Pharma / BiotechMedical Device
The market’s Tolerance for Failure of Drugs, Devices and IVDs has reduced significantly since the 80s. This reduced tolerance is a reflection of a general loss of confidence in the medical industry. Adoption and certification of Quality Management Systems (QMS) has provided some recovery of that lost confidence but not enough – more is needed
New requirements combined with concepts and applications of Risk Management as a practical set of principles, have emerged and when integrated with Quality Management Systems re-build confidence for the three major stakeholder groups: Regulators, Industry and most importantly the Medical Community - including users & patients.
This course will cover Risk Management principals associated standards and practices together with how to develop, apply and implement strategies that reduce risks in the areas of drugs, devices and IVDs while working within established Quality Management Systems.
Topics covered include:
The course will identify the close link between Risk Management and QMS elements such as: Design Controls, Corrective and Preventive Action, Supplier Management, Change Control, Complaint Handling, and Production and Process Control
This two-day course is designed for quality managers, engineers, auditors, regulatory/quality compliance professionals, clinical & product specialists, R&D engineers, laboratory professionals, product development professionals, production managers and top management interested in learning the value of risk management principals and integration with Quality Management Systems to better utilize resources and data to optimize the risk management processes.
The overall goal of this training is to establish awareness and practical understanding of the advantages of integrating QMS & Risk Management to enhance sustainability of both product and business by improving patient safety, clinical outcomes and business predictability.
This training will provide a broad introduction to the subject of risk management for both new and more experienced personnel, including middle and upper management. Participants will broaden and update their knowledge of US and international risk management requirement
Introduction to Risk Management
Risk Management Process
Comparison of Risk Management Requirements
Implementing Risk Management in Your Organization
The importance of the right culture and people
The Process Frame
Starting the Risk Management Process
Expanding the Application of Risk Management: The Application of Risk Management to the Quality Management System
The Application of Risk Management to the Quality Management System
Recognizing and Understanding the Tools of Risk Management
Working Session I:
Working Session II:
Challenges with Implementing Risk Management
General Discussion and Questions
Upon completion of this course, attendees will understand how to effectively meet and integrate the requirements of Quality Management and Risk Management in the health product areas of Medical Devices, Pharmaceutical/Biopharmaceuticals and IVDs.
Course Objectives Include:
"The course was a very good introduction to the concept of integrating Risk Management into the existing Quality management System. It was well presented and well explained." Ladi O., Device Safety Leader, Bayer
"Great course, great spokesperson! Highly recommend! I for one especially appreciated the following, Real-life examples from all walks of business, Providing the standard, laws and guidance from a global perspective was very refreshing and enlightening and the Workshop was great as well." Goldi, Director, Pharm. Tech., Otsuka
"The material was thorough and comprehensive. The Course Director is clearly an expert on risk management and the right person to teach the course. He is articulate, patient, and can cater the material to an audience in many different groups and industries. In addition, he has created several useful workshops that forced the class to apply the risk management principles he was teaching." Jonathan K., Quality Systems Specialist, Boehringer Ingelheim Chemicals
"All course materials were helpful, especially the worksheets. I will be able to bring them back to my company and start using them to improve our processes. Instructor gave good insight into the FDA perspective and what an investigator would be looking for in a risk management plan." Leah S. Proc. Development Engineer, Alkermes
"Excellent course, well delivered and useful notes I can refer to later. Good group exercises." Michael K., Department Manager, PM Group
"This class will enable me to network and gain a better understanding of risks. Great job!" Kim B., Manager of GMP Quality, Merck
"The Course Director was excellent in explaining material. When I came in, I didn't know much about the topic and when I left on the last day I felt like I could share ideas with others." Melissa R., Scientist, Business Operations, Glaxo (GSK)
"The exercises give 'practical application' to the information given in the lecture." Christy, S., Quality Assurance, W.L. Gore & Associates
"This course provided excellent tools that we will be able to implement immediately." Scott W., QA Manager Johnson & Johnson
"The complicated topics were made simple and understandable for new QA staff." Raymond N., Sr. Medical Advisor & Safety Officer, Baxter
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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