Understanding, Experience, and Technology for Compliance

Overview of the Key Components of a Risk Management Program for FDA Industry Manufacturers

Risk management concepts, principles, tools and techniques are effectively utilized in many areas of the FDA-regulated life sciences industries from pre-marketing, manufacturing and to post-marketing of regulated products. Although there are some examples of the use of quality risk management in the FDA industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceuticals industry and certainly with medical device manufacturers for all stages of device design through commercialization, and it is becoming evident that quality risk management is a valuable component of an effective quality system. Risk analysis is the systematic use of available information to identify hazards and the sequences of events that lead to hazardous situations. Risk estimation determines the level of risk from probability that harm will occur and the severity of that harm.

As risk cannot be completely eliminated, the risk that remains must be managed. This session will provide a comprehensive overview of the key concepts and principles associated with risk management and identify the use of best practices being used by manufacturers to facilitate this.
  • Review and discussion of  various methodologies for implementing and maintaining the RM programs 
  • Examples and applications of RM tools, including FMEA, FTA, etc.
  • Regulatory guidance, including ICH Q9 and ISO 14971 and informational sources to assist manufacturers
  • Best of breed practices to implement a Risk Management Program for FDA Industry Manufacturers 
  • Key Components influencing such a Risk Management Program

David Dills
David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities. David is global industry speaker and author of technical and compliance related topics published in industry journals.

Raghuraj Gaikwad
Manager, FDA Solutions, MetricStream

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