The seminar starts with an understanding of the regulations through a variety of sources. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT) and then turns to Warning Letters to help understand the issues.
Learn the sections of FDA QSR that require statistical techniques.
Understand how to apply the FDA tools to develop a clear understanding of the requirements.
Small Entity Compliance Guide
Understand the set of statistical techniques in ISO/TR 10017
Learn how to implement and apply the ISO/TR 10017 statistical techniques.
Who will Benefit:
All medical device manufacturers that apply FDA QSR or ISO 13485:2003:
Quality Assurance and Quality Control
Regulatory Affairs Managers
Regulatory Affairs Professionals
Product Design and Development
Production Managers and Supervisors
Complaint system team members
CAPA team members
Dan O'LearyPresident at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
For Registration - https://www.complianceonline.com/statistical-techniques-for-medical-device-manufacturers-seminar-training-80098SEM-prdsm?channel=eventbrite
Note: Use coupon code REFERRAL10 and get 10% off on registration.