Preparing for FDA Inspections and Conducting Sponsor Audits


In the regulated pharmaceutical and biotech medical device industries, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the frequency of inspections, it is imperative that everyone involved in the development of new therapies be familiar with government inspection processes and their role during these inspections.

Prerequisites:


Offering code Offering title
CTDM.X411 Good Clinical Practices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X414.(1) 4/6/2018 05:30 PM SANTA CLARA 580 Frances Ann McKenney View Enroll

Regulation of Drugs and Biologics


Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course will help you understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case studies, and hands-on exercises, you'll gain knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, post-marketing requirements, the impact of regulatory differences between U.S.

Prerequisites:


Offering code Offering title
BTEC.X401 Drug Development Process

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X403.(2) 4/10/2018 06:00 PM SANTA CLARA 825 Sheldon L Mullins View Enroll

Mobile Health: The Evolving Industry and Regulatory Landscape


This interactive course provides a landscape of the evolving mobile health technology sector with an explanation of the equally dynamic framework created by U.S. regulatory authorities that oversee this transforming area. Emerging mobile health needs are met with the development of technological solutions enabling new models of delivery of care services and information. The new technologies span the entire lifecycle of care from wellness to chronic disease management and end-of-life care.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485
MEDD.X400 Design Control for Medical Devices

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

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

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.(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

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