Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products
Ensure Safe, Compliant Pharmaceuticals With Proactive Risk Management Across the Product Lifecycle!
Instructor :
Meredith Crabtree
Webinar ID:
12563
Date: NOV 22, 2024 (FRI)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🔍 Quality & Safety Assurance Master Pack (Pack of 3)
“Strengthen Quality and Risk Management for Safe Pharmaceutical Products”
3 Courses Included:
-
- Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products, duration 90 Mins., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards, duration 60 Mins., find out more details here
- Quality Management 101: Optimizing Enterprise Maintenance with ISO Standards, duration 60 Mins., find out more details here
Why This Pack?
This bundle equips professionals with critical knowledge in quality assurance and risk management, from new drug applications to overarching quality management systems (QMS). It’s ideal for professionals dedicated to maintaining high standards in product safety and regulatory alignment.
Target Audience: Quality Assurance Managers, Regulatory Affairs Specialists, Pharmaceutical Production Managers
Why Buy the Pack?
-
- End-to-End Quality Management: Gain in-depth expertise from drug applications to quality systems management.
Buy This Course in a Pack of 3 courses at 35% Discount HERE:
🔍 Quality & Safety Assurance Master Pack (Pack of 3)
“Strengthen Quality and Risk Management for Safe Pharmaceutical Products”
3 Courses Included:
-
- Quality Risk Management: An In-Depth Guide to ICH Q9 (R1) for Safe and Effective Pharmaceutical Products, duration 90 Mins., find out more details here
- Fast-Track FDA Approvals: Mastering NDAs, INDs, and Drug Manufacturing Standards, duration 60 Mins., find out more details here
- Quality Management 101: Optimizing Enterprise Maintenance with ISO Standards, duration 60 Mins., find out more details here
Why This Pack?
This bundle equips professionals with critical knowledge in quality assurance and risk management, from new drug applications to overarching quality management systems (QMS). It’s ideal for professionals dedicated to maintaining high standards in product safety and regulatory alignment.
Target Audience: Quality Assurance Managers, Regulatory Affairs Specialists, Pharmaceutical Production Managers
Why Buy the Pack?
-
- End-to-End Quality Management: Gain in-depth expertise from drug applications to quality systems management.
- Safety First: Prioritize product safety and compliance with robust quality frameworks.
- Optimal Value: Comprehensive quality assurance guidance at a lower cost than individual purchases.
Note: Do you want to custom design your pack and choose courses of your choice? Just drop us an email at support@compliancemeet.com or call at Toll Free: +1 (888) 959-4972. We’ll be happy to help you!
                                 Buy All 3 Courses at a 35% discount HERE
What will you learn
-
- Introduction To ICH Q9 (R1) And Its Regulatory Importance
- Defining Key Risk Management Concepts And Quality Principles
- Detailed Steps In The Risk Management Process For Compliance
- Applying Risk Management Across Drug Development And Manufacturing
- Essential Quality Risk Management Tools And Industry Best Practices
- Practical Applications Of Quality Risk Management In ….
-
- Introduction To ICH Q9 (R1) And Its Regulatory Importance
- Defining Key Risk Management Concepts And Quality Principles
- Detailed Steps In The Risk Management Process For Compliance
- Applying Risk Management Across Drug Development And Manufacturing
- Essential Quality Risk Management Tools And Industry Best Practices
- Practical Applications Of Quality Risk Management In Pharmaceuticals
- Ensuring Patient Safety And Regulatory Compliance Through QRM
Course Description
In today’s pharmaceutical landscape, effective Quality Risk Management (QRM) is essential to ensure product quality, patient safety, and data integrity.
The revised ICH Q9 (R1) guideline provides a robust framework to manage these risks across the entire product lifecycle, from initial development to post-market monitoring.
This 90-minute training session is designed to help participants understand the core principles and concepts of ICH Q9 (R1) and its critical role in aligning with regulatory standards and industry best practices.
Participants will gain:
-
- A comprehensive understanding of Quality Risk Management in the pharmaceutical industry
- Insight into the proactive and systematic approach recommended by ICH Q9 (R1)
- Practical knowledge of QRM tools and techniques widely used across the industry
What You’ll Learn:
-
- How to integrate risk management into every stage of the product lifecycle
- Strategies to enhance product quality and ensure patient safety
- Real-world examples and applications of QRM principles for immediate use
By the end of this course, attendees will be equipped to apply the latest ICH Q9 (R1) guidelines to their work, ensuring compliance and safeguarding safe, effective pharmaceutical products for patients worldwide.
Enroll Now!
In today’s pharmaceutical landscape, effective Quality Risk Management (QRM) is essential to ensure product quality, patient safety, and data integrity.
The revised ICH Q9 (R1) guideline provides a robust framework to manage these risks across the entire product lifecycle, from initial development to post-market monitoring.
