Pideya Learning Academy

Training in Quality Risk Management Strategies

Upcoming Schedules

  • Live Online Training
  • Classroom Training

Date Venue Duration Fee (USD)
27 Jan - 31 Jan 2025 Live Online 5 Day 2750
31 Mar - 04 Apr 2025 Live Online 5 Day 2750
28 Apr - 02 May 2025 Live Online 5 Day 2750
02 Jun - 06 Jun 2025 Live Online 5 Day 2750
28 Jul - 01 Aug 2025 Live Online 5 Day 2750
29 Sep - 03 Oct 2025 Live Online 5 Day 2750
20 Oct - 24 Oct 2025 Live Online 5 Day 2750
08 Dec - 12 Dec 2025 Live Online 5 Day 2750

Course Overview

Quality Risk Management is an essential framework for organizations aiming to identify, evaluate, and mitigate potential risks while ensuring operational efficiency and regulatory compliance. In today’s fast-paced business environment, managing quality risks effectively is critical to achieving sustained growth and maintaining stakeholder trust. Pideya Learning Academy’s Training in Quality Risk Management Strategies provides a comprehensive and structured approach to mastering these vital skills, empowering professionals to make informed, strategic decisions.
The global need for effective quality risk management is evident across industries. For instance, a report by Deloitte highlights that 84% of organizations in regulated industries, such as pharmaceuticals and healthcare, face challenges related to compliance and risk assessment. Moreover, with the pharmaceutical market projected to reach USD 1.8 trillion by 2026, ensuring the safety, quality, and efficacy of products through risk management frameworks like ICH Q9 and ISO 14971 is no longer optional—it’s imperative. This demand underlines the importance of training professionals to excel in quality risk management to meet stringent industry requirements.
At Pideya Learning Academy, this training program is meticulously designed to equip participants with an in-depth understanding of risk management principles and methodologies. Participants will delve into global regulatory standards, including ICH Q9 and ISO 14971, widely regarded as the gold standard in the pharmaceutical and medical device industries. This ensures that attendees not only understand the regulatory landscape but also learn how to apply these principles effectively to safeguard their organization’s processes.
Key highlights of the program include:
Comprehensive coverage of ICH Q9 and ISO 14971 standards, enabling participants to navigate and implement internationally recognized risk management guidelines.
Mastering analytical tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Point (HACCP), ensuring participants can identify, assess, and mitigate risks in diverse scenarios.
Tailored learning aligned with real-world challenges, helping professionals develop actionable strategies and enhance their decision-making capabilities.
A systematic approach to risk evaluation and control, focusing on strategies to predict, prevent, and manage risks effectively.
Insights into global best practices for risk communication and documentation, critical for maintaining transparency and compliance.
Empowering participants with leadership skills in risk management, fostering a culture of proactive risk identification and mitigation within their organizations.
Participants will leave the program with a robust framework for evaluating risks, prioritizing mitigation measures, and driving continuous improvement in their organizations. By integrating tools like FMEA and HACCP into their workflows, they will be well-prepared to tackle the challenges of quality risk management in their respective industries.
The Training in Quality Risk Management Strategies at Pideya Learning Academy is not only relevant for those in pharmaceuticals and healthcare but also for professionals across other sectors where risk management is vital. The curriculum incorporates industry-relevant scenarios, ensuring that participants gain a well-rounded understanding of quality risk management principles applicable to their unique environments.
As organizations strive to adapt to an increasingly complex regulatory landscape, this training provides the knowledge and skills necessary to thrive. Whether it’s mitigating operational risks, addressing compliance challenges, or enhancing overall organizational performance, the tools and strategies imparted through this program are indispensable for modern businesses. With a focus on fostering expertise in risk management, Pideya Learning Academy ensures that participants are equipped to contribute significantly to their organizations’ success.
By participating in this training, attendees not only enhance their professional skill set but also position themselves as invaluable assets to their organizations. With a structured and systematic curriculum, Pideya Learning Academy is committed to delivering impactful learning experiences that drive tangible results in quality risk management.

