Quality Risk Management Training Course

Course overview

How does Quality Risk Management work?

Understanding and controlling the risks connected to any business or service provider establishment is the process known as quality risk management. There are always hazards involved with any company or sector in the country. Thus, it is impossible to undervalue the importance of having the information and comprehension necessary to regulate or mitigate such risks within an establishment. Quality risk management, then, is the methodical process of identifying, minimizing, sharing, and analyzing the risk related to pharmaceutical products.

The goal of this Training Bee course is to give the participant a thorough understanding of the industry standards for high-quality risk management in the healthcare industry. We will provide you the tools you need to make quick judgments in your line of work as a medical expert. Your ability to comprehend risk management standards effectively is the aim of the high-quality risk management training.

Lastly, we will go over the widely utilized Critical Control Point, Hazard Analysis, and Failure Mode Effect Analysis (FMEA).

Why should you go to the training?

Since risk is a part of doing business, it is now imperative that every company or organization have some level of risk management as a fundamental component of patient and production management. Additionally, as ICH Q9 is now essential in the health sector, risk managers and other decision-makers should receive training in risk management and asset control. Additionally, the training will arm participants with skills to facilitate decision-making, enabling them to use resources effectively and competently.

Introduction

Greetings and welcome to the Quality Risk Management Training. Here, we will explore the nuances of risk management in the context of quality assurance. Organizations in a variety of industries confront dynamic problems in a constantly changing environment, which calls for a proactive and methodical approach to quality risk. This extensive training program is intended to give you the skills, techniques, and information required to overcome these obstacles and promote a continuous improvement culture.

Participants will be prepared to proactively identify, evaluate, and manage risks by the end of this quality risk management training, guaranteeing the continuous provision of high-quality goods and services. Additionally, you will help create an organization that is resilient enough to change with the times and succeed in the long run.

We are The Training Bee, a global training and education firm providing services in many countries. We are specialized in capacity building and talent development solutions for individuals and organizations, with our highly customized programs and training sessions.

Prepare to explore the realm of superior risk management! Together, we will examine the tactics and best practices that will enable you to confidently and competently negotiate the challenges of your sector.

Learning Objectives

Upon completing Quality Risk Management Training, participants will be able to:

• Discover when and how to use the systematic tools and supporting facilitation.
• Recognize how to implement ICH Q9 as necessary during periods of crises in their respective industries.
• Make use of techniques for decision-making analysis like FMEA and HACCP (Hazard Analysis Critical Control Point).
• Determine who is responsible for what in quality risk management.
• Equip yourself with instruments and materials for risk assessment and management.

Our Unique Training Methodology

This interactive course comprises the following training methods:

• Journaling – This consists of setting a timer and letting your thoughts flow, unedited and unscripted recording events, ideas, and thoughts over a while, related to the topic.
• Social learning – Information and expertise exchanged amongst peers via computer-based technologies and interactive conversations including Blogging, instant messaging, and forums for debate in groups.
• Project-based learning
• Mind mapping and brainstorming – A session will be carried out between participants to uncover unique ideas, thoughts, and opinions having a quality discussion.
• Interactive sessions – The course will use informative lectures to introduce key concepts and theories related to the topic.
• Presentations – Participants will be presented with multimedia tools such as videos and graphics to enhance learning. These will be delivered engagingly and interactively.

Training Medium

This Quality Risk Management Training is designed in a way that it can be delivered face-to-face and virtually.

Course Duration

This training is versatile in its delivery. The training can be delivered as a full-fledged 40-hour training program or a 15- hours crash course covering 5 hours of content each day over 3 days

Pre-course Assessment

Before you enroll in this course all we wanted to know is your exact mindset and your way of thinking.
For that, we have designed this questionnaire attached below.

• Give an explanation of quality risk management and its significance for different sectors.
• Determine the essential elements of a system for managing quality risks.
• Enumerate and describe the pertinent legal requirements or industry standards that pertain to quality risk management.
• Talk about the repercussions of breaking quality requirements.
• Explain the steps involved in identifying hazards within the framework of quality management.
• Describe the various methods used to evaluate the likelihood and seriousness of hazards that have been discovered.
• Talk about the concepts of risk prioritizing and ranking.
• Describe the steps that can be taken to reduce quality risks in a production or service setting.

Course Modules

This Quality Risk Management Training covers the following topics for understanding the essentials of the Agile Workplace:

Module 1 – Hazard and Risk

• What Does a Hazard Mean?
• Describing what a Risk is.
• Describe risk management.

Module 2 – Risk Types

• Risks Associated with Operations
• Interest Rate Hazards
• Risks to Business
• Take Strategic Risks
• Risks in the Market

Module 3 – Avoidance and Evaluation of Risks

• Hazards that are foreshadowed
• Identification and detection of risks
• Finding a possible victim
• Steps and measures to safeguard the target

Module 4 – Techniques for Risk Assessment

• What-if investigation
• Bow Tie for Incident
• Hazard operability analysis, or HAZOP
• Failure mode and event analysis, or FMEA

Module 5 – Methodical

• Risk Assessment
• Examination of Risks
• Precautions Against Risk
• Tree of Decision Analysis

Module 6 – Monitoring and Keeping Up with Control Measures

• Procedures
• Training
• Supervision

Module 7 – Techniques for Risk Management

• Cut Down on the Danger
• Shift the Risk
• Steer clear of the risk.
• Recognize the Risk
• Control the Risk

Module 8 – Reporting and General Office Safety

• Reports on Accidents
• Response Strategy for Accidents
• Emergency Procedure
• Instruction & Training

Module 9 – Analysis of Business Impact

• Assemble information
• Determine Weaknesses
• Examine the Data
• Put Suggestions into Practice

Post-course Assessment

Participants need to complete an assessment post-course completion so our mentors will get to know their understanding of the course. A mentor will also have interrogative conversations with participants and provide valuable feedback.

• Explain how you would identify, evaluate, and reduce risks in a real-world scenario using the principles of quality risk management.
• Provide an overview of any modifications to standards or regulations pertaining to quality risk management that you have studied throughout the course.
• Describe how these modifications might affect the risk management strategy used by your company.
• Analyze and contrast the various risk assessment methods that were covered in the training. Give instances of when you might use each strategy most effectively.
• Showcase the proper way to keep and document records pertaining to the risk management procedure.
• Talk about how crucial proper documentation is to maintaining traceability and openness.
• Using a simulated quality issue, apply root cause analysis and describe the actions you would take to find the causes.

Lessons Learned

Holistic Understanding of Quality Risk: Having realized that quality risk encompasses all aspects of organizational operations and goes beyond compliance, participants have gained a holistic understanding of quality risk. Quality risk is increasingly seen as a crucial component of decision-making and a catalyst for ongoing development.

The training placed a strong emphasis on the fundamental role that regulatory compliance plays in high-quality risk management. The importance of fully comprehending the rules and guidelines that apply is now recognized by the participants, who also realize that following them is essential to preserving the integrity of the goods and services.

Methodologies for Dynamic Risk Assessment: Participants have become proficient in using a variety of risk assessment methodologies. The dynamic nature of risk was emphasized in the course, emphasizing the need for companies to use a variety of methods in order to properly analyze and prioritize risks.

Root Cause Analysis for Sustainable Solutions: It became clear how important root cause analysis is for dealing with quality-related problems. The participants have gained an understanding of the necessity of locating and resolving issues at their core in order to put long-term, preventative solutions into action.