This 90-minute training session is designed to help participants understand the core principles and concepts of ICH Q9 (R1) and its critical role in aligning with regulatory standards and industry best practices.
Participants will gain:
-
- A comprehensive understanding of Quality Risk Management in the pharmaceutical industry
- Insight into the proactive and systematic approach recommended by ICH Q9 (R1)
- Practical knowledge of QRM tools and techniques widely used across the industry
What You’ll Learn:
-
- How to integrate risk management into every stage of the product lifecycle
- Strategies to enhance product quality and ensure patient safety
- Real-world examples and applications of QRM principles for immediate use
By the end of this course, attendees will be equipped to apply the latest ICH Q9 (R1) guidelines to their work, ensuring compliance and safeguarding safe, effective pharmaceutical products for patients worldwide.
Enroll Now!
Why you should attend
In an industry where patient safety, product quality, and regulatory compliance are paramount, understanding and implementing ICH Q9 (R1) Quality Risk Management is essential.
This training offers practical insights and tools to enhance your risk management skills, drive compliance, and advance your career in the pharmaceutical sector.
By attending this session, you will gain critical expertise that enables you to:
-
- Strengthen Compliance and Risk Management: Ensure that your organization meets regulatory expectations and industry standards, mitigating risks to patient safety and product quality.
- Enhance Decision-Making: Use structured risk management techniques to make informed, data-driven decisions that positively impact your projects and organization.
- Promote a Culture of Continuous Improvement: Equip yourself with tools that encourage proactive risk management across all stages of product development and lifecycle.
- Improve Cross-Functional Collaboration: Gain a framework to work seamlessly with different departments to manage risks collectively and improve overall quality systems.
Through this training, you will:
-
- Understand the Purpose and Significance of ICH Q9 (R1): Learn about the International Council for Harmonisation (ICH) and the role of ICH Q9 (R1) as a standard for quality risk management in the pharmaceutical industry.
- Comprehend Key Concepts and Definitions: Master foundational concepts such as risk assessment, risk control, risk communication, and risk review to confidently apply them in your role.
- Master the Risk Management Process: Discover the five key steps in ICH Q9 (R1)’s risk management process—from risk identification to risk review—and learn how to implement each step effectively.
- Recognize Integration Across the Pharmaceutical Lifecycle: Gain insights into applying risk management principles in areas like drug development, manufacturing, and post-marketing activities.
- Explore Quality Risk Management Methods and Tools: Familiarize yourself with proven QRM methods and tools used throughout the industry for maintaining high-quality standards.
- Identify Practical Applications for Quality Risk Management: Learn how to leverage QRM tools in your daily work and understand their use in regulatory contexts.
Equip yourself with the expertise to contribute directly to safe, effective pharmaceutical products and be a part of a safer, more compliant industry.
Join us for this essential training and stay ahead in the field of Quality Risk Management.
Register Today!
In an industry where patient safety, product quality, and regulatory compliance are paramount, understanding and implementing ICH Q9 (R1) Quality Risk Management is essential.
This training offers practical insights and tools to enhance your risk management skills, drive compliance, and advance your career in the pharmaceutical sector.
By attending this session, you will gain critical expertise that enables you to:
-
- Strengthen Compliance and Risk Management: Ensure that your organization meets regulatory expectations and industry standards, mitigating risks to patient safety and product quality.
- Enhance Decision-Making: Use structured risk management techniques to make informed, data-driven decisions that positively impact your projects and organization.
- Promote a Culture of Continuous Improvement: Equip yourself with tools that encourage proactive risk management across all stages of product development and lifecycle.
- Improve Cross-Functional Collaboration: Gain a framework to work seamlessly with different departments to manage risks collectively and improve overall quality systems.
Through this training, you will:
-
- Understand the Purpose and Significance of ICH Q9 (R1): Learn about the International Council for Harmonisation (ICH) and the role of ICH Q9 (R1) as a standard for quality risk management in the pharmaceutical industry.
- Comprehend Key Concepts and Definitions: Master foundational concepts such as risk assessment, risk control, risk communication, and risk review to confidently apply them in your role.
- Master the Risk Management Process: Discover the five key steps in ICH Q9 (R1)’s risk management process—from risk identification to risk review—and learn how to implement each step effectively.
- Recognize Integration Across the Pharmaceutical Lifecycle: Gain insights into applying risk management principles in areas like drug development, manufacturing, and post-marketing activities.
- Explore Quality Risk Management Methods and Tools: Familiarize yourself with proven QRM methods and tools used throughout the industry for maintaining high-quality standards.
- Identify Practical Applications for Quality Risk Management: Learn how to leverage QRM tools in your daily work and understand their use in regulatory contexts.
