Belgian gxp forum, 7 Sep 2016
•Download as DOCX, PDF•
0 likes•233 views
The hugely successful forum was supported by the Belgian Monitoring Authorities (BMA), and co-hosted by the Belgian GLP Forum (BGF) and RQA.
Report
Share
Report
Share
Recommended
Outsourcing In Financial Services Regulatory Compliance
If you're a Supply Chain, Procurement Management or Risk Management professional working in Financial Services join us in understanding the regulatory requirements when Outsourcing and explore the processes that will support compliance with the regulations
The Learning Content Management Repository Virtual Environment system 2.0 and...
Extended introduction to "The Learning Content Management Repository Virtual Environment system 2.0 and its future" session at CETIS 2008 Conference.
LOA2020 OAPEN
Workshop: Kvalitetsgranskning och publicering av öppet tillgängliga vetenskapliga böcker
Eelco Ferwerda, OAPEN
Jisc Monitor Pilot Project: an exploration of how a Jisc managed shared servi...
Jisc Monitor Pilot Project: an exploration of how a Jisc managed shared service might support institutions in meeting the post-2014 REF Open Access policy, Brian Mitchell & Owen Stephens, Jisc
Workplan Agrologistic Forum 2015
The document proposes organizing an Agro-Logistics Forum in Cairo on November 25, 2014 to discuss opportunities in the agricultural logistics sector in Egypt. It outlines the forum's added value in detecting business opportunities, sharing good practices, and expanding business contacts. The proposed organization would have an open membership and industry chair, and be facilitated by the Dutch Embassy. The proposed 2015 workplan includes distributing a questionnaire, two plenary meetings with Dutch experts, and supporting small studies and pilot projects defined by member companies, such as on logistics losses, multimodal transport, and cold chain issues.
TCI 2016 Learnings from Catalonia
This document summarizes Catalonia's cluster policy approach over the past 25 years. The policy has evolved through four phases since 1993, with a current focus on microclusters, internal skill development, project diversification, and policy innovation. Key elements of the Catalan approach include fostering strategic change using Porter's analysis tools, public-private partnerships, cross-sectoral cooperation, and continuous improvement through learning by doing. The cluster program has helped over 2,100 members in 30 clusters and led to increased turnover, employment, and dialogue between government and the private sector. Main lessons learned are that clusters require customized approaches within a common framework and that people are key to successful clustering.
Document Control in FDA Regulated Environments - When and how to automate
Part 2 of our webinar series on how and when to automate your Paper Based Quality Management and Document Control System
A guide to lateral flow immunoassay development
This latest presentation on lateral flow immunoassay development will provide a general overview of lateral flow assays, take you through the components of a typical lateral flow test strip, and will provide you with detail on the different detection methods which are employed. We will also describe how our products and custom services can greatly simplify the development of your lateral flow assay.
To find out more about Innova Biosciences' lateral flow assay development services visit our website:
https://www.innovabiosciences.com/b2b/lateral-flow-assay-development-service.html
Recommended
Outsourcing In Financial Services Regulatory Compliance
If you're a Supply Chain, Procurement Management or Risk Management professional working in Financial Services join us in understanding the regulatory requirements when Outsourcing and explore the processes that will support compliance with the regulations
The Learning Content Management Repository Virtual Environment system 2.0 and...
Extended introduction to "The Learning Content Management Repository Virtual Environment system 2.0 and its future" session at CETIS 2008 Conference.
LOA2020 OAPEN
Workshop: Kvalitetsgranskning och publicering av öppet tillgängliga vetenskapliga böcker
Eelco Ferwerda, OAPEN
Jisc Monitor Pilot Project: an exploration of how a Jisc managed shared servi...
Jisc Monitor Pilot Project: an exploration of how a Jisc managed shared service might support institutions in meeting the post-2014 REF Open Access policy, Brian Mitchell & Owen Stephens, Jisc
Workplan Agrologistic Forum 2015
The document proposes organizing an Agro-Logistics Forum in Cairo on November 25, 2014 to discuss opportunities in the agricultural logistics sector in Egypt. It outlines the forum's added value in detecting business opportunities, sharing good practices, and expanding business contacts. The proposed organization would have an open membership and industry chair, and be facilitated by the Dutch Embassy. The proposed 2015 workplan includes distributing a questionnaire, two plenary meetings with Dutch experts, and supporting small studies and pilot projects defined by member companies, such as on logistics losses, multimodal transport, and cold chain issues.
TCI 2016 Learnings from Catalonia
This document summarizes Catalonia's cluster policy approach over the past 25 years. The policy has evolved through four phases since 1993, with a current focus on microclusters, internal skill development, project diversification, and policy innovation. Key elements of the Catalan approach include fostering strategic change using Porter's analysis tools, public-private partnerships, cross-sectoral cooperation, and continuous improvement through learning by doing. The cluster program has helped over 2,100 members in 30 clusters and led to increased turnover, employment, and dialogue between government and the private sector. Main lessons learned are that clusters require customized approaches within a common framework and that people are key to successful clustering.
