Biocompass Advancing Industry with Education

Life Sciences Courses

California State University offers a variety of courses in project management, quality assurance as well as entrepreneurship and business management to help small business owners start, manage and grow their businesses.

Cal Poly Pomona

Project Management for Business Professionals
The course aims to develop the range of business and interpersonal skills and project management techniques required to manage today’s projects. Participants will learn to: increase the skill and confidence to plan and control projects successfully; develop the ability to deliver projects on time and within budget; improve the know-how to identify what a project really requires in time and resources; increase the ability and confidence to communicate and clearly set attainable goals with your clients, managers and project team members; achieve an understanding of what it takes to be a successful project manager; and sidestep the most common project management pitfalls and problems.

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Project Risk Management
Project managers must assess and manage the risks of a project in order to ensure a favorable outcome. This course will help participants better understand the critical risks facing projects, before and during the project. Participants will acquire the skills needed to perform risk analysis, to control multiple risks, and to build a risk response plan using strategies practiced by successful project managers.

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Project Quality Management
Project managers will discover the many benefits of project quality management through this course. This course provides participants the knowledge and skills needed to plan and implement the quality management practices necessary to develop the best product. Emphasizing quality control and quality assurance will ensure the highest product development quality. Participants will also learn about continuous quality improvement.

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Project Cost Management
This Project Cost Management course will take a look at the impacts of poor and unrealistic budgets of a project. It will focus on the financial management aspect of project management, such as evaluating projects based on cost/benefit analysis and developing an organized cost management plan.

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Controlling and Planning a Project
A project manager’s role entails controlling and planning a project throughout the duration of the project. This course will teach participants how to create and execute an effective project management plan. It will explore the tools and techniques used to monitor the progress of a project, identify project discrepancies, and resolve/lessen the impact of a problem.

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Leadership and Team Building in Project Management
To maintain a high-performance project team, a project manager must learn how to be a manager and a leader. This course will teach participants the techniques of communicating with a team, even when there is no direct supervision of the team members.

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Managing Effective Outsourced Projects
In today’s project management environment, it is recognized that part of a project may be outsourced to another company, whether domestic or global. This trend calls on the ability of a project manager to bring together the efforts and schedules of individuals, teams and resources, with geographical and cultural differences. This course will teach participants the best practices and techniques to effectively manage outsourced projects.

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QAS 540 Food & Drug Law
This course is designed to provide a practical interpretation of the Food and Drug laws and interpretations for professionals who are providing products or services in industries regulated by the Food and Drug Administration.

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QAS 541 Biomedical Quality Control Methods
In depth study of quality control disciplines as applied to medical device, pharmaceutical and/or biologics regulated environments.  Topics include influencing discipline and applying models;  methods that monitor, maintain and/or improve product or service quality; operational efficiency.

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QAS 542 Risk Management in FDA Regulated Agencies
Risk Management as applied to FDA-regulated and other industries (product and process-related);  emphasizes application of risk management tools, plan and program from inception of product and process until and including manufacturing process and field experience of the product , process or service.

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Introduction to Six Sigma for Managers
The students of the Introduction to Six Sigma for Managers course will be able to understand and communicate with Green and Black Belts after completion of the course. They will learn critical success factors in the implementation of Six Sigma within their organization. They will also learn the strategies and benefits of Six Sigma that can lead to organizational cost saving. In this course, students will be trained on the fundamentals of Six Sigma, how to align it with business goals, the financial management of the project and the role of a Six Sigma manager.

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Lean Six Sigma Green Belt
This Lean Six Sigma Green Belt course helps develop the critical skills required to serve on project teams. Participants learn how to use many of the proven Six Sigma problem-solving methods and statistical tools to contribute to the success of their organization, including processes for collecting and analyzing data, and leading and executing process-level improvement projects. The training will be based on the industry standard “body of knowledge” for Lean Six Sigma. It will follow the proven roadmap known as Define, Measure, Analyze, Identify, and Control. You will be thoroughly trained on all green belt six sigma concepts, which will enable you as a green belt level specialist to immediately use your new skills by implementing six sigma into every area of your workplace. Whether you’re a large company, a small business, or an individual acquiring this knowledge base, you can quickly and easily acquire these new skills and use them immediately.

