Regulation of Medical Devices and Diagnostics


What's the origin story of a medical device? Medical devices encompass a broad array of products, ranging from the tongue depressor to surgically implanted stents and pacemakers. This course provides individuals from all backgrounds with a solid grounding in the laws, regulations and institutions that underlie the process of medical device and diagnostic product development and marketing.


The instructor first defines medical devices, provides an overview of the medical device industry and the historical roots of medical device regulation.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X404.(1) 1/16/2018 06:00 PM SANTA CLARA 825 Clarisa A Tate View Enroll

Validating Software for Medical Devices and Emerging Technologies


With the increasing number of medical devices running on software, there is an enormous demand for quality assurance and regulatory affairs professionals who can address the validation, documentation, compliance and submission requirements unique to software-controlled devices.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics
MEDD.X400 Design Control for Medical Devices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X410.(1) 1/22/2018 06:00 PM SANTA CLARA 800 Mary Beth McDonald View Enroll

Interacting with the FDA


Regulatory affairs professionals interact with the U.S. Food and Drug Administration (FDA) throughout the life cycle of a biomedical product. Lectures, case studies and roleplaying are used to explore the range of interactions that industry has with the FDA, including inspections and key meetings. Students learn how to prepare for these important events.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X402.(1) 3/7/2018 06:00 PM SANTA CLARA 700 Michelle A Carpenter View Enroll

Value-Added Quality Audits


In today's dynamic business environment, every aspect of an organization needs to perform value-added activities that have a positive impact on the bottom line. Regulatory and quality units in more and more biomedical industry corporations are relying on quality audits as a means to improve operations. By auditing to domestic and international quality system regulations (GXP, QSR and ISO), these organizations are assessing and improving the effectiveness of their internal systems and those of their suppliers and corporate partners.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X407.(1) 4/28/2018 08:30 AM SANTA CLARA 700 Kiran Gulati View Enroll

Drug Development Process


The development of new drugs is a highly complex, lengthy and expensive process. In this course, you examine this process---from discovery to market and beyond---and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures will address drug discovery; preclinical characterization of new drug entities; the phases and purposes of both pharmacological and clinical development; regulatory filings, compliance and oversight; FDA jurisdiction; and strategic issues in drug development.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
BTEC.X401.(2) 1/18/2018 06:00 PM SANTA CLARA 765 Edward James Rozhon View Enroll
BTEC.X401.(3) 4/12/2018 06:00 PM SANTA CLARA 765 Edward James Rozhon View Enroll

Data Privacy and Security for Healthcare and Biosciences


Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.

Prerequisites:


No prerequisites


Design Control for Medical Devices


The successful development of medical devices requires that the design be controlled to ensure product safety and that the device can fulfill its intended use. This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality. You'll learn to use the nine elements of design control to make design objectives clearer, products more testable, and to better satisfy customer requirements, thereby shortening the path to product and business success.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X400.(1) 2/3/2018 10:00 AM SANTA CLARA 800 Farhan Shahab View Enroll

Clinical Trials Essentials: An Intensive One-Week Course


Well-planned and well-executed clinical trials are the cornerstones of effective drug and medical device development. Offered in an accelerated format and taught by leaders in the biopharmaceutical industry, this course provides a unique opportunity for professionals from all disciplines to learn about the many facets of clinical trials--the complex process that ensures the safety and effectiveness of medical products.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X801.(1) 3/12/2018 08:30 AM SANTA CLARA 1865 Gerald Peter Shabe View Enroll

Regulatory Submissions: Devices and Diagnostics


This course is designed to provide individuals with pragmatic knowledge of how to craft medical device submissions for approval by the FDA. Students should already have a foundation in medical device terminology, classification, and regulations prior to taking this course. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with the regulations, guidance documents, and style guides to write portions of key medical device submissions that both comply with the requirements and are clear to the reviewers.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics

Medical Device Marketing


Are you interested in making the leap from regulatory zero to marketing hero? The key to building a successful medical device business is finding balance between meeting regulatory requirements and maximizing marketing opportunities. It is critical that life science professionals understand the role of regulatory affairs and its impact on revenue generation. This course uses case studies (e.g.

Prerequisites:


No prerequisites


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