Pharmaceutical Quality Risk Management (QRM) and ICH Q9(R1) - Critical Elements Of Proactive Approach to Risk

Quality Risk Management (QRM) s crucial in ensuring the safety and effectiveness of pharmaceutical products. By implementing a systematic and proactive approach to managing risks, you can safeguard product quality, patient safety, and data integrity throughout the product lifecycle. Our webinar will provide you with an understanding of the principles, concepts, and application of risk management in the pharmaceutical industry, aligning with regulatory expectations and industry best practices. The revised version, ICH Q9(R1), plays a pivotal role in promoting a proactive and systematic approach to risk management. It outlines the requirements for applying risk management to the quality system, emphasizing its integration throughout the product lifecycle.

WHY YOU SHOULD ATTEND:

You will be guided through risk management principles, tools, methods, and processes specifically tailored for the pharmaceutical industry. We will also delve into communication techniques to highlight the benefits of risk management and showcase real-world examples of its applications. By the end of this session, you will be equipped with the knowledge and skills to develop and implement a holistic risk management strategy within your organization. This webinar is particularly valuable for professionals involved in the FDA approval process for quality risk management within the pharmaceutical industry. It will provide you with best practices, industry insights, and the necessary tools to enhance your understanding of QRM.

LEARNING OBJECTIVES:

• Understand ICH Q9(R1) significance: Learn about ICH's role and the importance of ICH Q9(R1) for quality risk management in pharma.
• Comprehend key concepts: Grasp risk definitions and terms like assessment, control, communication, and review.
• Learn risk management process: Understand ICH Q9(R1) steps: identify, evaluate, control, communicate, and review.
• Explore risk management integration: See how it applies in manufacturing, drug development, and post-marketing.
• Overview Quality Risk Management methods: Get a summary of best practices and tools.
• Identify potential applications: Discover how regulators use risk management principles and tools.

AREAS COVERED IN THE SESSION:

• Introduction to ICH (Q9) R1 Regulations 
  • A brief overview of ICH and its purpose 
  • Introduction to ICH Q9 and its Significance
• What is Risk Management?
  • Regulatory Requirements
  • Key Definitions
  • Exploring Risk Management (RM) Process – Systematic and Integrated
  • Reviewing RM Principles
• Risk Management Implementation
  • Using Risk Management Tools and Methods (PHA, HAZOP, HACCP, FTA, FMEA, FMECA)
  • How to Perform Risk Ranking
  • How to Facilitate Quality Risk Management
  • Common Mistakes and How to Prevent Common Pitfalls
  • Implementing Risk Control Measures
• Risk Management Application and Integration
  • Risk Communication – How
  • Application of ICH Q9 in pharmaceutical manufacturing 
  • RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Testing and Quality Control
  • Relationship with Other Quality Systems
  • Implementing RM in an Efficient and Effective Manner

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Manufacturing Departments
• Research and Development Departments
• Engineering Departments
• Regulatory Affairs Departments
• Operations Departments
• Chemists
• Scientists
• Formulators
• Documentation Specialists
• Auditors
• Technicians
• Compliance Officers
• Process Engineers
• Validation Specialists
• Product Development Managers
• Drug Safety Specialists
• Every Risk Management Professional

Course Director: DANIELLE DELUCY

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems  assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.