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Six Sigma Green Belt: Manufacturing
(The course is based on the ASQ Body of Knowledge for Certified Six Sigma Green Belt)
The Six Sigma Green Belt: Manufacturing course is intended for individuals with a manufacturing background and will focus solely on how Six Sigma applies to manufacturing. Students will learn how to appropriately apply Six Sigma tools, increasing efficiency in business processes. They will learn methodology and data collection techniques for eliminating process deficiencies, and statistical methods to quantify results of each process.

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Six Sigma Green Belt: Service
(The course is based on the ASQ Body of Knowledge for Certified Six Sigma Green Belt)
The Six Sigma Green Belt: Service course prepares individuals to implement Six Sigma processes that support improvement efforts in the service industry. Students will learn the responsibilities of Green Belt and how to appropriately apply Six Sigma tools. They will learn methodology and data collection techniques for eliminating process deficiencies, as well as statistical methods to quantify the results of each process.

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The Role of Creativity and Innovation in Leadership
Participants will discover the benefits to thinking-out-of-the-box as a leader. This course teaches participants how to bring creativity and innovation to their organization.

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Strategic Thinking and Decision Making
Participants learn the techniques of solving problems through strategic thinking and decision-making.

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CSU Dominguez Hills

Project Management Applications
In this course, an experienced Project Management Professional will teach you the same powerful tools and techniques that experienced project management professionals rely on every day. You'll increase the probability of project success by mastering the tricks of the trade: Earned Value Performance Measurement, Gantt Charts, Network Scheduling, Work Breakdown Structure, and Cost-Volume Analysis. You'll become proficient at recruiting project team members and empowering them to succeed. You'll understand the stages of team development, and you'll gain skills in developing and motivating team leaders. You'll learn how to understand and relate to an organizational culture and the differing characteristics of its work groups. ou'll also learn about project software, statistics, change management, processes, and estimating. And you'll gain valuable experience with project planning, control and data analysis tools. The course also includes essential information that will help you prepare for the Project Management Professional (PMP) and the Certified Associate in Project Management (CAPM) exams offered by the Project Management Institute (PMI). Certification Magazine recently identified PMP Certification as "the highest-paying certification" of the year.

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Project Management Fundamentals
In this six-week course, an experienced Project Management Professional will help you master the essentials of project management. You'll become an indispensable member of your project team by discovering and mastering the critical concepts you need to plan, implement, control and close any type of project. You'll learn about project politics and ethics, project measurements, and project closure. You'll be able to develop all sections of a project plan, you'll become comfortable with the project management body of knowledge, and you'll develop a variety of powerful techniques to generate project ideas. If you're new to project management, this course will provide you with the essential information you'll need to prepare for and complete your first project. If you're an experienced project manager, this course will make you more valuable to your employer by increasing your skills and competencies.

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High Speed Project Management
With accelerated schedules driving many technology projects today, the smart project manager must rapidly retool their skill set. This course offers a breakthrough model for dealing with the realities of managing projects at supersonic speeds. Learn to meet and win the challenges of truncated timelines, short-staffed project teams, skimpy budgets and crippling risks.

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Business Plan Development Workshops
A professional business plan is needed to evaluate a new venture proof of concept and attract funding. It is also recommended for small businesses that want additional debt or equity funding and/or to joint venture with larger companies. This program by Artilient Capital Partners™ offers all facets of business plan development, including assessing the market and competitive environment, developing your concept and growth strategies, creating marketing approaches, identifying a cohesive management team, designing operations, and developing financial projections.

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Entrepreneurship: Start-Up and Business Owner Management
Interested in starting, owning and operating a business? The Entrepreneurship: Start-Up and Business Owner Management program provides an excellent foundation for not just the start-up business owner, but also the business owner or manager who wants to gain a further basic and introductory understanding of some of the essential principles associated with owning and operating a start-up or on-going business. The program includes Business Plan Development, Positioning For and Finding Financing, Legal Issues in Operations, as well as Buying and Selling a Business. You will grow in your understanding of financial and accounting terms, gain confidence and improve your communication skills, as well as explore some of the topics of running a business in accord with legal requirements. It’s never been easier to get your own business up and running!