Document Control in FDA Regulated Environments - When and how to automate
Part 2 of our webinar series on how and when to automate your Paper Based Quality Management and Document Control System
A guide to lateral flow immunoassay development
This latest presentation on lateral flow immunoassay development will provide a general overview of lateral flow assays, take you through the components of a typical lateral flow test strip, and will provide you with detail on the different detection methods which are employed. We will also describe how our products and custom services can greatly simplify the development of your lateral flow assay.
To find out more about Innova Biosciences' lateral flow assay development services visit our website:
https://www.innovabiosciences.com/b2b/lateral-flow-assay-development-service.html
Document Control in Regulated FDA Environments - When and how to stick with p...
Learn about When and how to use paper to your advantage in a regulated environment in theis presentation by Melita Ball and ZenQMS
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot Program
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
GLP-vs-GMP-vs-GCP Comparasation
This document provides an overview of key differences between Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP). GLPs regulate non-clinical safety studies and ensure reliability and integrity of test data. GMPs govern pharmaceutical manufacturing and quality control. GCPs provide standards for clinical trials involving human subjects to protect rights and welfare. While the principles have overlapping goals of quality and compliance, they apply to distinct phases of research and product development.
manufacturing company audit
The document outlines the audit process for a manufacturing company. It discusses the qualities needed for auditors, including knowledge of relevant laws and accounting standards as well as personal qualities like integrity and independence. It then describes the typical steps in a manufacturing company audit, which includes defining the audit scope, evaluating internal controls, examining evidence, and reporting. Special audit considerations for manufacturing include verification of work-in-progress, consignment agreements, and goods held on approval.
Quality Management Systems that Comply with ISO13485:2016
This document provides information about a presentation on quality management systems that comply with ISO 13485:2016. The presentation will be led by Lena Cordie, who has over 20 years of experience in quality and project management for medical device companies. The presentation will provide an overview of ISO 13485:2016 requirements and help companies understand how to implement quality management systems that achieve compliance. It will also discuss changes from the previous version of the standard and address related standards and regulations from FDA and EU. The target audience includes executives and managers in quality, regulatory, and other relevant roles for medical device companies.
ISO13485 : 2016 Quality Management Systems
Attend this webinar to understand how to demonstrate compliance to regulations with an ISO 13485 Quality Management System. Register Fast.
Meet You GxP Compliance in the Cloud
The ability to effectively maintain compliance while operating in the cloud has become critical to Life Sciences organizations.
Learn more about the advantages, challenges and benefits of operating in the cloud in this eBook:
Accelerate Your GxP Compliance in the Cloud: What to Expect From Your Technology Provider
Read More: http://ap.pn/2fFlCj0
Specific Detailed Changes to the New ISO 13485:2016
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
Gmp change control by amsavel
The document discusses change control management according to cGMP guidelines. It defines change control and why it is important to have a formal change control system to evaluate any changes that could affect product quality. It provides details on how to classify, document, review and approve changes, as well as testing and validation requirements. Specific guidance is given for process, equipment, raw material and analytical method changes.
Change control
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
Environmental audit
- A soft drink manufacturing company in Kerala, India began dumping foul-smelling waste slurry onto nearby land in 2002, contaminating the local water supply and affecting over 1,000 families in surrounding villages within a 5 km radius.
- The local tribal communities have been peacefully protesting to demand that the factory be closed, as it produces over 39 lakh ml of beverages daily.
- While the slurry was initially sold as fertilizer, buyers stopped purchasing it once they realized it was contaminated, so the company began dumping it illegally.
Understanding the New ISO 13485:2016 Revision
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
ISO 9001:2015 Awareness
ISO 9001:2015 Awareness Presentation
Provide insight of ISO 9001:2015 standard practice and benefits.
Introduction to GMP Training by
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
Colloids By Sitwat Rafi
Colloids are mixtures where one substance is microscopically dispersed throughout another. They consist of two phases - a dispersed phase made of very tiny particles 1nm to 1um in size suspended in a continuous dispersion medium. Common examples are milk, fog, and blood. Colloids can be classified based on the physical state of the phases and the interactions between them. Preparation methods include mechanical grinding, electrical dispersion, peptization of precipitates, and condensation by changes in conditions. The interactions between colloidal particles, such as excluded volume repulsion, electrostatic forces, van der Waals forces, and steric effects influence colloid stability and properties.
CAPA Training Presentation
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
GMP Training: Handling of deviation
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
CAPA, Root Cause Analysis and Risk Management
This document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It describes CAPA and its regulatory requirements. Various tools for root cause analysis are explained, including the five whys technique, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. FMEA involves calculating a risk priority number to identify high-risk failures for corrective action. The document emphasizes the importance of identifying root causes of problems in order to implement effective preventative actions and reduce risks.
Root Cause Analysis (RCA) Tools
This document provides an overview of root cause analysis (RCA) and common RCA tools. It discusses the CPAR/SCPAR process for documenting problems, determining root causes, and implementing corrective actions. Three common RCA tools are described: 5 Why's analysis involves repeatedly asking why to drill down to the root cause; affinity diagrams group related causes to identify major causes; and fishbone diagrams illustrate the relationship between causes and effects. The document encourages using the appropriate tool based on the problem complexity and provides examples of applying each tool.