Equip yourself with the expertise to contribute directly to safe, effective pharmaceutical products and be a part of a safer, more compliant industry.
Join us for this essential training and stay ahead in the field of Quality Risk Management.
Register Today!
Areas Covered
- Introduction to ICH Q9 (R1) Regulations
- Overview of the International Council for Harmonisation (ICH) and its purpose
- Introduction to ICH Q9 and its significance in Quality Risk Management
- Key Concepts and Definitions
- Defining Risk and Risk Management in a pharmaceutical context
- Exploring the Principles of Quality Risk Management (QRM)
- Detailed look at Risk Assessment, Control, Communication, and Review
- The Risk Management Process
- Step-by-step overview of the Risk Management Process outlined in ICH Q9 (R1)
- Risk Identification: Recognizing potential risks affecting quality and safety
- Risk Evaluation: Assessing the impact and likelihood of identified risks
- Risk Control: Strategies to mitigate or eliminate risks
- Risk Communication: Ensuring risk-related information is shared effectively
- Risk Review: Regularly reviewing risk controls for continuous improvement
- Step-by-step overview of the Risk Management Process outlined in ICH Q9 (R1)
- Integration of Risk Management in the Pharmaceutical Industry
- Applying ICH Q9 guidelines in Pharmaceutical Manufacturing
- Implementing risk management principles in Drug Development
- Managing risks in Post-Marketing Activities to maintain product safety
- Quality Risk Management Methods and Tools
- Overview of essential QRM Tools and techniques used in the industry
- Best practices for implementing these methods to enhance product quality
- Potential Applications for Quality Risk Management
- Identifying practical applications for QRM principles within regulatory and industry frameworks
- Real-world examples illustrating the role of QRM in maintaining patient safety and regulatory compliance
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
- Introduction to ICH Q9 (R1) Regulations
- Overview of the International Council for Harmonisation (ICH) and its purpose
- Introduction to ICH Q9 and its significance in Quality Risk Management
- Key Concepts and Definitions
- Defining Risk and Risk Management in a pharmaceutical context
- Exploring the Principles of Quality Risk Management (QRM)
- Detailed look at Risk Assessment, Control, Communication, and Review
- The Risk Management Process
- Step-by-step overview of the Risk Management Process outlined in ICH Q9 (R1)
- Risk Identification: Recognizing potential risks affecting quality and safety
- Risk Evaluation: Assessing the impact and likelihood of identified risks
- Risk Control: Strategies to mitigate or eliminate risks
- Risk Communication: Ensuring risk-related information is shared effectively
- Risk Review: Regularly reviewing risk controls for continuous improvement
- Step-by-step overview of the Risk Management Process outlined in ICH Q9 (R1)
- Integration of Risk Management in the Pharmaceutical Industry
- Applying ICH Q9 guidelines in Pharmaceutical Manufacturing
- Implementing risk management principles in Drug Development
- Managing risks in Post-Marketing Activities to maintain product safety
- Quality Risk Management Methods and Tools
- Overview of essential QRM Tools and techniques used in the industry
- Best practices for implementing these methods to enhance product quality
- Potential Applications for Quality Risk Management
- Identifying practical applications for QRM principles within regulatory and industry frameworks
- Real-world examples illustrating the role of QRM in maintaining patient safety and regulatory compliance
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance Leaders Focused on Compliance
- Pharmaceutical Department Heads Ensuring Product Safety
- Regulatory Affairs Managers Committed to Industry Best Practices
- Manufacturing Supervisors Mitigating Risks in Production Processes
- R&D Professionals Navigating Risks in Drug Development
- Training Managers Looking to Build a QRM Knowledge Base
- Compliance Officers Focused on Harmonizing Global Standards
- Supply Chain Managers Focused on Consistent Quality Across Suppliers
- HR and Learning Development Professionals Enhancing Risk Management Skills
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance Leaders Focused on Compliance
- Pharmaceutical Department Heads Ensuring Product Safety
- Regulatory Affairs Managers Committed to Industry Best Practices
- Manufacturing Supervisors Mitigating Risks in Production Processes
- R&D Professionals Navigating Risks in Drug Development
- Training Managers Looking to Build a QRM Knowledge Base
- Compliance Officers Focused on Harmonizing Global Standards
- Supply Chain Managers Focused on Consistent Quality Across Suppliers
- HR and Learning Development Professionals Enhancing Risk Management Skills
Instructor Profile
Meredith L. Crabtree has over 30 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical Device, Cosmetics, Supplements, and Animal Health. This includes manufacturing, packaging, labelling and distribution operations.
Meredith is the owner of MLKC Consulting is a Quality Consultant specializing in product label reviews, 3rd party inspections, Consent Decree and Recall support. She also performs regulatory assessments and Quality trainings