Key Takeaways:

  • Comprehensive coverage of ICH Q9 and ISO 14971 standards, enabling participants to navigate and implement internationally recognized risk management guidelines.
  • Mastering analytical tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Point (HACCP), ensuring participants can identify, assess, and mitigate risks in diverse scenarios.
  • Tailored learning aligned with real-world challenges, helping professionals develop actionable strategies and enhance their decision-making capabilities.
  • A systematic approach to risk evaluation and control, focusing on strategies to predict, prevent, and manage risks effectively.
  • Insights into global best practices for risk communication and documentation, critical for maintaining transparency and compliance.
  • Empowering participants with leadership skills in risk management, fostering a culture of proactive risk identification and mitigation within their organizations.
  • Comprehensive coverage of ICH Q9 and ISO 14971 standards, enabling participants to navigate and implement internationally recognized risk management guidelines.
  • Mastering analytical tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Point (HACCP), ensuring participants can identify, assess, and mitigate risks in diverse scenarios.
  • Tailored learning aligned with real-world challenges, helping professionals develop actionable strategies and enhance their decision-making capabilities.
  • A systematic approach to risk evaluation and control, focusing on strategies to predict, prevent, and manage risks effectively.
  • Insights into global best practices for risk communication and documentation, critical for maintaining transparency and compliance.
  • Empowering participants with leadership skills in risk management, fostering a culture of proactive risk identification and mitigation within their organizations.

Course Objectives

After completing this Pideya Learning Academy training, participants will learn to:
Apply supporting facilitation and systematic tools for risk management.
Implement ICH Q9 standards during critical situations in their sectors.
Use decision-making tools such as HACCP and FMEA to evaluate and control risks.
Identify roles and responsibilities within a quality risk management system.
Leverage resources and tools for effective risk evaluation and mitigation.

Personal Benefits

Individuals who participate in this training will:
Gain a comprehensive understanding of quality risk management principles.
Develop skills to advance their careers in risk management.
Enhance their ability to assess and control risks effectively.
Acquire practical knowledge of tools like FMEA and HACCP.

Organisational Benefits

Who Should Attend

This training is ideal for professionals in the healthcare and pharmaceutical sectors, including:
Risk management professionals seeking to enhance their knowledge.
Employees responsible for implementing and managing risk control measures.
Senior management involved in decision-making processes related to risk.
Aspiring risk management consultants.
Organizations aiming to improve their patient-related services.
At Pideya Learning Academy, we are committed to empowering professionals and organizations with the skills and knowledge needed to excel in quality risk management.

Course Outline

Module 1: Fundamentals of Risk and Hazard
Defining Hazards Defining Risks Principles of Risk Management Hazard-Risk Relationship
Module 2: Categories of Risks
Operational and Systemic Risks Interest Rate Volatility Risks Strategic and Organizational Risks Market Dynamics and Fluctuation Risks Liquidity and Solvency Risks Legal and Regulatory Risks Political and Socioeconomic Risks Investment and Financial Exposure Risks
Module 3: Risk Prevention and Initial Assessment
Proactive Risk Anticipation Advanced Risk Detection Techniques Vulnerability Identification Protective Action Planning Risk Control Strategies Assessing Impact Severity Consequence Scaling Frameworks Advanced Risk Assessment Tools
Module 4: Advanced Risk Assessment Techniques
Event Chain Analysis Fault Tree Methodologies (FTA) Hypothetical Scenarios Analysis (What-If) Bow-Tie Method for Incident Analysis Hazard Operability Studies (HAZOP) Failure Mode and Effects Analysis (FMEA)
Module 5: Analytical Approaches to Risk Management
Continuous Risk Monitoring Frameworks Predictive Risk Analytics Strategic Risk Mitigation Techniques Decision Trees for Complex Risk Analysis
Module 6: Managing and Updating Risk Control Measures
Overview of Control Measures Standard Operating Procedures (SOPs) Comprehensive Training Programs Supervision and Oversight Mechanisms Regular Updating of Risk Controls Documentation and Maintenance
Module 7: Practical Risk Management Strategies
Risk Reduction Frameworks Risk Transfer Mechanisms Strategies for Risk Avoidance Risk Acceptance Protocols Continuous Risk Optimization Analyzing Root Causes Using Fishbone Diagram
Module 8: Workplace Safety and Incident Reporting
Comprehensive Accident Reporting Frameworks Developing an Incident Response Plan Emergency Preparedness Protocols Continuous Training and Staff Awareness Programs
Module 9: Business Resilience and Impact Analysis
Data Collection for Business Impact Assessment Identifying Key Vulnerabilities Interpreting and Analyzing Risk Data Implementing Risk Mitigation Recommendations
Module 10: Development and Execution of Recovery Plans
Designing Risk and Hazard Mitigation Plans Execution of Recovery Plans Control Plan Effectiveness Evaluation
Module 11: Comprehensive Risk Assessment Summaries
Integrating FMEA and HACCP in Risk Assessment Identifying and Classifying Hazards Assessing Potential Harm to Stakeholders Evaluating Adequacy of Current Control Measures
Module 12: Reflection and Future Action
Capturing Lessons Learned Completion and Review of Action Plans Final Evaluation and Continuous Improvement

Have Any Question?

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