How to use Risk Based Process Safety's skills to be in compliance with ICH-Q9 "Quality Risk Management" in the Pharmaceutical Industry
About This Event
Description
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
Why Should you Attend
Currently, some health regulatory agencies around the world such as the Federal Drug Administration (FDA), Health Canada and others are requiring the pharmaceutical industry to utilize a systematic approach to the quality risk management. Having a good quality risk management program will help to improve processes in the future and have a better decision making process.
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
Who will Benefit
Quality Assurance Personnel and Management
Quality Control Personnel and Management
Manufacturing Personnel and Management
Research and Development Personnel and Management
Engineering and Maintenance Personnel and Management.
For Registration
http://www.onlinecompliancepanel.com/webinar/QUALITY-RISK-MANAGEMENT-PHARMACEUTICAL-INDUSTRY-501651/SEPTEMBER-2016-ES-WORLDCONCAL
Note: Use Promo code RGHUP and get 10% off on registration (Valid till September 30th 2016)