ISO 9001:2015 Revision Overview: part 2
ISO 9001:2015 revision webinar Part 2 presentaiton slides focusing on the areas of change within the revision of the standard.
ICIC 2015 - The final Programme
ICIC 2015 - The Meeting
ICIC is the International Conference on Trends for Scientific Information Professionals.
27th ICIC International Conference for the Information Community
For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 160 attendees from the main sci-tech companies and information, service and software providers.
Started in 1989 ...
These exciting and highly respected annual conferences, that started in Montreux in 1989 and subsequently were held in Annecy, Nîmes, Barcelona, Nice, Vienna, Berlin and Heidelberg have always been a proven barometer as to the strengths and frailties of the world of sci-tech and patent information.
The conference lasts for two days and features approximately 20 formal presentations, panels on topical matters, all interspersed with short new product information presentations. All sessions are plenary. The conference begins with a reception on the first evening to enable attendees to begin networking with each other. Lunches are provided at the conference venue, and breaks are designed to facilitate networking and interaction. A focused exhibition of approximately 18 stands is integrated within the conference. Attendance at these meetings is highly international, with no one nationality predominating.
The 2015 ICIC conference is organised by Dr Haxel Congress and Event Management.
Subject Areas for the 2015 Programme
The traditional focus of the ICIC programmes is subjects of interest to information professionals in a scientific or technical environment. As in previous years, this year's programme contains a number of presentations examining aspects of patent information retrieval, including drug discovery; patent information presents many challenges and is thus an excellent test-bed when it comes to information technology. The ICIC meeting's roots in chemical information also ensure that area features prominently; chemical information was one of the first fields to attract modern information technologies back at the end of the twentieth century and the very beginning of the twentyfirst.
Next ICIC: 19 - 20 October 2015, Nice, France.
CORBEL BBMRI-ERIC QM webinar slides
Increasing demand and the use of high-quality samples, data and services place biobanks at the center of basic and applied research. The BBMRI-ERIC Quality Management Service (BBMRI.QM) is designed to help biobanks and researchers meet the highest quality standards for their research and meet the needs of their clients. This webinar will give you an insight into the service portfolio of BBMRI.QM and an overview of relevant European and international standards useful for research on human specimens.
CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research.
This webinar took place on 6th December 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website:
https://www.corbel-project.eu/webinars/bbmri-eric-quality-management-services.html
For previous and upcoming CORBEL webinars see:
http://www.corbel-project.eu/webinars
More Related Content
Viewers also liked
Document Control in Regulated FDA Environments - When and how to stick with p...
Learn about When and how to use paper to your advantage in a regulated environment in theis presentation by Melita Ball and ZenQMS
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot Program
This presentation provides an update on the progress of the Pilot and explores how the results of audits will be used by the participating Regulatory Authorities in support of market authorisation within their jurisdictions.
GLP-vs-GMP-vs-GCP Comparasation
This document provides an overview of key differences between Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP). GLPs regulate non-clinical safety studies and ensure reliability and integrity of test data. GMPs govern pharmaceutical manufacturing and quality control. GCPs provide standards for clinical trials involving human subjects to protect rights and welfare. While the principles have overlapping goals of quality and compliance, they apply to distinct phases of research and product development.
manufacturing company audit
The document outlines the audit process for a manufacturing company. It discusses the qualities needed for auditors, including knowledge of relevant laws and accounting standards as well as personal qualities like integrity and independence. It then describes the typical steps in a manufacturing company audit, which includes defining the audit scope, evaluating internal controls, examining evidence, and reporting. Special audit considerations for manufacturing include verification of work-in-progress, consignment agreements, and goods held on approval.
Quality Management Systems that Comply with ISO13485:2016
This document provides information about a presentation on quality management systems that comply with ISO 13485:2016. The presentation will be led by Lena Cordie, who has over 20 years of experience in quality and project management for medical device companies. The presentation will provide an overview of ISO 13485:2016 requirements and help companies understand how to implement quality management systems that achieve compliance. It will also discuss changes from the previous version of the standard and address related standards and regulations from FDA and EU. The target audience includes executives and managers in quality, regulatory, and other relevant roles for medical device companies.
ISO13485 : 2016 Quality Management Systems
Attend this webinar to understand how to demonstrate compliance to regulations with an ISO 13485 Quality Management System. Register Fast.
Meet You GxP Compliance in the Cloud
The ability to effectively maintain compliance while operating in the cloud has become critical to Life Sciences organizations.
Learn more about the advantages, challenges and benefits of operating in the cloud in this eBook:
Accelerate Your GxP Compliance in the Cloud: What to Expect From Your Technology Provider
Read More: http://ap.pn/2fFlCj0
Specific Detailed Changes to the New ISO 13485:2016
Today's medical device regulatory environment is changing faster than ever. Keeping up can be daunting. The new quality management standard ISO 13485:2016 was published in Q1 of 2016.
greenlight.guru has partnered with special guest and consultant, Mark Swanson, to keep you ahead of these changes.