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Management Training
This nationally recognized Business Management Training Program and online course is perfect for a business owner, entrepreneur or anyone seeking to learn the introductory and foundational essentials in business and management. If you are thinking of starting a business or pursuing an MBA, learn the essentials here! The Management Training program consists of 12 separate modules geared to providing the vital information in a timely manner designed to fit your busy work and family schedules. This program will provide you with an introductory and basic understanding of financial and accounting terms, the successful negotiation strategies for most environments, and any necessary issues in the management of the marketing process, employment law, compliance and regulatory requirements, as well as licensing, permits and taxes, and successful negotiation strategies for most environments. This online certificate program is offered in partnership with major colleges, universities, and other accredited education providers and is best–suited for anyone with little or no management experience.

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CSU Fullerton

SBAE 5119 Project Management Overview
Management experts estimate that as much as 50 percent of work is done in the form of a project. However, many managers have had no formal experience or training in the field. Consequently, projects may have no clear starting or ending point. But even more importantly they may have no clear definition of what is to be accomplished, the time constraints or the budget. Overview of Project Management is designed to help you develop an understanding of the field of project management and terminology peculiar to the project management field. You will also begin to discuss project management processes.

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SBAE 5772 Managing Procurement, Planning and Risk in Projects
Developing a project plan, which may go through several iterations, should result in a coherent document that includes strategic planning and can be used to guide both the project execution and project control. Project planning must be systematic, flexible enough to handle unique activities, disciplined and capable of accepting multifunctional inputs. Planning must be performed throughout the life of the project and must completely define all work required. Project procurement involves identifying and managing the supply chain successfully while also administering the contracts. Managing risk factors occurs throughout the project with the objective of increasing positive events and minimizing the impact of negative events.

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SBAE 5122 Managing Quality and Communications in Projects
Project quality management includes all the planned and systematic activities required to ensure that the project will meet the objectives for which it was undertaken and includes quality planning, quality assurance and quality control. Communications management ensures timely and appropriate generation, collection, dissemination, storage and ultimate disposition of project information. It also provides the critical link among people, ideas and information. The impact that quality and communications management have on a project will be discussed.

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SBAE 5121 Project Management Skills in Time and Cost Management
Project time management involves sequencing of all project activities to support the development of a realistic and achievable schedule. Project cost management ensures that the project is completed within the approved budget and is primarily concerned with the cost of the resources needed to complete project activities.

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SBAE 5188 Project Execution and Control: Putting It All Together
Controlling activities in project management consists of measuring progress toward project objectives, evaluating what needs to be done and taking the necessary corrective action. Project managers are responsible for ensuring accomplishment of organizational goals and objectives. Project execution involves the implementation and carrying out (through others) of the approved project plans that are necessary to achieve or exceed objectives. Project execution and control will be topics of discussion in this class.

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SECS 5016 Six Sigma Black Belt, Advanced Statistical Techniques and Processes
Black Belts play a vital role within a Six Sigma initiative as they learn to supervise the Green Belts efforts of data collection and analysis and process mapping. This course will provide students with advanced tools and approaches to further enhance the process of using the DMAIC methodology. Student project presentation to the entire class will be re-evaluated using the additional techniques learned during this course.

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CSU Long Beach

Project Management Fundamentals
In this six-week course, an experienced Project Management Professional will help you master the essentials of project management. You'll become an indispensable member of your project team by discovering and mastering the critical concepts you need to plan, implement, control and close any type of project. You'll learn about project politics and ethics, project measurements, and project closure. You'll be able to develop all sections of a project plan, you'll become comfortable with the project management body of knowledge, and you'll develop a variety of powerful techniques to generate project ideas. If you're new to project management, this course will provide you with the essential information you'll need to prepare for and complete your first project. If you're an experienced project manager, this course will make you more valuable to your employer by increasing your skills and competencies.

For more information or to apply click here Opens in a new window..

Total Quality Fundamentals
Learn how to effectively apply the fundamentals of total quality. Understand what quality is and learn about the history of the quality movement. Discover the role of customers in quality and determine the major elements of a quality system. Master key concepts such as the cost of nonquality, variation, and total employee involvement (TEI). Increase your value to your company by learning about various motivational models, leadership, and teamwork. Determine how to effectively apply quality standards by creating and implementing internal and external auditing activities. Learn the ins and outs of ISO 9000, ISO 14000, and the Malcolm Baldrige National Quality Award. In this six-week online course, you will learn how successful organizations apply quality to their everyday activities. You will find out how to use teamwork to make the most of employees' abilities and potential. I will help you manage the process of change, reduce customer complaints, and increase customer service. You will learn of a number of quality fallacies and how to lessen their impact.

