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

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.(4) 9/6/2018 06:00 PM SANTA CLARA $765 Edward James Rozhon Enroll
BTEC.X401.(5) 1/17/2019 06:00 PM SANTA CLARA $765 Edward James Rozhon 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.(2) 1/16/2019 06:00 PM SANTA CLARA $800 Mary E McDonald Enroll

Drug Quality Fundamentals: Quality Control of Small Molecule Drugs and Biologics


This introductory course provides an overview of key drug quality concepts and standards for the pharmaceutical and biotechnology industries. Interactive lectures explore quality system and control process best practices in clinical development, drug manufacturing and for commercial products. You'll learn the roles and responsibilities of quality assurance (QA) and quality control (QC) in ensuring the safety, efficacy and quality of drug products. You'll contrast specific quality attributes of large-molecule recombinant biological products with those of small molecule drugs.

Prerequisites :


Offering code Offering title
BTEC.X401 Drug Development Process
REGL.X400 Good Manufacturing Practices
REGL.X403 Regulation of Drugs and Biologics

Global Medical Device Submissions and Strategy


The global nature of the medical device industry presents both opportunities and challenges for medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the EU, Canada, Japan, China and Brazil.

Prerequisites :


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

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X401.(3) 9/8/2018 08:30 AM SANTA CLARA $750 Patrick Lee 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.(3) 9/24/2018 06:00 PM SANTA CLARA $825 Sheldon L Mullins 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

Good Manufacturing Practices


Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations.

Prerequisites :


No prerequisites


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.(2) 9/26/2018 06:00 PM SANTA CLARA $700 Michelle A Carpenter Enroll
REGL.X402.(3) 2/11/2019 06:00 PM SANTA CLARA $700 Michelle A Carpenter 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


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