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Risk-based Control Strategies in Pharmaceutical Industries at ISPE Brussels Conference
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ISPE, a global not-for-profit association of 23,000 pharmaceutical science and manufacturing professionals, will be hosting the ISPE Brussels Conference – Risk-based Control Strategies in Pharmaceutical Industries – at the Sheraton Brussels Hotel in Brussels, Belgium, 20-23 September 2010.
The ISPE Brussels Conference will be the global launch of the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP). Attendees will receive a complimentary copy of the Guide with paid registration. In preparation for the Risk-MaPP Seminar, it is encouraged that delegates attend a Live Webinar ‘Risk-MaPP: What it is and Why You Need it!’ on 14 September 2010.
Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this document is an essential tool in understanding and control the risk of cross contamination, while also protecting the operator.
The conference will provide industry professionals the opportunity to learn from leaders and innovators from across the globe. The conference seminars and training courses include:
Conference Seminars:
• Barrier Isolation Technology Forum: Innovation, Updates, New Case Studies
• Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach
• GAMP: A Guided Tour of the World of Good Practice Guides
• PQLI: Case Studies in QbD for Biotechnology and Small Molecule Product Realisation
• Containment: The Devil is in the Detail
• Investigational Products (IP): Lean and Compliant Applying Efficient Tools to a Regulated Clinical Supply Chain
View App Note / Case Study
• Science and Risk-Based Commissioning and Qualification (C&Q): Transitioning and Transforming
Training Courses
• Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
• Practical Application of Computerized Systems Compliance GAMP® 5 (includes online course)
In addition, the event will include sponsorship and tabletop exhibits of the industry’s top suppliers of pharmaceutical manufacturing, and networking events for pharmaceutical industry professionals.
The ISPE Brussels Conference will be the global launch of the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP). Attendees will receive a complimentary copy of the Guide with paid registration. In preparation for the Risk-MaPP Seminar, it is encouraged that delegates attend a Live Webinar ‘Risk-MaPP: What it is and Why You Need it!’ on 14 September 2010.
Risk-MaPP provides a scientific risk-based approach, based on ICH Q9, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. If you are involved with multi-product facilities, this document is an essential tool in understanding and control the risk of cross contamination, while also protecting the operator.
The conference will provide industry professionals the opportunity to learn from leaders and innovators from across the globe. The conference seminars and training courses include:
Conference Seminars:
• Barrier Isolation Technology Forum: Innovation, Updates, New Case Studies
• Dedicated Facilities, Cross Contamination and the Risk-MaPP Approach
• GAMP: A Guided Tour of the World of Good Practice Guides
• PQLI: Case Studies in QbD for Biotechnology and Small Molecule Product Realisation
• Containment: The Devil is in the Detail
• Investigational Products (IP): Lean and Compliant Applying Efficient Tools to a Regulated Clinical Supply Chain
Successful Scale-Up for High-Density Microbial Processes
This application note highlights the successful 5-fold scale-up of a high-cell density E. coli process from an established 200 L stainless steel fermenter to a 1000 L single-use system.View App Note / Case Study
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Training Courses
• Sterile Drug Manufacturing Facilities: Applying ISPE Baseline® Guide and FDA Guidance Principles to Design and Operation
• Practical Application of Computerized Systems Compliance GAMP® 5 (includes online course)
In addition, the event will include sponsorship and tabletop exhibits of the industry’s top suppliers of pharmaceutical manufacturing, and networking events for pharmaceutical industry professionals.
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