PDA 569.2 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases

Effective and compliant risk management is a challenge for many drug/biologic companies as they become drug/biologic and device 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. When being proactively developed, safety assurance cases become an effective method to improve risk management effectiveness.

This live eLearning training course will help you explain in depth effective risk management principles, drug delivery combination product best practices, including tools such as Boundary Diagram for a Systems of Systems, Hazard Analysis, Use Error Risk Analysis, Fault Tree and Reliability Analysis, Design/Process FMEAs, 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: System Boundary Diagram, Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Error Risk Analysis
3. Identify risk controls and assess risks 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. Apply knowledge on how to develop a safety assurance case for a drug device combination product
6. Identify industry best practices in managing risk and assuring safety through product life cycle