Mark spent the last 4 years on the working group that revised the new ISO 13485.
Mark has all the exclusive insider knowledge on the changes you want. And he's going to be sharing it with you for free.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-changes)
In this webinar you'll learn specifically:
-How to prepare for the coming regulatory changes with ISO 13485:2016
-How to apply risk based thinking to your quality processes to ensure compliance
-What you need to know about the design control updates
-How to incorporate ISO 9001:2015 and 13485:2016 to your supplier controls
-A general overview of the standard and its most significant changes (before anyone else)
Gmp change control by amsavel
The document discusses change control management according to cGMP guidelines. It defines change control and why it is important to have a formal change control system to evaluate any changes that could affect product quality. It provides details on how to classify, document, review and approve changes, as well as testing and validation requirements. Specific guidance is given for process, equipment, raw material and analytical method changes.
Change control
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
Environmental audit
- A soft drink manufacturing company in Kerala, India began dumping foul-smelling waste slurry onto nearby land in 2002, contaminating the local water supply and affecting over 1,000 families in surrounding villages within a 5 km radius.
- The local tribal communities have been peacefully protesting to demand that the factory be closed, as it produces over 39 lakh ml of beverages daily.
- While the slurry was initially sold as fertilizer, buyers stopped purchasing it once they realized it was contaminated, so the company began dumping it illegally.
Understanding the New ISO 13485:2016 Revision
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
ISO 9001:2015 Awareness
ISO 9001:2015 Awareness Presentation
Provide insight of ISO 9001:2015 standard practice and benefits.
Introduction to GMP Training by
This document provides an introduction and overview of Good Manufacturing Practices (GMPs). It discusses the history and importance of GMPs in ensuring drug safety. GMPs are regulations followed by pharmaceutical companies and enforced by government agencies to ensure consistency and quality in manufacturing. The document outlines the key aspects of GMPs, including requirements for facilities, equipment, personnel, sanitation, materials testing, manufacturing controls, quality control, documentation, and specific rules for sterile products.
Colloids By Sitwat Rafi
Colloids are mixtures where one substance is microscopically dispersed throughout another. They consist of two phases - a dispersed phase made of very tiny particles 1nm to 1um in size suspended in a continuous dispersion medium. Common examples are milk, fog, and blood. Colloids can be classified based on the physical state of the phases and the interactions between them. Preparation methods include mechanical grinding, electrical dispersion, peptization of precipitates, and condensation by changes in conditions. The interactions between colloidal particles, such as excluded volume repulsion, electrostatic forces, van der Waals forces, and steric effects influence colloid stability and properties.
CAPA Training Presentation
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
GMP Training: Handling of deviation
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
CAPA, Root Cause Analysis and Risk Management
This document discusses various quality management tools used for corrective and preventative action (CAPA), including root cause analysis. It describes CAPA and its regulatory requirements. Various tools for root cause analysis are explained, including the five whys technique, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. FMEA involves calculating a risk priority number to identify high-risk failures for corrective action. The document emphasizes the importance of identifying root causes of problems in order to implement effective preventative actions and reduce risks.
Root Cause Analysis (RCA) Tools
This document provides an overview of root cause analysis (RCA) and common RCA tools. It discusses the CPAR/SCPAR process for documenting problems, determining root causes, and implementing corrective actions. Three common RCA tools are described: 5 Why's analysis involves repeatedly asking why to drill down to the root cause; affinity diagrams group related causes to identify major causes; and fishbone diagrams illustrate the relationship between causes and effects. The document encourages using the appropriate tool based on the problem complexity and provides examples of applying each tool.
ISO 9001:2015 Revision Overview: part 2
ISO 9001:2015 revision webinar Part 2 presentaiton slides focusing on the areas of change within the revision of the standard.
Viewers also liked (20)
Document Control in Regulated FDA Environments - When and how to stick with p...
Document Control in Regulated FDA Environments - When and how to stick with p...
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot Program
Presentation: Medical Devices Single Audit Program (MDSAP) Pilot Program
Quality Management Systems that Comply with ISO13485:2016
Quality Management Systems that Comply with ISO13485:2016
Specific Detailed Changes to the New ISO 13485:2016
Specific Detailed Changes to the New ISO 13485:2016
Similar to Belgian gxp forum, 7 Sep 2016
ICIC 2015 - The final Programme
ICIC 2015 - The Meeting
ICIC is the International Conference on Trends for Scientific Information Professionals.
27th ICIC International Conference for the Information Community
For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 160 attendees from the main sci-tech companies and information, service and software providers.
Started in 1989 ...
These exciting and highly respected annual conferences, that started in Montreux in 1989 and subsequently were held in Annecy, Nîmes, Barcelona, Nice, Vienna, Berlin and Heidelberg have always been a proven barometer as to the strengths and frailties of the world of sci-tech and patent information.
