How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
Compilation of available tools and models used for assessing consumer exposur...OECD Environment
With the dramatic increase of nano-enabled products entering the market every year, human and environmental exposures are inevitable, which raises concerns in terms of the health and safety of such emerging nanomaterials. Scientific knowledge to assess the exposure to nanomaterials continues to improve. As an example, new exposure tools and models for nanomaterials are being developed.
To further promote the development in this area, the OECD compiled an inventory of available models and tools for assessing occupational, consumer and environmental exposure to Nanomaterials. 54 tools and models were initially compiled and following in-depth analyses, 10 occupational, 7 consumer and 6 environmental tools/models were recommended or evaluated as suitable for assessing exposure to nanomaterials. The detailed information on the analyses and evaluations are provided in the reports accessible from the Series on Nanomaterials website (No. 98, 99, 100 and 101).
The OECD hosted a webinar on 2 December at 14:00 CET to present the key findings of the reports. Watch the video replay at: https://oe.cd/testing-assessment-webinars
An inherent physical or chemical characteristic that has the potential for causing harm to people, the environment, or property1
Hazards are intrinsic to a material, or its conditions of use
Examples
Hydrogen sulfide – toxic by inhalation
Gasoline – flammable
Moving machinery – kinetic energy, pinch points
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
Seven questions answered by process hazard analysisPaul Baybutt
Process hazard analysis identifies hazard scenarios. It answers seven key questions to protect people, property and the environment from catastrophic accidents.
A hazard is a situation that poses a level of threat to life, health, property, or environment. Most hazards are dormant or potential, with only a theoretical risk of harm; however, once a hazard becomes "active", it can create an emergency. Hazard and possibility interact together to create risk.
Identification of hazard risks is the first step in performing a risk assessment.
With the regulators moving forward with guidance on risk based monitoring, and the industry trend of
adopting this approach, this presentation will aim to demonstrate how the combination of CTMS, EDC
and analytics can be used to identify and manage site risk profiles. The presentation will draw from the
work completed by the MCC members and show how the Site Scoring tools for Site Selection and Study
Conduct can be used to generate a risk profile dashboard based on data from CTMS and EDC. The
presentation will further explore how data captured in CTMS and EDC can be used to update the risk
profile of the site during the course of the study, allowing the study team to proactively manage risk.
A project with the aim to standardize an RBM approach in clinical trials. It unites four companies and academic organizations, focuses on the evaluation and optimization of Risk-based Monitoring (RbM). For this purpose, PUEKS will use data available from past clinical studies to select substantiated key risk indicators (KRIs). Subsequently, the obtained data-driven KRIs will be tested in an ongoing trial. A comparative evaluation with historical data from past studies will be additionally performed to evaluate the power of the selected KRIs in terms of cost savings, enhanced quality, and risk mitigation. The project is aimed at delivering a robust RbM tool as well as an optimized procedure for the successful implementation of RbM.
This project (HA project no. 448/14-38) is funded in the framework of Hessen ModellProjekte, financed with funds of LOEWE – Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz, Förderlinie 3: KMU-Verbundvorhaben (State Offensive for the Development of Scientific and Economic Excellence).
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
Learning from experience involves monitoring, and acting on,
internal and external sources of information. Despite a company’s best efforts, operations do not always proceed as planned, so organizations must be ready to turn their mistakes – and those of others – into opportunities to improve process safety efforts.
Compilation of available tools and models used for assessing consumer exposur...OECD Environment
With the dramatic increase of nano-enabled products entering the market every year, human and environmental exposures are inevitable, which raises concerns in terms of the health and safety of such emerging nanomaterials. Scientific knowledge to assess the exposure to nanomaterials continues to improve. As an example, new exposure tools and models for nanomaterials are being developed.
To further promote the development in this area, the OECD compiled an inventory of available models and tools for assessing occupational, consumer and environmental exposure to Nanomaterials. 54 tools and models were initially compiled and following in-depth analyses, 10 occupational, 7 consumer and 6 environmental tools/models were recommended or evaluated as suitable for assessing exposure to nanomaterials. The detailed information on the analyses and evaluations are provided in the reports accessible from the Series on Nanomaterials website (No. 98, 99, 100 and 101).
The OECD hosted a webinar on 2 December at 14:00 CET to present the key findings of the reports. Watch the video replay at: https://oe.cd/testing-assessment-webinars
An inherent physical or chemical characteristic that has the potential for causing harm to people, the environment, or property1
Hazards are intrinsic to a material, or its conditions of use
Examples
Hydrogen sulfide – toxic by inhalation
Gasoline – flammable
Moving machinery – kinetic energy, pinch points
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
Seven questions answered by process hazard analysisPaul Baybutt
Process hazard analysis identifies hazard scenarios. It answers seven key questions to protect people, property and the environment from catastrophic accidents.
