold, Revising and updating your Hazard Analyses.
Instructor Profile :Robert DiNitto is a principal and one of the founders of AlvaMed, LLC, an innovative medical technology consulting firm. He leads AlvaMed’s QA/RA and Design Control practice, having over 35 years of experience in the medical device industry. Bob has developed and implemented design control systems that have been well received by both engineering organizations and regulatory auditors, and received a high approval rating from an FDA auditor. His engineering experience, in roles ranging from project engineer to VP of R&D, covers many types of products from small, portable monitors with sterile disposables to large x-ray systems.