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Six Sigma: Total Quality Applications
Learn how to effectively apply the elements and methods of Six Sigma. This course will help you prepare for the internationally-recognized Six Sigma Black Belt and Quality Manager exams offered by the American Society for Quality® (ASQ®).

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Leadership
Leadership skills can help you gain the respect and admiration of others, while also allowing you to enjoy success in your career and more control over your destiny. Contrary to popular belief, leadership skills can be learned and developed. Even if you don't hold a leadership position, this course will teach you how to use the principles of great leaders to achieve success in almost every aspect of your daily life.

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Creating a Successful Business Plan
Turn your business ideas into a solid plan for financing and long-term success. Committing your idea to paper in the form of a business plan not only increases your chances of obtaining financing, but also in keeping your business strategically focused. With the support of your instructor and a network of like-minded students, you'll work through all of the major components of a business plan and emerge with your first draft in hand. And most importantly, you will have completed the first--and most difficult--step on the path to small business success.

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CSU San Marcos

Project Management Fundamentals
In this six-week course, an experienced Project Management Professional will help you master the essentials of project management. You'll become an indispensable member of your project team by discovering and mastering the critical concepts you need to plan, implement, control and close any type of project. You'll learn about project politics and ethics, project measurements, and project closure. You'll be able to develop all sections of a project plan, you'll become comfortable with the project management body of knowledge, and you'll develop a variety of powerful techniques to generate project ideas. If you're new to project management, this course will provide you with the essential information you'll need to prepare for and complete your first project. If you're an experienced project manager, this course will make you more valuable to your employer by increasing your skills and competencies.

For more information or to apply click here Opens in a new window.

Six Sigma Black Belt
The Black Belt training program integrates online learning with hands-on data analysis. The course material provides an in-depth look at the DMAIC problem-solving methodology, as well as deployment and project development approaches. The course flow follows the DMAIC methodology, with the appropriate tools and concepts taught at each stage of project deployment. Since software will be used for data analysis, the course material concentrates on the application and use of the tools, rather than on detailed derivation of the statistical methods. Workshops are incorporated extensively throughout the training to challenge the student’s analytical and problem-solving skills.

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Six Sigma Green Belt
Six Sigma Greenbelt is a Quality Improvement methodology structured to reduce product or service failure rates. This online program encompasses all aspects of a business, including management, service delivery, design, production and customer satisfaction. Six Sigma is one of the highest standards for companies and individuals to achieve. This interactive online experience provides the skills needed to affect this highly valuable skill as well as prep for the national certification. All materials are included. 

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Entrepreneurship: Start-up and Business Owner Management
This nationally recognized Entrepreneurship course and online training program teaches students the skills needed to start their own business. This Entrepreneurship: Start-Up and Business Owner Management program provides an excellent foundation for not just the start-up business owner, but also the business owner or manager who wants to gain a further understanding of some of the essential principles associated with owning and operating a start-up or on-going business. The program includes Business Plan Development, Positioning For and Finding Financing, Legal Issues in Operations, as well as Buying and Selling a Business. You will grow in your understanding of financial and accounting terms, gain confidence and improve your communication skills, as well as explore some of the topics of running a business in accord with legal requirements. It’s never been easier to get your own business up and running!

For more information or to apply click here Opens in a new window.


San Diego State University

PM 0007 Project Management Professional (PMP) Certification Prep Express
You have the experience – now it’s time to earn your credential as a PMI-certified project manager. Our PMP® Certification Prep Express course will help you prepare for the Project Management Institute (PMI®) PMP® certification exam. This industry-recognized credential is one of the fastest growing certifications in today’s job market.

For more information contact: Tamara McLeod at tmcleod@mail.sdsu.edu or call (619) 594-5640 or visit the course website Opens in a new window.

PM0 006 Project Management Fundamentals
This two-day course provides a solid understanding of the project management life cycle and practical experience with the tools and techniques of project management. You’ll learn how to initiate, plan, monitor, control, and This two-day course provides a solid understanding of the project management life cycle and practical experience with the tools and techniques of project management. You’ll learn how to initiate, plan, monitor, control, and closeout your projects more effectively. This training provides practical skills, concepts, and principles you can take back to the job and implement right away.