The conference lasts for two days and features approximately 20 formal presentations, panels on topical matters, all interspersed with short new product information presentations. All sessions are plenary. The conference begins with a reception on the first evening to enable attendees to begin networking with each other. Lunches are provided at the conference venue, and breaks are designed to facilitate networking and interaction. A focused exhibition of approximately 18 stands is integrated within the conference. Attendance at these meetings is highly international, with no one nationality predominating.
The 2015 ICIC conference is organised by Dr Haxel Congress and Event Management.
Subject Areas for the 2015 Programme
The traditional focus of the ICIC programmes is subjects of interest to information professionals in a scientific or technical environment. As in previous years, this year's programme contains a number of presentations examining aspects of patent information retrieval, including drug discovery; patent information presents many challenges and is thus an excellent test-bed when it comes to information technology. The ICIC meeting's roots in chemical information also ensure that area features prominently; chemical information was one of the first fields to attract modern information technologies back at the end of the twentieth century and the very beginning of the twentyfirst.
Next ICIC: 19 - 20 October 2015, Nice, France.
CORBEL BBMRI-ERIC QM webinar slides
Increasing demand and the use of high-quality samples, data and services place biobanks at the center of basic and applied research. The BBMRI-ERIC Quality Management Service (BBMRI.QM) is designed to help biobanks and researchers meet the highest quality standards for their research and meet the needs of their clients. This webinar will give you an insight into the service portfolio of BBMRI.QM and an overview of relevant European and international standards useful for research on human specimens.
CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research.
This webinar took place on 6th December 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website:
https://www.corbel-project.eu/webinars/bbmri-eric-quality-management-services.html
For previous and upcoming CORBEL webinars see:
http://www.corbel-project.eu/webinars
CKB-Workshop-2015-Report
This document summarizes the discussions and conclusions from the 2015 Climate Knowledge Brokers Group workshop. The workshop had over 58 participants and aimed to get feedback on a new CKB Manifesto explaining the importance of climate knowledge brokering. Participants provided valuable input on what users need, how to improve knowledge brokering, and principles for the Manifesto. An outreach event the day before featured presentations from knowledge brokers and a panel discussion on creating an effective climate knowledge grid, generating interest from an online audience. The wealth of feedback will be used to finalize the Manifesto ahead of the COP21 climate conference in Paris.
ICIC 2015 20 -20 October - The International Conference on Trends for Scienti...
27th ICIC International Conference for the Information Community For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 160 attendees from the main sci-tech companies and information, service and software providers.
Food Safety 2016 new brouchure
This document provides information about the 2nd International Conference on Food Safety and Regulatory Measures being held June 6-8, 2016 in London, UK. The conference will include keynote lectures, oral and poster presentations on various topics related to food safety. Registration options include e-posters, student delegates, and group registrations. There will be best poster and young researcher awards. Speakers will discuss topics like food safety regulations, food quality and processing, and food security. The deadline for abstract submissions is March 30, 2016.
Harro von Blotnitz
Professor von Blottnitz is an expert in life cycle assessment and renewable energy. He has extensive experience researching and supervising students on topics related to life cycle management, renewable energy sources, and waste management. He discussed how conducting a life cycle assessment requires significant data collection and highlighted challenges with a lack of regionalized data sources for South Africa. He is leading a project to develop life cycle inventory data sets for key South African industries to improve the availability and reliability of data for conducting life cycle assessments locally.
ICIC 2014 in Heidelberg
ICIC is the International Conference on Trends for Scientific Information Professionals.
26th ICIC International Conference for the Information Community
For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 160 attendees from the main sci-tech companies and information, service or software providers.
Started in 1989 ... These exciting and highly respected annual conferences, that started in Montreux in 1989 and were subsequently held in Annecy, Nîmes, Barcelona, Nice, Vienna and Berlin have always provided a barometer as to the strengths and frailties of the world of sci-tech and patent information.
The conference lasts for two and a half days and features approximately 24 formal presentations, panels on topical matters, all interspersed with short new product information presentations. All sessions are plenary. The conference normally begins with a reception and Welcome Dinner on the first evening to enable attendees to begin to network with each other. Lunches are taken at the conference venue, and breaks are designed to facilitate networking and interaction. A focused exhibition of approximately 25 stands is integrated within the conference. Attendance at these meetings is highly international, with no one nationality predominating.
The 2014 ICIC conference is organised by Dr Haxel Congress and Event Management.
Subject Areas for the 2014 Programme
The traditional focus of the ICIC programmes is subjects of interest to information professionals in a scientific or technical environment. As in previous years, this year's programme contains a number of presentations examining aspects of patent information retrieval, including drug discovery; patent information presents many challenges and is thus an excellent test-bed when it comes to information technology. The ICIC meeting's roots in chemical information also ensure that that area features prominently; chemical information was one of the first fields to attract modern information technologies back at the end of the twentieth century and the very beginning of the twentyfirst.
29th ICIC International Conference for the Information Community
ICIC is the International Conference on Trends for Scientific Information Professionals.
29th ICIC International Conference for the Information Community
For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 100 attendees from the main sci-tech companies and information, service or software providers. It will be a venue where attendees will learn about new ways to work with disseminate scientific and patent information.
