Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases - Taiwan

Effective risk management is a new challenge for many drug/biologic companies as they become drug/biologic and combination product manufacturers from traditional drug/biologic manufacturers. In addition, constructing safety assurance cases helps to ensure the completeness and correctness of risk management results and the adequacy of the risk management process. When being proactively developed, safety assurance cases become an effective method to improve risk management effectiveness.

This new training course will help you explain in depth effective risk management principles, drug delivery combination product best practices and tools, including Hazard Analysis, Fault Tree and Reliability Analysis, Design/Process FMEAs, Use Error Risk Analysis, and Safety Assurance Cases, from effectiveness and regulatory compliance perspective.

1. Recognize challenges and opportunities for effective risk management of drug delivery combination products
2. Apply knowledge on how to use risk analysis tools such as: Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Error Risk Analysis
3. Identify risk controls effectively and efficiently for drug delivery of combination products
4. Indicate the appropriate elements of safety assurance cases that may be useful to demonstrate safety and facilitate communications with regulatory reviewers during premarket reviews
5. Identify industry best practices in managing risk and assuring safety through product life cycle