Medical Product Development

From concept through development to approval, the medical product life cycle integrates medical product design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Product Life Cycle in order to manage projects and multifunctional product teams. Topics covered include: quality function deployment, conjoint analysis, benchmarking, computer design and prototyping, failure modes and effects analysis, computational fluid dynamics, intellectual property, financial analysis, and statistical methods. Guest experts and case studies augment the learning experience.

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.

This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; pharmaceutical industry requirements; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); FDA inspections, labeling, and advertising of medical products; and preparing Food and Drug Administration (FDA) submissions.

Learn about the essential elements of Quality System Regulations (QSR's) and Good Manufacturing Practices (GMP's), how there is a commonality between them, and how to develop a global approach to Quality Systems in order to satisfy international requirements of ISO 9001:2000 and ISO 13485:2003. A detailed analysis of these systems and practical 'how to' recommendations and approaches are presented, with particular emphasis on the United States Food and Drug Administration (FDA) QSR's and GMP's.

Getting your medical product to market successfully starts before product design and does not end with the product launch. This course focuses on what is needed to successfully market products within medical device and related industries. Learn how to analyze the market, identify and understand customers and users in medical marketing industries, and provide them with value through innovation, sales and service. Case studies and insights from practicing medical product professionals enhance the application of classroom concepts.

Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research environment; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process.

Increase your knowledge of business and legal issues in the biomedical industry. Participants will learn to discern the rationale behind policies and procedures in a highly regulated industry. A top down approach is taken to introduce broad business and legal concepts and relating them specifically to design, development, and commercialization of medical device and pharmaceutical products. Topics include: corporate structure, corporate formation; and early stage financing, contracts, licensing, intellectual property, due diligence and sale.

Learn about the essential manufacturing principles for medical device and pharmaceutical products, and the regulations governing the medical product manufacturing process. Gain valuable knowledge in understanding the key principles, challenges and issues involved in good manufacturing practices (GMPs) of medical products. Topics include: product development cycle, understanding the customer and their needs, material and process selection, packaging and sterilization, reliability testing, design validation, manufacturing process validation, and developing a manufacturing strategy.

Enhance your understanding of process validation and how it is applied to the development of medical products. Learn how to assess an appropriate level of process scrutiny to provide a high level of confidence for process validation. Increase your knowledge of validation project management; basic approach to process validation; validation criteria for facilities and utilities; sterilization; controls, automated processes, and computer systems. Case studies illustrate how critical processes are validated in the development of cardiovascular, ophthalmic, and intravenous devices.

Learn to use Design of Experiments (DOE) to dramatically improve product and process innovation, effectiveness, and efficiency. DOE is the scientific approach used by researchers to build empirical mathematical models of product and process performance. These models are formulas that can be used to optimize product and process performance while significantly reducing costs. This software-based course provides practical hands-on training covering basic and advanced DOE methodology. Learn how to: create 1st and 2nd order empirical product and process models; use these models and Response Surface Methodology (RSM) to optimize product and process performance; reduce variation and increase robustness of product and process performance by using Residual Analysis, RSM, and Dual Response Analysis; and much more.

Get the facts you need about ISO 14971:2000 - a harmonized standard for Medical Device Directive 93/42/EEC for the European Union (EU), and a recognized consensus standard for the U.S. Food and Drug Administration (FDA). Increase your understanding of the risk management principles, standards, and regulations involved in medical device development. A step by step guidance will help you achieve an understanding of ISO 14971 so that you can implement and effectively use this complex standard.

Clinical trials are designed to answer questions concerning the safety and effectiveness of medical products. Get an overview of clinical trials regulated by the FDA. Learn about the planning process underlying the Strategic Clinical Plan and regulatory submissions to the FDA. Explore topics including protocol development and implementation, i.e. study site selection, financial controls, timelines, and management of the site's operations; proper informed consent; Good Clinical Practices compliance; HIPAA; FDA regulations and guidelines; and post-market support studies.

Gain the knowledge to understand and comply with FDA Good Laboratory Practice (GLP) regulations for the conduct of animal/in vitro safety studies. Enhance your understanding of topics including: regulations from the Code of Federal Regulations (CFRs), European and Japanese regulations, typical methods of compliance, how GLP fits into the drug/device/biologic development process, and ethics regarding animal care. Learn about sponsor obligations and how to evaluate a contract laboratory. Visit a clinical research center to reinforce the importance of GLP guidelines and compliance.

Chemistry, Manufacturing, and Controls (CMC) constitutes that part of the pharmaceutical developmental process that deals specifically with the physical nature of the drug substance and the drug product, the manner in which both are made, and the manner by which the manufacturing process is shown to be in control, that is, reliable and reproducible. Increase your understanding of the CMC process to ensure that the final drug product meets the stringent requirements under the law for identity, purity, and potency. Participants explore each separate part of CMC and relate them together through the study of the Common Technical Document (CTD). This includes regulatory requirements for IND's, IMPD's, NDA's, MAA's, and annual supplements.

Increase your understanding of globally distributed product development strategies and gain insights on how your organization can address today's outsourcing and manufacturing challenges. This course focuses on familiarizing the participant with the globally distributed product development environment. Participants will further their knowledge on strategies to reduce R&D costs and time to market. An emphasis is placed on identifying cost effective solutions for most complex manufacturing requirements. Topics include: business context and drivers for creating outsourced relationships; vendor selection and evaluation; relationship life cycle management; identifying frameworks for distributed teams; planning and building captive development centers; and tools for collaborative engineering.

Expand your knowledge on how to ensure compliance of your firm to the FDA regulatory standards. This course will enable you to increase your understanding of medical device and pharmaceutical product compliance activities within your organization and the industry in general. Through a case study approach, this course analyzes the different types of FDA regulatory sanctions with emphasis on FDA 483, and Warning letters. Through this case study approach students will also learn the method and mannerism of response to the FDA 483, Warning letters as well as the development of corrective actions. An emphasis is also placed on the common industry compliance activities such as preparing for an FDA inspection (CGMP, PAI), hosting, and interaction.

Whether designing investigational drugs and medical devices or conducting clinical trials, it is important to have a basic understanding of the form and function of the human body. Learn about human anatomy and physiology as related to pharmaceuticals and medical device design for clinical studies. Clinical examples and modeling techniques are used to demonstrate the applications of anatomy and physiology in the development of investigational drugs and medical devices. Course focus is on human safety in clinical studies.

Explore the opportunities and need for medical devices through the examination of mortality and morbidity with special attention to medical problems that affect patients' productivity. A market and need-driven systems engineering approach is applied to the examination of medical device design. The designs of medical devices are then studied through a layered approach of examining the underlying physiological mechanisms, the applicable biomedical sensors and actuators as well as the control processing power requirements. Exemplary medical device solutions are studied.

Further your understanding of FDA regulatory requirements and how they relate to appropriate software engineering practices for medical device software development. Gain an understanding of FDA software compliance and learn how to evaluate their key software engineering activities against FDA Quality Systems Regulation (QSR) and FDA software specific guidance documents. This course is of interest to software project managers, software developers, software test engineers, quality assurance professionals, regulatory affairs professionals, and individuals interested in working in the medical device software development industry.