ICH Quality Guidelines: Intent and Overview


Consider what it takes to create a safe, effective, high quality pharmaceutical product that complies with global International Conference on Harmonization (ICH) Quality Guidelines. In this course, students review each guideline pertinent to drug development, patient safety, health authority review, and commercial manufacturing. This uniquely robust overview provides an understanding of the regulatory intent, helping to prepare professionals for competitive job roles in San Francisco Bay Area biopharma.

Prerequisites:


No prerequisites


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) 10/1/2018 06:00 PM SANTA CLARA 825 Sheldon L Mullins 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

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

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


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

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


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) 7/25/2018 06:00 PM SANTA CLARA 860 Romi Behbehanian View Enroll

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

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