Started in 1989 ...
These exciting and highly respected annual conferences, that started in Montreux in 1989 and were subsequently held in Annecy, Nîmes, Barcelona, Nice, Vienna and Berlin have always provided a barometer as to the strengths and frailties of the world of sci-tech and patent information.
The conference lasts for two days and features approximately 24 formal presentations, panels on topical matters, all interspersed with short new product information presentations. All sessions are plenary. The conference normally begins with a reception and Welcome Dinner on the first evening to enable attendees to begin to network with each other. Lunches are taken at the conference venue, and breaks are designed to facilitate networking and interaction. A focused exhibition of approximately 20 stands is integrated within the conference. Attendance at these meetings is highly international, with no one nationality predominating.
The 2017 ICIC conference is organised by Dr Haxel Congress and Event Management.
Subject Areas for the 2017 Programme
The traditional focus of the ICIC programmes is subjects of interest to information professionals in a scientific or technical environment. As in previous years, this year's programme contains a number of presentations examining aspects of patent information retrieval, including drug discovery; patent information presents many challenges and is thus an excellent test-bed when it comes to information technology. The ICIC meeting's roots in chemical information also ensure that that area features prominently; chemical information was one of the first fields to attract modern information technologies back at the end of the twentieth century and the very beginning of the twentyfirst.
Next ICIC: 23 - 24 October 2017, Heidelberg, Germany.
Location: Heidelberg Congress House
http://www.heidelberg-conventions.com/
Neckarstaden 24, 69117 Heidelberg
European bio safety association network for biosafety and biosecurity
European bio safety association network for biosafety and biosecurityEuropean Center for Disease Prevention and Control (ECDC)
The European BioSafety Association (EBSA) is a non-profit organization open to anyone working in biosafety that represents the European biosafety community. EBSA aims to establish best biosafety and biosecurity practices among its members through networking activities like training, information sharing, and advocating for emerging legislation. EBSA also works to enhance biosafety knowledge and competency through developing certification standards and curricula for biosafety professionals.GBIF Work Programme 2016 Update
This presentation summarizes the advancements towards the completing the work described in GBIF Work Programme Update 2016.
It was composed by different members from the GBIF Secretariat. This particular version was shared during the European Nodes Meeting in Lisbon the 19 April 2016.
29th ICIC International Conference for the Information Community
The document provides information about the ICIC 2017 conference which will take place on October 23-24 in Heidelberg, Germany. ICIC is the International Conference on Trends for Scientific Information Professionals which has been held annually since 1989. The conference will include approximately 24 presentations on topics related to scientific and patent information retrieval and management. It will also feature a focused exhibition and opportunities for networking.
Feeding knowlegde pre meeting
The document outlines a proposed project called "Feeding Knowledge" which aims to create an international network to promote research and innovation on food security. The project would establish an international scientific network, train young experts, develop policies to meet Third World country needs, and create an international technology platform as a hub for collaboration. The platform would collect and organize data, build knowledge, develop networks to understand and solve issues, and integrate people, tools and information through various functions and tools. The project's governance structure and costs are also summarized.
GBIF towards 2030 (November 2018)
GBIF is exploring strategies to guide its work towards 2030. Key areas of focus include:
1. Increasing engagement with the scientific community through training, tools, and enabling nodes to better support national and regional research.
2. Filling data gaps in taxonomy, geography, and time through prioritizing mobilization of new data resources and checklists.
3. Developing new infrastructure and services like data annotation, machine learning tools, and metrics to improve data quality, reuse, and support digitization of legacy collections.
Video Browser Showdown (VBS) 2012-2019
This are the slides of the keynote talk I gave at CBMI 2019 (on September 4, 2019 in Dublin, Ireland) about the Video Browser Showdown (VBS) competition.
Introduction to the COBWEB Project, January 2013
The COBWEB project is a 4-year research project starting in 2012 that aims to crowdsource environmental data to aid decision making. It will introduce quality measures to crowdsourced data and fuse it with reference data. The project will develop a citizen observatory framework and mobile data collection tools. It will have demonstrators in 3 areas - coastal monitoring, biological monitoring, and flooding - across 3 biosphere reserves in the UK, Germany and Greece. The project aims to maximize reuse of citizen observatory data within the GEOSS framework and establish guidelines for its management. It will test its approaches and disseminate results to stakeholders.
OpenAIRE - Implementing Open Science (presentation by Natalia Manola at Food ...
OpenAIRE provides services to support open science including:
1. A helpdesk that answers questions about open access policies and requirements.
2. Tools to explore and link publications, grants, and other research outputs.
3. Dashboards to help research communities monitor and connect their research outcomes.
Bioinformatics and sequencing tools used in research and development - OECD B...
24 June 2019: This OECD seminar presented and discussed the potential use of genome sequence, bioinformatic tools and databases in a regulatory decision process for microbial pesticides.
