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Corporate Programs
Bespoke Courses
Family Succession
Executive Succession
Investor Value Creation
Value Added Services
Managed LMS
Instructional Design
Training Calendar
Showcase
Events
Contact Us
Contact Us
Corporate Programs
Bespoke Courses
Family Succession
Executive Succession
Investor Value Creation
Value Added Services
Managed LMS
Instructional Design
Training Calendar
Showcase
Events
Contact Us
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Risk Management as a Strategic Tool to Assure Quality
Curriculum
4 Sections
16 Lessons
1 Day
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Foundations of Risk Management in Quality
4
1.1
Defining Risk Management: ICH Q9 & ISO 31000 perspectives.
1.2
Key terminologies: risk identification, assessment, mitigation, residual risk.
1.3
Role of Risk Management in Quality Systems (QMS).
1.4
Regulatory expectations (USFDA, EMA, WHO, PIC/S).
Risk Management Tools & Methodologies
4
2.1
Common tools: FMEA (Failure Mode & Effects Analysis), FTA (Fault Tree Analysis), HACCP, PHA, HAZOP.
2.2
Selecting the right tool: risk-based decision making.
2.3
Risk categorization: critical, major, minor.
2.4
Case scenarios: how tools are applied in QA, QC, manufacturing, R&D.
Real-Life Applications & Case Studies
4
3.1
Case study: Risk-based approach in cleaning validation.
3.2
Case study: Supplier qualification and raw material risks.
3.3
Case study: Product recall prevention through proactive risk control.
3.4
Lessons from regulatory audits: where risk management failed or succeeded.
Interactive Workshop & Exercises
4
4.1
Group exercise: Conducting a mini-FMEA on a manufacturing process.
4.2
Risk prioritization simulation – “critical to quality” parameters.
4.3
Designing a Risk Control Strategy: balancing compliance & efficiency.
4.4
Building a risk register for ongoing monitoring.
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