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OL 0075 Advanced Project Management
Courses in this program include:

* Building Productive Stakeholder Relationships
* Project Estimating Techniques
* Managing Accelerated Projects
* Setting Up a Project Office
* Portfolio Management
* Project Management Maturity

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RA 601 Pharmaceutical, Biotechnology, and Medical Device Industries
(Offered only as a distance education course) Pharmaceutical, biotechnology, and medical device industries. Company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control and marketing.

For more information call (619) 594-6030 or click here Opens in a new window.

RA 602 Food and Drug Law
(Offered only as a distance education course) Laws governing drug, biological, and medical device products. Discussion of Federal Food, Drug, and Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.

For more information call (619) 594-6030 or click here Opens in a new window.

RA 696 Advanced Topics in Regulatory Affairs: Quality Improvement Management
Quality improvement procedures to control and facilitate change in biotechnology industry. Traditional quality tools and process improvement methods are applied to the biotechnology industry to create strong relationships with management and peers, communicating financial returns from a quality initiative, and selling benefits in a consultative manner.     

For more information call (619) 594-6030 or click here Opens in a new window.

RA 770 Current Good Manufacturing Practice
Current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records. (Offered only as a distance education course)

For more information call (619) 594-6030 or click here Opens in a new window.

OL 0045 Overview ISO 9000:2000
Courses in this program include:

* The Who, What, & Why of ISO 9000:2000
* Building a Quality Management System
* Quality-minded Management
* Customer Satisfaction through Resource Management
* Processes Leading to Successful Products & Services
* Continual Quality Improvement
* Steps for Successful ISO Registration

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OL 0060 Supply Chain Management
Courses in this program include:

* The Fundamentals of Supply Chain Management
* Supply Chain Management Strategies
* Supply Chain Planning and Inventory Management
* Supply Chain Management and e-Business
* Supply Chain Transportation and Facility Design

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Leading Strategically: Critical Skills for Effective Leadership During Challenging Times
A dynamic leadership program examining opportunities for enhancing business success by refining the leadership skills of advanced managers. This program is a must for anyone eager to prepare themselves for further leadership opportunities.

For more information contact: Tamara McLeod at (619) 594-5640 or tmcleod@mail.sdsu.edu or click here Opens in a new window.


San Francisco State University

Quality Compliance GXP
This is a survey of quality standards that biotechnology, pharmaceutical, and device companies must adhere to when conducting clinical trials. Quality standards include Good Manufacturing Practice (GMP) or Quality Systems Regulation (QSR), Good Laboratory Practice (GLP), ISO 9000, and medical device regulatory standards.

For more information contact: Program Director at (415) 817-4226 or click here Opens in a new window.

Compliance Audits & FDA Inspections
Regulatory authorities may conduct routine or for-cause inspections of sponsor and study sites during clinical trials and routine inspections prior to product approval. This is an overview of FDA and sponsor audit procedures, roles, processes, and responses to findings.

For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or click here Opens in a new window.

Regulatory Processes & Issues
The FDA and other regulatory agencies establish rules and guidances for clinical development and marketing of drugs, biologics, and devices. This course provides an overview of drug development and the regulatory process that is necessary to get drugs approved. The course will provide students with a good basic understanding of the regulations involved in drug development, how the technical areas (i.e., manufacturing, pre-clinical and clinical) interact during that development, and where to find information to guide that development. This class will include lectures, hands-on workshops and class presentations.

For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or click here Opens in a new window.

Medical Devices
Regulation plays a key role in the design, development and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation.

This course provides an overview of the medical device industry, US and International regulations and the development of medical devices. In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines its regulatory pathway.

Through lectures and case studies, students will be introduced to the medical device development and approval process and learn about different strategic choices for marketing medical devices. Non-clinical and clinical testing of devices is reviewed, including the investigational device exemption (IDE) application process and the FDA quality systems regulations (QSR) for manufacturers. Marketing applications such as 510(k) exempt devices, special, abbreviated, and traditional pre-market notifications [510(k)s] and pre-market approval applications (PMAs) will be discussed. In vitro diagnostic devices (IVDs) and combination products are also briefly reviewed.

For more information contact: Program Director at (415) 817-4226 or cflight@sfsu.edu or click here Opens in a new window.