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Live eLearning - PDA 569.1 Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases

Nov 04 - Nov 05, 2020
1:30 PM
4:30 PM
| Eastern Standard Time
  • Virtual
  • Education
  • Online


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 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.

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

PDA Parenteral Packaging Training Courses


Edwin Bills
Edwin Bills
Edwin Bills Consultant
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: 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

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
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Research and Development
  • Regulatory Affairs
  • Validation

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

Registration Fees

Register Now
Registration Type Price
Member $600
Non-member $600
Gov't/Health Auth./Academic $600

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