Day 1

8:00 – 8:30 AM: Registration

           
8:30 – 10:00AM: REGULATORY REQUIREMENTS ON  RISK MANAGEMENT

·         Risk Management Principles

·         Developing Risk Acceptance Criteria

·         Risk Analysis Using the Preliminary Hazard Analysis

·         Assessing the Risk

·         Mitigating risks using world class practices

·         Risk Evaluation

·         Managing residual risks

10:00 – 10:15AM: Break

10:15 – 12:00 noon:PARADIGMS FOR EFFECIENCY AND COST REDUCTION

·         Management Responsibility

·         Theory of Profound Knowledge

·         Six Most Widely Used Paradigms

·         Elegant Problem Solving

·         Always Compare Life Cycle Costs to See the Cost Savings

·         Case Histories of Efficient Management

12:00 – 12:45PM: Lunch

12:45 – 2:15PM:EFFICIENCY IN RISK ANALYSIS

·         Identifying Known Risks

·         Conducting Preliminary Hazard Analysis (PHA) to Assess Risks

·         Conducting Failure Mode and Effects Analysis

·         Group Exercise on Preliminary Hazard Analysis

·         Group Exercise on Failure Mode and Effects Analysis

2:15 – 2:30AM: Break

2:30 – 4:00PM:IDENTIFYING UNKOWN RISKS

·         Negative requirements Analysis for Worst Case Scenarios

·         Fault Tree Analysis

·         Customer Surveys

·         Analysis of Manufacturing Processes

·         Group Exercise on Fault Tree Analysis

Day 2  

8:30 – 10:00AM:RISK MANAGEMENT PLAN

·         FDA Guidance on Risk Management Plan

·         Components of Risk Management Plan

·         Level of Details Needed

·         Integration into Risk Management File

·         Time Schedules

·         Controlling Plan Changes

·         Integrating Plan into Product Development

·         Auditing Risk Management File

10:00 – 10:15AM: Break

10:15 – 12:00 noon:RISK CONTROL AND RISK EVALUATION

·         FDA Risk Control Protocols

·         Thorough Risk Control Strategies

·         Risk Evaluation Process When in Doubt

·         Examples of Risk Elimination Altogether

·         Examples of Fail Safe Control

·         Examples of Effective Training

·         Group Exercise on Risk Control

12:00 – 12:45PM: Lunch

12:45 – 2:15PM:VERIFICATION AND VALIDATION OF RISK CONTROLS

• FDA Requirements for Documentation
• Verification of Risk Control During Design and Manufacturing Planning
• Validation of Design Risks
• Validation of Manufacturing Risks

2:15 – 2:30AM: Break

2:30 – 3:30PM:RISK MANAGEMT REPORTS

• Contents of Reports
• Limitations and Assumptions
• Addressing Newly Discovered Risks
• Summary of the Controls
• Summary of Residual Risk Actions