Provide a working knowledge and skills of the concepts and tools used in managing risk with applications to pharma and biopharma activities.
What is risk? How does an organization identify and reduce it?
Regulatory agencies world-wide are encouraging our industry to identify, assess, and manage the potential quality risks associated with pharmaceutical and biotech products. Pharmaceutical firms are also realizing that risk management is an important way to rationally set priorities for quality and compliance activities.
This two-day workshop presents the concepts of risk assessment and risk management to executives, managers, and technical personnel. Using examples and activities, participants learn about seven of the most frequently used tools and processes for identifying and rating risk. Integrated approaches to prevent risks from being expressed and protecting things of value are also presented.
Tools discussed include:
Those in management, quality, development, compliance, laboratory, operations, and other technical areas. Also, those who will participate in QRM teams and prospective QRM facilitators.
NOTE: As this course is being revised from the two day, face to face version to the half-day virtual format, topic items listed below may be re-arranged.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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