A hazard is a situation that poses a level of threat to life, health, property, or environment. Most hazards are dormant or potential, with only a theoretical risk of harm; however, once a hazard becomes "active", it can create an emergency. Hazard and possibility interact together to create risk.
Identification of hazard risks is the first step in performing a risk assessment.
With the regulators moving forward with guidance on risk based monitoring, and the industry trend of
adopting this approach, this presentation will aim to demonstrate how the combination of CTMS, EDC
and analytics can be used to identify and manage site risk profiles. The presentation will draw from the
work completed by the MCC members and show how the Site Scoring tools for Site Selection and Study
Conduct can be used to generate a risk profile dashboard based on data from CTMS and EDC. The
presentation will further explore how data captured in CTMS and EDC can be used to update the risk
profile of the site during the course of the study, allowing the study team to proactively manage risk.
A project with the aim to standardize an RBM approach in clinical trials. It unites four companies and academic organizations, focuses on the evaluation and optimization of Risk-based Monitoring (RbM). For this purpose, PUEKS will use data available from past clinical studies to select substantiated key risk indicators (KRIs). Subsequently, the obtained data-driven KRIs will be tested in an ongoing trial. A comparative evaluation with historical data from past studies will be additionally performed to evaluate the power of the selected KRIs in terms of cost savings, enhanced quality, and risk mitigation. The project is aimed at delivering a robust RbM tool as well as an optimized procedure for the successful implementation of RbM.
This project (HA project no. 448/14-38) is funded in the framework of Hessen ModellProjekte, financed with funds of LOEWE – Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz, Förderlinie 3: KMU-Verbundvorhaben (State Offensive for the Development of Scientific and Economic Excellence).
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
Learning from experience involves monitoring, and acting on,
internal and external sources of information. Despite a company’s best efforts, operations do not always proceed as planned, so organizations must be ready to turn their mistakes – and those of others – into opportunities to improve process safety efforts.
Guidelines to Understanding Design of Experiment and Reliability Predictionijsrd.com
This paper will focus on how to plan experiments effectively and how to analyse data correctly. Practical and correct methods for analysing data from life testing will also be provided. This paper gives an extensive overview of reliability issues, definitions and prediction methods currently used in the industry. It defines different methods and correlations between these methods in order to make reliability comparison statements from different manufacturers' in easy way that may use different prediction methods and databases for failure rates. The paper finds however such comparison very difficult and risky unless the conditions for the reliability statements are scrutinized and analysed in detail.
Organizations that understand hazards and risk are better able to allocate limited resources in the most effective manner. Industry experience has demonstrated that businesses using hazard and risk information to plan, develop, and deploy stable, lower-risk operations are much more likely to enjoy long term success.
Many regulatory requires the selection and use of Best Available Technologies (BAT) that fulfil the definition of an Environmental Sound Technologies (EST’s)
To ensure compliance with the regulatory requirements project proponents must demonstrate that they have undertaken an internationally recognized and acceptable methodology for the comparative assessment of EST’s.
Therefore, project proponents must provide documented evidence of this process when seeking project approval and/or licencing.
The challenges facing in pharmaceutical maintenanceMANUEL PACINI
Maintenance strategies for the pharmaceutical industry.
Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar will shed light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
SPS'20 - Designing a Methodological Framework for the Empirical Evaluation of...Andrea Montemaggio
Presented at the 2nd International Workshop on Self-Protecting Systems (SPS'20).
Abstract:
Increasingly, cyber attacks against enterprises and governments make use of automated tools. For this reason, and given the importance of a timely protection, in the last decade there has been a push in researching methodologies to automate the full defense life-cycle of computer systems. The two core phases of this life-cycle are Intrusion Detection and Intrusion Response. However, while some progress has been done on the former, the latter is still at an early stage. This is due to several factors, among which the lack of a standardized methodology for the validation and comparison of Intrusion Response methodologies.
In this paper, we attempt to fill this gap by introducing a methodological framework for the quantitative empirical evaluation of self-protecting systems, based on the metrics of response time and cost. An experimental design is also provided and its applicability is illustrated by the means of a template experiment.