The Fertigation bible
The Fertigation bibleFERTINNOWA:Transfer of INNOvative techniques for sustainable WAter use in FERtigated crops
This document summarizes Rodney Thompson's presentation on "The Fertigation Bible". The Fertigation Bible is a comprehensive 814-page document that describes 124 fertigation technologies. It was created by 54 contributors from institutions involved in the FERTINNOWA project, with the goal of providing practical fertigation information to European horticultural stakeholders. The document is organized into chapters covering various aspects of fertigation systems and management. Each technology is described in a standard format covering its purpose, use, operation, costs and other details. The creation of The Fertigation Bible combined two tasks in the FERTINNOWA project and involved contributions from all project members to develop the technical descriptions of technologies.Biobanking 2010 Brochure
This document provides information about the upcoming Biobanking 2010 conference, including details about speakers, workshops, and topics that will be discussed. Some key points:
- The conference will take place from September 27-29, 2010 in London and will focus on advancing international R&D through effective sample management and global biobanking harmonization.
- There will be 4 pre-conference workshops covering topics like biobanking technologies, optimizing operating efficiency with IT, establishing global biobanking networks, and building internal pharmaceutical biobanks.
- The main conference over 2 days will include sessions on biobanking within pharmaceutical companies, ensuring high sample quality, integrating biobanking into biomarker research, and building
Final Programme - ICIC 2016 - 28th ICIC International Conference for the Info...
ICIC is the International Conference on Trends for Scientific Information Professionals.
28th ICIC International Conference for the Information Community
For those in the sci-tech world, sharing best practices, networking and evaluating trends have become matters of considerable importance, and the annual ICIC Meeting & Exhibition is the significant forum for this, attracting over 130 attendees from the main sci-tech companies and information, service or software providers. It will be a venue where attendees will learn about new ways to work with disseminate scientific and patent information.
Similar to Belgian gxp forum, 7 Sep 2016 (20)
ICIC 2015 20 -20 October - The International Conference on Trends for Scienti...
ICIC 2015 20 -20 October - The International Conference on Trends for Scienti...
29th ICIC International Conference for the Information Community
29th ICIC International Conference for the Information Community
European bio safety association network for biosafety and biosecurity
European bio safety association network for biosafety and biosecurity
29th ICIC International Conference for the Information Community
29th ICIC International Conference for the Information Community
OpenAIRE - Implementing Open Science (presentation by Natalia Manola at Food ...
OpenAIRE - Implementing Open Science (presentation by Natalia Manola at Food ...
Bioinformatics and sequencing tools used in research and development - OECD B...
Bioinformatics and sequencing tools used in research and development - OECD B...
Final Programme - ICIC 2016 - 28th ICIC International Conference for the Info...
Final Programme - ICIC 2016 - 28th ICIC International Conference for the Info...
Recently uploaded
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
Digital Marketing with a Focus on Sustainability
Digital Marketing best practices including influencer marketing, content creators, and omnichannel marketing for Sustainable Brands at the Sustainable Cosmetics Summit 2024 in New York
Industrial Tech SW: Category Renewal and Creation
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...❼❷⓿❺❻❷❽❷❼❽ Dpboss Kalyan Satta Matka Guessing Matka Result Main Bazar chart
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Final ank Satta Matka Dpbos Final ank Satta Matta Matka 143 Kalyan Matka Guessing Final Matka Final ank Today Matka 420 Satta Batta Satta 143 Kalyan Chart Main Bazar Chart vip Matka Guessing Dpboss 143 Guessing Kalyan night Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka➒➌➎➏➑➐➋➑➐➐Dpboss Matka Guessing Satta Matka Kalyan Chart Indian Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Indian Matka Indian satta Matka Dpboss Matka Kalyan Chart Matka Boss otg matka Guessing Satta How to Implement a Real Estate CRM Software
To implement a CRM for real estate, set clear goals, choose a CRM with key real estate features, and customize it to your needs. Migrate your data, train your team, and use automation to save time. Monitor performance, ensure data security, and use the CRM to enhance marketing. Regularly check its effectiveness to improve your business.
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
Leaders who possess self-awareness deeply understand their emotions, strengths, and weaknesses.
How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....
“After being the most listed dog breed in the United States for 31
years in a row, the Labrador Retriever has dropped to second place
in the American Kennel Club's annual survey of the country's most
popular canines. The French Bulldog is the new top dog in the
United States as of 2022. The stylish puppy has ascended the
rankings in rapid time despite having health concerns and limited
color choices.”
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Schedule Unveiled
The latest Heat Pump Manual from Newentide
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
Best practices for project execution and delivery
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership at Agile Tour Geneve 2024
Income Tax exemption for Start up : Section 80 IAC
A presentation on the concept of Exemption of Profits of Start ups from Income Tax
The Genesis of BriansClub.cm Famous Dark WEb Platform
BriansClub.cm, a famous platform on the dark web, has become one of the most infamous carding marketplaces, specializing in the sale of stolen credit card data.
Easily Verify Compliance and Security with Binance KYC
Use our simple KYC verification guide to make sure your Binance account is safe and compliant. Discover the fundamentals, appreciate the significance of KYC, and trade on one of the biggest cryptocurrency exchanges with confidence.
