Who Should Attend
This two-day course has been designed as an introductory course on the Quality System Regulation (QSR) for medical device and biotech personnel. It will assist those who are responsible for compliance with FDA QSR requirements. The seminar is particularly suitable for professionals responsible for compliance, regulatory affairs, project planning, design and development, technology transfer, QA, R&D and manufacturing. Corporate management will find the course helpful in understanding the legal and system requirements necessary for compliance with the QSR and the penalties for non-compliance.
Upon completion of this course you will have gained the background knowledge necessary to understand and develop QSR compliant programs for your medical device or biotech product. You will have gained insight into how to prioritize QSR implementation at each stage of development and how to assess your progress. You will also learn what the “deliverables” are at each stage of the development process.
This course will introduce you to the Quality System Regulation in the medical devices and biotech industries. Topics covered will include not only the legal requirements for QSR in the Federal Food, Drug, and Cosmetic Act but also how to develop practical applications in order to demonstrate compliance. The faculty consists of individuals with long and distinguished experience in the field.
Throughout this course, the fundamentals of FDA inspections commonly surface. There is special emphasis on discussing procedures and practices of this regulatory agency to help firms comprehend management aspects of FDA inspections.