How to use Risk Based Process Safety's skills to be in compliance with ICH-Q9 "Quality Risk Management" in the Pharmaceutical Industry
WebcastFaculty
OVERVIEW
How to use Risk Based Process Safety's skills to be in compliance with ICH-Q9 "Quality Risk Management" in the Pharmaceutical Industry is organized by OnlineCompliancePanel and would be held on Sep 01, 2016.
This webinar will cover the similarities between the second pillar "Knowing the Process" of the Risk Based Process Safety Management and ICH-Q9 "Quality Risk Analysis". This webinar will provide the tools and help to identify the process required information to perform the quality risk by using methodologies in the process hazard analysis (PHA) to determine possible deviation during the process to achieve the good quality of the finished product.
Objectives of the Presentation :
• Similarities between 2 Pillar of the Risk Based Process Safety and ICH-Q9 'Quality Risk Management'
• Understanding of process information
• Determine the scope of the quality risk analysis
• Who participates
• Methodologies to perform the quality risk analysis such as s, fault tree analysis what if and Hazard and operability analysis (HAZOP)
• Determination of cause, consequence, safe guard, risk ranking and recommendations
• Training.
Areas Covered :
• Collection and use of process information
• Determination of Nodes
• Equipment and utilities
• HAZOP, What If and Fault tree study sessions
• Elaboration of final report and distribution
• Approval process of the quality risk analysis
• Implementation.
This webinar will cover the similarities between the second pillar "Knowing the Process" of the Risk Based Process Safety Management and ICH-Q9 "Quality Risk Analysis". This webinar will provide the tools and help to identify the process required information to perform the quality risk by using methodologies in the process hazard analysis (PHA) to determine possible deviation during the process to achieve the good quality of the finished product.
Objectives of the Presentation :
• Similarities between 2 Pillar of the Risk Based Process Safety and ICH-Q9 'Quality Risk Management'
• Understanding of process information
• Determine the scope of the quality risk analysis
• Who participates
• Methodologies to perform the quality risk analysis such as s, fault tree analysis what if and Hazard and operability analysis (HAZOP)
• Determination of cause, consequence, safe guard, risk ranking and recommendations
• Training.
Areas Covered :
• Collection and use of process information
• Determination of Nodes
• Equipment and utilities
• HAZOP, What If and Fault tree study sessions
• Elaboration of final report and distribution
• Approval process of the quality risk analysis
• Implementation.
SPECIALITIES
Risk Management and Medical NegligenceQuality Management
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