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


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

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X405.(2) 9/20/2018 06:00 PM SANTA CLARA 860 Craig Coombs View Enroll

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


Regulatory Submissions: Drugs and Biologics


Submissions to a regulatory agency such as the FDA involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with regulations, guidance documents and style guides to produce submissions that comply with the requirements and are clear to the reviewers.

Prerequisites:


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

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X406.(1) 7/12/2018 06:00 PM SANTA CLARA 860 Romi Behbehanian View Enroll

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


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X400.(2) 7/21/2018 08:00 AM SANTA CLARA 825 Larry S Wigman View Enroll

Quality Systems for Medical Devices: FDA QSR and ISO 13485


Through a series of lectures, interactive discussions and case studies, this course provides in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. The course emphasizes using the principles of the medical device quality system (QS) regulations and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today's dynamic regulatory environment.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X407.(3) 9/25/2018 06:15 PM SANTA CLARA 800 Kiran Gulati View 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

Good Clinical Practices


Clinical research is governed by a set of broad regulatory requirements, industry standards and recommendations. Interpreting and implementing these “best practice” standards presents a challenge for all the stakeholders involved in human research. This course explores the framework and principles of Good Clinical Practice (GCP) as it relates to the roles and responsibilities of various stakeholders like the FDA, Investigator, Sponsor, IRB and the study subject.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
CTDM.X411.(3) 10/3/2018 06:00 PM SANTA CLARA 800 Narinder Singh View Enroll

Post-Market Regulatory Obligations for Medical Devices


Once medical devices are on the market, manufacturers are required to follow specific requirements and regulations. This includes investigating complaints, submitting to the FDA's eMDR system for reporting device malfunctions, injuries or deaths; handling recalls, managing post-market surveillance studies requirements under section 522 of the Federal Food, Drug and Cosmetic Act, as well as post-approval studies required at the time of approval of a premarket approval (PMA); and handling advertising and promotional labeling.

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
MEDD.X406.(2) 11/10/2018 08:30 AM SANTA CLARA 750 Clarisa A Tate View Enroll

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 View Enroll

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