Risk Management for Regulated Industries


This course discusses how risk management is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and workshops delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System.

Prerequisites:


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

Regulation of in vitro Diagnostics in Europe and the US


This course offers a comprehensive overview of the current European and U.S. Regulatory and Quality Affairs for in vitro diagnostic (IVD) products. You will gain a perspective on the critical elements of the regulatory requirements for obtaining IVD marketing approval. This course will take an extensive look into specific in vitro diagnostics topics and learn about the new and emerging regulatory requirements surrounding them.

Prerequisites:


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

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

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

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

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


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


Human Factors and Usability in Medical Device Development


Understanding and applying human factors is essential to ensuring product usability and user satisfaction. More importantly, consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation each week to cover core concepts and demonstrate how human factors fit into the larger context of medical device software and hardware development.

Prerequisites:


No prerequisites


Medical Device Verification and Validation


Verification and validation is the process of determining whether a medical device and its manufacturing process meets design input requirements and ensures that devices conform to defined user needs and intended uses. It answers the questions, "Are you building the right safe and effective device?" and "Are you building it right?"


One of the most common reasons that ISO auditors and the FDA issue warning letters is because they notice an inadequate verification and validation—or a complete lack thereof.

Prerequisites:


No prerequisites


Mobile Medical Applications


A growing number of health-related software applications are being developed for use on mobile platforms, including smartphones and tablet computers. These applications are creating new and innovative ways for technology to improve health and health care. Consumers are using mobile medical applications to manage their own health and wellness and health care professionals are using applications to improve and facilitate patient care.




Developers of mobile medical apps and other medical devices professionals may be unsure about how or if FDA regulations apply to their products.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X405.(1) 1/26/2018 09:00 AM SANTA CLARA 385 Bharat (Bill) C Kurani View Enroll

Pages