Pharma / BiotechMedical Device
The regulatory and business requirements for the pharma, diagnostics, and medical-device fields continue to update, blend, overlap, and blur. With these changes, the importance of risk assessment—and risk management—gains higher business and regulatory significance. It now becomes even more important for professionals in these fields to recognize, accept, understand, and respond to these changes —particularly since new regulatory requirements have emerged within this changing environment.
The market’s Tolerance for Failure of Drugs, Devices, and IVDs has reduced significantly in recent decades. This reduction reflects a general loss of confidence in the medical industry. The adoption of formal Quality Management Systems (QMS) has recovered some of that confidence, but we must still do more. This course addresses what we can do.
When integrated with QMS—the collection of policies, procedures, processes, and resources designed to meet customer and regulatory requirements—risk management approaches and requirements can help further build confidence for the major stakeholders; including regulators, industry, and–most importantly–users and patients in the medical community.
Items covered include risk-management and QMS principles—as well as associated standards, and practices. The course addresses how to develop, apply, and implement risk management strategies within a QMS—helping reduce risk associated with drugs, devices, IVDs, and even business practices themselves.
This course examines similarities between the role of ICH in pharma and that of IMDRF in medical devices—including how regulations apply to emerging combination devices. It also identifies links between Risk Management and QMS, including Design Controls, Preventive/Corrective Action, Supplier Management, Change Control, Complaint Handling, and Production/Process Control.
This two-day course is designed for quality/production managers, engineers, auditors, regulatory/quality professionals, clinical/product specialists, R&D engineers, laboratory professionals, product-development professionals, and management. Those responsible for Quality System compliance and certification to ISO 13485 are urged to attend. Attendees will learn the value of risk-management principles, integration with QMS, and how to better utilize resources.
This program provides a broad introduction to risk management for both new and experienced personnel, including management. It establishes awareness and understanding of the advantages of integrating QMS and Risk Management. Attendees will learn how to enhance the sustainability of product and business by improving patient safety, clinical outcomes, and business predictability. In workshop exercises applying those principals, participants will broaden and update their knowledge of both U.S. and international risk-management requirements.
Introduction to Terms and Definitions
Regulatory Perspectives and Requirements
Key Factors of Risk Management
The Risk Management Process
Focus on tools and their application
Workshop Session I
Participants are divided into two groups and are presented with a combo-product description. An Initial Risk Assessment (IRA) is performed by each group: one assesses the pharma component; the other assesses the device component. Each group presents their results then the combined assessment is discussed.
Deeper Dive into Product Life Cycle and Risk Management
Real World Risk Management Integration into the QMS
Implementing Risk Management Integration
Workshop Session II
Part 1: Participants will select a QMS element and complete an initial Risk Assessment. Results will be shared and discussed by the group.
Introduction to a Wider Application of Risk Management Principals
Part 2: Using a selected QMS element participants identify an associated Business Objective and complete an initial Risk Assessment using ISO 31000 concepts. Results are shared and discussed by the group.
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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