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

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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.

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PDA Parenteral Packaging Training Courses

  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

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Standard Pricing

Standard Member Price

$899

GovernmentMember Only

$899

Health AuthorityMember Only

$899

Early Career ProfessionalMember Only

$899

StudentMember Only

$899

AcademicMember Only

$899

Non-Member

$899

See Qualifying Criteria for Member Types.

Day 1

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)

Day 2

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)

Day 3

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)

Agenda is subject to change.

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