ISPE to Give ICH Training at Washington Conference
ISPE is to hold seven educational sessions, including two that will focus on ICH quality standards, at its 2011 Washington Conference on 6-9 June 2011 at the JW Marriott in Washington, DC. ICH Q8, Q9 and Q10 will be a primary focus of 'Addressing ICH - Robust Process Validation and Compliance Assurance Starts with Product Realization: Effectively Applying Quality by Design (PQLI)', a fundamental- to intermediate-level session that will take place on 6-7 June. This session will highlight the business value of applying quality-by-design (QbD) principles and the risks that occur when QbD is not in place.
It will also help participants to use related ISPE good-practice guides to implement QbD in their companies. 'Emerging Topics in the API Global Regulatory Environment' will focus on ICH Q11 and will take place on 8-9 June. This intermediate- to advanced-level session will feature industry and regulatory members of the ICH Q11 Expert Working Group who have authored the guideline to provide background on the origins of Q11, the key concepts contained in the guideline and the progress made towards harmonisation.
The session will prepare participants to provide informed comments on the ICH Q11 guideline when it is published for public review, incorporate principles from the guidance into the development and lifecycle management of manufacturing processes for drug substances and adopt a QbD submission to the Common Technical Document format. Another education session, entitled 'Barrier Isolation Technology Foum: Innovation, Updates, New Case Studies (20th Annual)', will present developing technology and regulatory perspectives for barrier isolation, especially in regards to advanced aseptic processing, restricted-access barrier systems (RABSs) and isolators.
In addition, as part of 'Commissioning and Qualification: Science and Risk-Based Approaches; Current Industry Experiences and New Guidance', participants will receive an overview and electronic copies of ISPE's upcoming guidance documents, 'ISPE Guide: A Science- and Risk-Based Approach for the Delivery of Facilities, Systems' and 'Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification'. A two-day session entitled 'GAMP Practical Application Case Study Workshops' will present seven hands-on workshops and will introduce two newly updated GAMP good-practice guides, 'A Risk-Based Approach to Calibration Management, Second Edition' and 'A Risk-Based Approach to GxP Process Control Systems, Second Edition'.
Participants will receive electronic copies of these documents. Next, delegates attending 'Critical Utility Systems: Implementation of Risk and Cost-Based Strategies for Design, Operation and Qualification' will learn, through real-life case studies, about novel techniques and processes to optimise critical utility systems while controlling deliverables, installation, validation and operational costs. The 'ISPE Good Practice Guide: Process Gases' will be featured and an electronic copy will be provided to registrants upon release.
A one-day session entitled 'Implementing PAT in Manufacturing Environments: Case Studies from Development to Implementation' will provide case studies from product development to regulatory submission, highlighting the development of critical process parameters using a scientific approach and the use of PAT solutions early in the process.
In addition to the educational content being presented, the 2011 Washington Conference will feature three training courses. First, 'Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline Guide' is a two-day training course that will include an overview of ICH Q9 and detail how ISPE's 'Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide' uses the concepts of the guidance to create a scientific, risk-based method to help companies to manage the risk of cross contamination. Participants will receive a copy of the guide.
Second, a course entitled 'Complying with Part 11 - Risk Management: Applying the GAMP Good Practice Guide Electronic Records and Signatures Principles' will, using the 'GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures' as a resource, give participants a practical introduction to the 21 CFR Part 11 regulation, including up-to-the-minute updates on the current FDA review of the regulation. Again, participants will receive a copy of the guide. Third, the 'HVAC for Pharmaceutical Facilities' course will provide a detailed description of HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers and filters. Participants will receive a copy of the guide.
It will also help participants to use related ISPE good-practice guides to implement QbD in their companies. 'Emerging Topics in the API Global Regulatory Environment' will focus on ICH Q11 and will take place on 8-9 June. This intermediate- to advanced-level session will feature industry and regulatory members of the ICH Q11 Expert Working Group who have authored the guideline to provide background on the origins of Q11, the key concepts contained in the guideline and the progress made towards harmonisation.
The session will prepare participants to provide informed comments on the ICH Q11 guideline when it is published for public review, incorporate principles from the guidance into the development and lifecycle management of manufacturing processes for drug substances and adopt a QbD submission to the Common Technical Document format. Another education session, entitled 'Barrier Isolation Technology Foum: Innovation, Updates, New Case Studies (20th Annual)', will present developing technology and regulatory perspectives for barrier isolation, especially in regards to advanced aseptic processing, restricted-access barrier systems (RABSs) and isolators.
In addition, as part of 'Commissioning and Qualification: Science and Risk-Based Approaches; Current Industry Experiences and New Guidance', participants will receive an overview and electronic copies of ISPE's upcoming guidance documents, 'ISPE Guide: A Science- and Risk-Based Approach for the Delivery of Facilities, Systems' and 'Equipment and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification'. A two-day session entitled 'GAMP Practical Application Case Study Workshops' will present seven hands-on workshops and will introduce two newly updated GAMP good-practice guides, 'A Risk-Based Approach to Calibration Management, Second Edition' and 'A Risk-Based Approach to GxP Process Control Systems, Second Edition'.
Participants will receive electronic copies of these documents. Next, delegates attending 'Critical Utility Systems: Implementation of Risk and Cost-Based Strategies for Design, Operation and Qualification' will learn, through real-life case studies, about novel techniques and processes to optimise critical utility systems while controlling deliverables, installation, validation and operational costs. The 'ISPE Good Practice Guide: Process Gases' will be featured and an electronic copy will be provided to registrants upon release.
A one-day session entitled 'Implementing PAT in Manufacturing Environments: Case Studies from Development to Implementation' will provide case studies from product development to regulatory submission, highlighting the development of critical process parameters using a scientific approach and the use of PAT solutions early in the process.
In addition to the educational content being presented, the 2011 Washington Conference will feature three training courses. First, 'Managing the Risk of Cross Contamination: Applying the Risk-MaPP Baseline Guide' is a two-day training course that will include an overview of ICH Q9 and detail how ISPE's 'Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) Baseline Guide' uses the concepts of the guidance to create a scientific, risk-based method to help companies to manage the risk of cross contamination. Participants will receive a copy of the guide.
Second, a course entitled 'Complying with Part 11 - Risk Management: Applying the GAMP Good Practice Guide Electronic Records and Signatures Principles' will, using the 'GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures' as a resource, give participants a practical introduction to the 21 CFR Part 11 regulation, including up-to-the-minute updates on the current FDA review of the regulation. Again, participants will receive a copy of the guide. Third, the 'HVAC for Pharmaceutical Facilities' course will provide a detailed description of HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers and filters. Participants will receive a copy of the guide.
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