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

Nov 02 - Nov 04, 2021
1:30 PM
4:30 PM
| Eastern Standard Time
  • Virtual
  • Education
  • Online


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.

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

PDA Parenteral Packaging Training Courses


  • Day 1
  • Day 2
  • Day 3
  • Welcome and Introductions (20 min)

    Risk Management Fundamentals Overview (30 min)

    What is New in ISO 14971:2019, ISO 24971:2020 and of AAMI TIR 105 (30 min)

    Break (10 min)

    Risk Management Challenges for Drug Delivery Device and Combination Products and Introduction (30 min)

    Risk Analysis Tools – System Boundary Diagram, Preliminary/System Hazard Analysis for Drug Delivery Combination Products (60 min)

  • Recap Day 1 and Homework Review (20 min)

    Risk Analysis Tools – Use Error Risk Analysis, HACCP, Function/Design FMEA, Process FMEA (60 min)

    Break (10 min)

    Top Down and Bottom-Up Consolidation Analysis and Risk Assessment Summary (30 min)

    System Hazard Fault Tree Analysis and Reliability Analysis (60 min)

  • Recap Day 2 and Homework Review (15 min)

    Introduction of Safety Assurance Cases (40 min)

    Application of Safety Assurance Case for Drug Delivery Device and Combination Products (25 min)

    Break (10 min)

    Develop a Safety Assurance Case for Drug Delivery Device and Combination Products (60 min)

    FDA’s Review of Safety Assurance Case for Premarket Submissions (30 min)


Fubin Wu
Fubin Wu

Learning Objectives

  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

Who Should Attend

This training course is intended for professionals who are involved in risk management and safety assurance cases related to drug delivery devices and combination products.

  • Quality Control
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Validation

  • Analyst
  • Specialist
  • Supervisor
  • Manager
  • Auditor/Inspector

Registration Fees

Register Now
Registration Type Price
All Participants $899

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