PDA 569 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases

This training course offers an in-depth explanation of effective risk management strategies specifically tailored for the unique challenges of drug device combination products. The course will begin by covering key standards and regulations such as ISO 14971, ICH Q9, AAMI TIR 105, and QMSR, diving into best practices for managing risks associated with drug delivery devices and combination products. Participants will engage with practical tools and techniques, including Hazard Analysis, Use Related Risk Analysis, Design/Process FMEAs, Fault Tree and Reliability Analysis, and Risk Matrix. Throughout this training course, participants will also learn how to effectively integrate Risk Management with Design Controls, Quality by Design (QbD) and explore the principles for Essential Performance Requirements (EPRs), Critical Quality Attributes (CQAs), and Control Strategies from engineering science perspective.

The training course will feature a session with an FDA senior pharmaceutical quality assessor, providing insights into quality assessment of injectable drug-device combination products with the focus on ANDA submission. This session will enrich participants’ understanding of the Quality by Design (QbD) approach to risk assessment, product development (suitability for the intended use), and control strategy, preparing them for market readiness.

Additionally, participants will explore the safety assurance case method, which is employed to convincingly argue that a product is safe for its intended use. Discussions will focus on how constructing assurance cases can enhance the completeness, correctness, and adequacy of risk management processes and outcomes. By the end of this training course, participants will be equipped with the knowledge and tools necessary to improve their organization's risk management practices.

Upon completion of this training course, the attendee will be able to:

1. Recognize unique 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 Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Use 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

For more options and/or related training courses, please visit the following page(s):

• PDA Parenteral Packaging Training Courses
• PDA Universe of Pre-Filled Syringes and Injection Devices Training Courses