Training Course:Risk Management Applications in the Product Development LifecycleSchool/Trainer:California State University Fullerton Fullerton, Garden Grove, Irvine, California, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' The FDAs risk-based approach to cGMP represents a significant paradigm shift for the pharmaceutical industry, impacting the product development lifecycle. This class will examine the various elements of risk management in the product development lifecycle in identifying critical risk milestones. You will gain an understanding of the appropriateness in applying new risk management tools at key points in the development lifecycle relative to regulatory guidelines ICH Q9, ISO 14971, and FDAs cGMP. Identifying high performance risk management teams, maintaining quality in the product development lifecycle, and regulatory compliance will also be addressed. ...''
Elements of this syllabus are subject to change.
Please go to the school's official website for training price and schedule:
http://www.csufextension.org/
Phone:714.278.2611
School Address:
California State University Fullerton College Park, Suite 100 2600 Nutwood Ave. (corner of Nutwood and Commonwealth) Fullerton, CA 92834-6870 USA
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Other training courses offered by California State University Fullerton:
Event Production and Meeting Space Layout
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Financial Management and Reporting
Grant Proposal Preparation
Pharmaceutical Risk Management
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Process Engineering in the Pharmaceutical Industry
Biotechnology and Bio-Processes
Facilities Design and Maintenance
Validation and Verification
Regulatory Affairs and Quality Assurance in the Pharmaceutical Industry
Navigating the Public Sector
Leadership in Public Administration
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