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Risk Management

for Medical Products

Genre: Diagnostics / Therapeutics
Length: 26 minutes
Keywords: Regulatory Affairs, FMEA, Medical Products, Approval, Drug Safety

Risk Management for Medical Products

Selling biomedical products on international markets must be accompanied by proper risk management. Risks affiliated to individual biotech product must be identified and minimised. Remaining risk must be in responsible dimensions to account for liability of manufacturing company.

Prospective project managers dealing with risk management must be in charge of tools to perform appropriate risk management. Here it is important to identify potential risks of biotech product and to be in compliance to international guidelines for risk control.

This seminar deals with current methods in risk management and strategies for optimal application of templates for individual risk assessment. Here implementation of suitable in-process controls lead to improved discoverability of potential mistakes.

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