Digital Transformation Frameworks: Driving Digital Excellence
[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This presentation is a curated compilation of PowerPoint diagrams and templates designed to illustrate 20 different digital transformation frameworks and models. These frameworks are based on recent industry trends and best practices, ensuring that the content remains relevant and up-to-date.
Key highlights include Microsoft's Digital Transformation Framework, which focuses on driving innovation and efficiency, and McKinsey's Ten Guiding Principles, which provide strategic insights for successful digital transformation. Additionally, Forrester's framework emphasizes enhancing customer experiences and modernizing IT infrastructure, while IDC's MaturityScape helps assess and develop organizational digital maturity. MIT's framework explores cutting-edge strategies for achieving digital success.
These materials are perfect for enhancing your business or classroom presentations, offering visual aids to supplement your insights. Please note that while comprehensive, these slides are intended as supplementary resources and may not be complete for standalone instructional purposes.
Frameworks/Models included:
Microsoft’s Digital Transformation Framework
McKinsey’s Ten Guiding Principles of Digital Transformation
Forrester’s Digital Transformation Framework
IDC’s Digital Transformation MaturityScape
MIT’s Digital Transformation Framework
Gartner’s Digital Transformation Framework
Accenture’s Digital Strategy & Enterprise Frameworks
Deloitte’s Digital Industrial Transformation Framework
Capgemini’s Digital Transformation Framework
PwC’s Digital Transformation Framework
Cisco’s Digital Transformation Framework
Cognizant’s Digital Transformation Framework
DXC Technology’s Digital Transformation Framework
The BCG Strategy Palette
McKinsey’s Digital Transformation Framework
Digital Transformation Compass
Four Levels of Digital Maturity
Design Thinking Framework
Business Model Canvas
Customer Journey Map
DearbornMusic-KatherineJasperFullSailUni
My powerpoint presentation for my Music Retail and Distribution class at Full Sail University
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
Recently uploaded (20)
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Taste
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
❼❷⓿❺❻❷❽❷❼❽ Dpboss Matka Result Satta Matka Guessing Satta Fix jodi Kalyan Fin...
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
Dpboss Matka Guessing Satta Matta Matka Kalyan Chart Satta Matka
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
The Heart of Leadership_ How Emotional Intelligence Drives Business Success B...
How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....
How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Hamster Kombat' Telegram Game Surpasses 100 Million Players—Token Release Sch...
Organizational Change Leadership Agile Tour Geneve 2024
Organizational Change Leadership Agile Tour Geneve 2024
Income Tax exemption for Start up : Section 80 IAC
Income Tax exemption for Start up : Section 80 IAC
The Genesis of BriansClub.cm Famous Dark WEb Platform
The Genesis of BriansClub.cm Famous Dark WEb Platform
Easily Verify Compliance and Security with Binance KYC
Easily Verify Compliance and Security with Binance KYC
Digital Transformation Frameworks: Driving Digital Excellence
Digital Transformation Frameworks: Driving Digital Excellence
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...
Belgian gxp forum, 7 Sep 2016
- 1. 1st BELGIAN GxP FORUM: was held on 7th September 2016 @ UCB Braine l’Alleud, Belgium. “Unity is strength .... where there is teamwork and collaboration,great things can be achieved” - Mattie Stepanek The hugely successful forum was supported by the Belgian Monitoring Authorities (BMA), and co-hosted by the Belgian GLP Forum (BGF) and RQA. The desire was to create a collaborative event which provided (a) the opportunity to promote Quality, and (b) to chance for professionals to engage and share knowledge/experience in a relaxed environment - The ‘Inaugural Belgian GxP Forum’ was held on 07 Sep 2016 at the Braine UCB site. In total, 65 professionals came together from about 25 external organisations including 7 Inspectors from the Belgian Monitoring Authorities (BMA). This forum was organized as a collaborative event between Belgian GLP Forum, BMA, and RQA (www.therqa.com). The diversity of the speakers - coming from Germany, Switzerland, UK and Belgium and different work environments - provided the possibility for all of the attendees to benefit from the concentrated learning environment resulting from this event. was
- 2. Presentations detailing International Regulatory GxP updates together with Inspection Trends from the BMA were provided. In addition to these, there were presentations on current Hot Topics such as (i) Data Integrity, (ii) the new OECD Advisory Document No 17 on Computerised Systems validation, and (iii) Data process and Archiving were touched on. Furthermore, there was also mind opening topics such as (iv) Risk-based Audit Programme, (v) Transformation of a GMP Development QMS, (v) Animal Welfare topic (risk- based approach for use of non-AAALAC accredited animal providers for research work) and (vi) Allotrope foundation – (building an open framework for laboratory data). We thank UCB for providing the opportunity to host and support this memorable event. Speakers: Alastair Hughes (Covance, UK); Lee Monk (UCB); Gaetan Rygaert (UCB); Peter Esch (Novatis); Martijn Baeten (BMA); Guido Jacobs (BMA); Henning Kayser (Bayer G); Thomas Steckler (J&J)