EIA and Its features, Various Methodologypatil982959
EIA: an activity designed to identify and predict the impact of project on biogeophysicochemical environment and on human health so as to recommend appropriate legislative measures, programs and operational procedures to minimize the impacts
International Journal of Engineering Research and Applications (IJERA) is an open access online peer reviewed international journal that publishes research and review articles in the fields of Computer Science, Neural Networks, Electrical Engineering, Software Engineering, Information Technology, Mechanical Engineering, Chemical Engineering, Plastic Engineering, Food Technology, Textile Engineering, Nano Technology & science, Power Electronics, Electronics & Communication Engineering, Computational mathematics, Image processing, Civil Engineering, Structural Engineering, Environmental Engineering, VLSI Testing & Low Power VLSI Design etc.
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UiPath Test Automation using UiPath Test Suite series, part 4
Developing an Incident Response Process Model for Chemical Facilities
1. Best Practice of Incident
Response for Chemical Facilities
10th International ISCRAM Conference
Baden-Baden, Germany
Stephen C. Fortier
13 May 2013
2. Outline
• Statement of the Problem
• Significance
• Scope and Limitations
• Research Goals
• Research Methodology
• Qualitative Results
• Quantitative Results
• Summary of Findings
• Recommendations for Future Research
3. Statement of the Problem
• Chemical industry experts state that there is no
standard or defined incident response mechanisms
for the chemical industry. The experts said that
incident response ranged from ad hoc to very
formalized processes
• There is poor collaboration between process control
engineering and the information technology function
which leads to less effective incident response,
according to industry experts
• No comprehensive description of information
technology utilization for incident response
4. Significance
• A thorough review of the literature provided no
references to incident response mechanisms for the
chemical industry. This research examined the
current state-of-the-art of incident response
mechanisms for chemical facilities
• The development of a normalized incident response
model would contribute to the scientific body of
knowledge for incident response for chemical
facilities
5. Scope and Limitations
• This research was limited to incident response
mechanisms for chemical facilities, and does not
include preparedness or recovery
• The research is limited to the physical infrastructure
of a chemical facility, from the control of the chemical
processes to the perimeter of the site
• The timeline is limited from the first notification of an
unplanned release to the development of the “go
forward” plan
• This research does not include external actors such
a fire, rescue and police, etc.
6. Research Goals
• Define the essential elements of an effective and
efficient chemical facility incident response
mechanism
• Determine if the size of a chemical facility influences
its ability to provide an effective response to a threat
• Determine which technologies could be utilized to
improve the incident response mechanism
• Review the technology, processes and methods
used in incident response to provide a range of
improved solutions
7. Research Methodology
1. Interview industry experts. Developed an
understanding of the problem through the use of
informal interviews.
2. Formulate and test questions. Design of initial set
of questions that were vetted by industry experts
3. Set qualifications for chemical facility participation
(RMP*, CFATS, and Seveso)
4. Develop web-based questionnaire
5. Contact chemical facilities
8. Research Methodology (con’t)
6. Secure chemical facility participation. Collect and
analyze Emergency Response Plans from each of
the participating sites
7. Site visits and data collection. Administration of
questionnaire to statistically representative
population of mid- to senior-level chemical facility
workers (experts)
a) Create workflows for incident response
b) Identify “actors” during incident response
c) Identify information exchanged between activities
d) Determine tools and technology used during response
e) Determine timing and sequencing of activities during
incident response
9. Research Methodology (con’t)
8. Generation and aggregation of descriptive and
inferential statistical analysis of the questionnaire
results
9. Interpretation of qualitative and quantitative results
11. Study Group (con’t)
Workforce size of chemical facility
35 experts participated in the study
• Average years of experience: 22.09
• Median for years of experience: 20
• Standard deviation: 6.95
14. Use of Information Technology During
Incident Response
Utilization of information technology
for incident response
Use of automation during incident response
24. Summary of Findings (con’t)
• The size of a chemical facility does influence its
ability to respond to unplanned chemical releases
• The utilization of decision support tools would
improve incident response. The introduction of
repeatable business processes, collection and
reuse of incident data, and information technology
automation would significantly contribute to an
optimal incident response mechanism
25. Summary of Findings (con’t)
• Emergency response managers underestimate the
time required to fully understand the elements of an
unplanned release and develop a mitigation plan
• Decision support tools are not widely used during
incident response to assist in problem resolution
• Chemical facilities do not use an integrated
information technology solution to support incident
response
27. Further Research
• Develop an information model of the information
required during incident response. This model
would be integrated with related ontology efforts in
the emergency response community
• Expand and implement one or more of the incident
response process models at the chemical facilities
that participated in the research project
• Develop an integrated information system that ties
together all of the information elements that have an
impact on incident response
• Develop an evacuation model specific to the
chemical industry. Build on existing evacuation
models