OTech, Inc.

On / Off Site & OTech

IHE

Locations / Pricing

Regulatory Services

Regulatory Training Course
November 25
Chicago

Who Should Attend

Seminar Contents

OTech Seminar
	You will gain a thorough understanding of FDA regulations as they relate to Picture Achieving and Communications Systems (PACS) for medical devices. You will learn what FDA regulatory requirements must be met for a PACS 510(k), when a change or modification to an existing PACS device will require you to submit a new 510(k), and how to determine substantial equivalence. In addition to 510(k) regulations, you will understand what to do for an internal audit, what the mandatory FDA requirements for Good Manufacturing Practices (GMPS) are, their content, and how they are interpreted by the FDA for computer controlled and PACS medical device manufacturing.

Who Should Attend:
Anyone who wants to learn about 510(k) submissions for PACS devices and FDA Good Manufacturing Practices, ranging from individuals who deal with regulations on a high level such as development managers and manufacturing supervisors to regulatory affairs and quality assurance people who want in-depth knowledge of the regulations.


Locations:
Chicago: Sunday November 25 during RSNA or at your own location (on-site training)


Course Hours:
From 9:00 a.m. - 4:30 p.m. Your instructor is also available during lunch for informal discussions about your specific area of interest.


Course Tuition:
The course tuition is $395 for one day. It includes class participation, handouts of the slides (the ones that are not copyright protected), morning and afternoon refreshments, a simple lunch.


Payment Method:
Payment can be made by check or AMEX-VISA/Mastercard upon arrival, or with a PO. 10% Multiple enrollment discount will be offered when two or more people from the same organization enroll together for the same location.


Seminar Content:
Introduction Seminar Objectives. Medical device regulation history. FDA definition of a PACS medical device. 5 Steps to FDA compliance for PACS devices. 510(k) Premarket Notification 510(k) PACS program overview. Determining your need for an initial 510(k). Determining Substantial Equivalence. General content of a 510(k). Device Modifications Deciding when a modification mandates a new 510(k). What precautions to take if you decide a new 510(k) is not needed. Good Manufacturing Practices for Software Devices Overview of FDA GMP regulations Global Harmonization and the new GMPs Key areas of your Quality System Responsibility Corrective Action Validation and verification Internal Audits Control of equipment and software Manufacturing software control and documentation. Calibration and software tools Identification Software changes and validation Device Labeling and software error messages Finished device inspection Failure investigations Device Master Records Device History Records Complaint Files Medical Device Reporting (MDRs) Internal Audits