Professional Biotechnology Project Management Certificate in Quality Assurance

Overview

This new online, graduate-level certificate blends project management and quality assurance because that has become a requirement for most modern quality initiatives. Creating and controlling structured change within the medical environment requires focused efforts with high level support, goals, planning, teamwork, and highly trained experts to guide the effort, all within the framework of a project. This certificate has been co-developed with biotechnology professionals from the American Society of Quality (ASQ) and project managers working in the biotechnology industry. The quality assurance certificate focuses on the skills and tools required to successfully manage product development and quality assurance projects in the life sciences industry, including medical device, pharmaceutical, and biopharmaceutical companies. Participants will learn the importance of leadership and effective communications in managing and implementing process changes and improvements, while complying with regulatory requirements.

This certificate is offered jointly by Extended University at CSU Channel Islands, CSU Dominguez Hills and San Diego State University.

Program Benefits

Learn the theory and practical techniques to successfully manage product development and quality assurance projects
Improve leadership, communication and other key managerial skills
Develop a good understanding of life sciences industry's regulatory environment and ethical issues
Learn industry best practices in project management and quality assurance, including current Good Manufacturing Practices (cGMP)
Gain practical knowledge and tools for your career development
Be able to balance certificate with ongoing professional commitments through flexible, online courses
Learn from instructors with relevant experience in the life sciences industry
Transfer credits to accredited graduate programs: CSU Channel Islands Masters in Biotechnology program and CSU Dominguez Hills Master of Science in Quality Assurance program

Who Should Enroll

Quality assurance, manufacturing and regulatory affairs professionals and life sciences industry researchers and product developers.

Eligibility Requirements

Students should hold a bachelors degree to qualify for the professional certificate. A science or engineering background is also strongly suggested.

Course Schedule

Course Description	Schedule/Fees
CSU Channel Islands, MGT 471 Project Management (3 units) This course presents the principles of project management, which is a special form of work organization that focuses on a one-time objective. The course discusses all aspects of project management: definition of objectives, selection of team and other resources, establishing of timing and sequences, creation of monitoring and control processes, and development of analysis and reporting mechanisms. This course is intended to provide an overview of project management and its role in drug development. Specific areas of focus include the following: Project management principles and issues Core competencies and tools frequently applied Project management in the biotechnology industry	Jul. 26-Sep. 17, 2010 $2,385
CSU Dominguez Hills, QAS 511 Quality Function Management and TQM (3 units) This course provides a study of basic quality concepts as applied to organizational entities, with specific emphasis on the unique requirements of the biotech industry. TQM concepts, quality function deployment, and the tools for continuous improvement are analyzed for application and deployment in both biotech laboratory development and biotech manufacturing. Theories and methodologies examined in this course will assist these types of companies in achieving organizational excellence through continuous improvement.	Course Offered: Jan.19-Mar.12, 2010 Course Closed $1,350
San Diego State University, RA 696 Regulatory Affairs & Ethics (3 units) This course will provide foundational knowledge of the biotechnology, pharmaceutical and medical device industries, along with a comprehensive introduction to related regulatory affairs activities. The course will focus on the concept-to-market process for new drugs, biologics, and devices, along with the associated regulatory affairs roles of the company and the various regulatory agencies. An overview of related laws and regulations enforced by the US Food and Drug Administration (FDA) will be provided, with topics including the Food, Drug and Cosmetic Act; regulations affecting combination products, and diagnostics; and FDA enforcement. Current legal and ethical issues within these industries will be discussed, along with future trends.	Course Offered: Mar.22-May 14, 2010 Course Closed $1,566
CSU Dominguez Hills, QAS 539 Good Manufacturing Practices (3 units) This course examines FDA Good Manufacturing Practice regulations as applied to medical device, pharmaceutical production, and laboratory development. Device design covers development, manufacturing, quality records, management and organizational requirements as related to quality assurance methodologies. Pharmaceutical production and laboratory development include personnel, facilities and equipment, process and product controls, laboratory, reporting using the fundamentals of quality assurance methodologies as related to the biotech industry.	Course Offered: May 24-July 16, 2010 Course Closed $1,350

Note: Reasonable accommodations for persons with disabilities will be made, if requested at least two weeks in advance.

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to register. For general inquiries and more information on enrolling in the certificate program for your company contact: (619) 594-3954 or rbhathal@mail.sdsu.edu.

"The Biotechnology Project Management Certificate in Quality Assurance provides an accelerated, focused concentration in the necessary tools needed of project managers to successfully manage product development and quality assurance projects. The program establishes the missing connection between traditional science education and practical skills needed in the biotechnology industries."

Imre A. Fischer,
Ph.D., PE, FACB, ASQ Fellow
Chair, Awards & Recognition
Committee and Past Chair,
Los Angeles Section of ASQ

"The QA certificate fills a definite need in California for a quality education program in the specific area of Quality Management. This program will provide the various segments of the life sciences industry with trained and motivated personnel to fill key openings in both quality and regulatory departments of pharmaceutical and medical device companies. The program has been developed with inputs from industry practitioners, qualified educators and professional faculty to meet both educational and business needs."

Marty Wartenberg
Chief Inventor, ZeroBoundary