WORKING WITH INDUSTRY – DESIGNING YOUR ACADEMIC RESEARCH FOR SUCCESSFUL COMME...catalyzing
This document discusses Good Laboratory Practices (GLP) for nonclinical laboratory studies. It covers the organization and requirements of GLP, including protocols, facilities, equipment, testing, records, reports, and quality assurance. Key points include conducting controlled studies using approved protocols, documenting methods and findings, and providing quality assurance reviews to ensure safety before human use. The quality assurance unit monitors studies for compliance and reports any issues to management. Proper documentation, facilities, equipment, and adherence to standard operating procedures are essential to meeting GLP principles.
Ohio Dept. of Health Guidelines for Analyzing Samples of Oil & Gas Wastes for...Marcellus Drilling News
Guidelines from the Ohio Dept. of Health that regulate how samples of oil and gas drilling wastes should be analyzed, part of the testing program to determine whether or not said wastes contain Technologically Enhanced Naturally Occurring Radioactive Material (TENORM). The new guidelines were stipulated under the 2013 House Bill 59.
Jeff Wright has over 20 years of experience as an analytical laboratory technician performing gas chromatography and high performance liquid chromatography analysis in a large-scale pharmaceutical GMP laboratory environment. He has worked at Pfizer in Kalamazoo, MI since 1984, serving as team lead for more than 10 years. Wright has extensive experience with instrument maintenance, calibration, sample testing, and reporting to support API production. He oversees process and equipment validation for new instruments and methods.
The document describes approaches for automatically detecting performance deviations in load testing of large scale systems. It presents four approaches: three unsupervised using clustering, random sampling, and PCA; and one supervised using WRAPPER. A case study evaluates the approaches on an open-source ecommerce system and industrial telecom system, finding the supervised WRAPPER and unsupervised PCA approaches most effective with high precision and recall. The WRAPPER approach allows real-time analysis but requires more manual overhead during training.
The document reports the findings of the third inter-laboratory analytical quality control exercise conducted by the Central Ground Water Board in Bhopal, India in June 2002. Thirty-eight water quality testing laboratories participated in the exercise. Laboratories were provided two synthetic water samples to analyze for nine parameters and their results were compared to reference values. Overall laboratory performance was mixed, with only one laboratory accurately analyzing all nine parameters. Conductivity, chloride, and total hardness saw the highest response rates, while boron saw the lowest. The report includes graphs comparing each laboratory's results to acceptable ranges and concludes some laboratories exhibited mostly random errors while others showed systematic errors. Recommendations are made to improve laboratory analytical capabilities.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
WORKING WITH INDUSTRY – DESIGNING YOUR ACADEMIC RESEARCH FOR SUCCESSFUL COMME...catalyzing
This document discusses Good Laboratory Practices (GLP) for nonclinical laboratory studies. It covers the organization and requirements of GLP, including protocols, facilities, equipment, testing, records, reports, and quality assurance. Key points include conducting controlled studies using approved protocols, documenting methods and findings, and providing quality assurance reviews to ensure safety before human use. The quality assurance unit monitors studies for compliance and reports any issues to management. Proper documentation, facilities, equipment, and adherence to standard operating procedures are essential to meeting GLP principles.
Ohio Dept. of Health Guidelines for Analyzing Samples of Oil & Gas Wastes for...Marcellus Drilling News
Guidelines from the Ohio Dept. of Health that regulate how samples of oil and gas drilling wastes should be analyzed, part of the testing program to determine whether or not said wastes contain Technologically Enhanced Naturally Occurring Radioactive Material (TENORM). The new guidelines were stipulated under the 2013 House Bill 59.
Jeff Wright has over 20 years of experience as an analytical laboratory technician performing gas chromatography and high performance liquid chromatography analysis in a large-scale pharmaceutical GMP laboratory environment. He has worked at Pfizer in Kalamazoo, MI since 1984, serving as team lead for more than 10 years. Wright has extensive experience with instrument maintenance, calibration, sample testing, and reporting to support API production. He oversees process and equipment validation for new instruments and methods.
The document describes approaches for automatically detecting performance deviations in load testing of large scale systems. It presents four approaches: three unsupervised using clustering, random sampling, and PCA; and one supervised using WRAPPER. A case study evaluates the approaches on an open-source ecommerce system and industrial telecom system, finding the supervised WRAPPER and unsupervised PCA approaches most effective with high precision and recall. The WRAPPER approach allows real-time analysis but requires more manual overhead during training.
The document reports the findings of the third inter-laboratory analytical quality control exercise conducted by the Central Ground Water Board in Bhopal, India in June 2002. Thirty-eight water quality testing laboratories participated in the exercise. Laboratories were provided two synthetic water samples to analyze for nine parameters and their results were compared to reference values. Overall laboratory performance was mixed, with only one laboratory accurately analyzing all nine parameters. Conductivity, chloride, and total hardness saw the highest response rates, while boron saw the lowest. The report includes graphs comparing each laboratory's results to acceptable ranges and concludes some laboratories exhibited mostly random errors while others showed systematic errors. Recommendations are made to improve laboratory analytical capabilities.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
On-stream inspections are non-destructive examinations performed on equipment while still in operation to evaluate mechanical integrity. They improve safety and reduce costs by minimizing internal inspections that require cleaning and vessel entry. On-stream inspections also improve mechanical integrity by allowing more frequent inspections to catch issues early without increasing corrosion or cracking risks from internal inspection activities. Risk-based inspection programs identify the appropriate non-destructive testing method and inspection frequency based on potential damage mechanisms and their risks.
This PPT gives the idea about importance of audit. Every QA personnel should aware about the fact behind every aspects of audit. This PPT is useful for all auditor in pharmaceutical domain.
This document provides the contact information, qualifications, and work experience of Rex Cress, who is seeking employment as a Level II NDT Inspector. He has 12 years of experience in naval aviation non-destructive testing and holds Level II certifications in multiple NDT methods. His experience includes roles in production control, quality assurance, and as a non-destructive testing technician performing inspections on various aircraft and equipment.
SCT an Advanced Pipeline Integrity SolutionBrett Payton
The SCT Technique fills the gap in the armory of integrity engineers when assessing the condition of difficult to inspect pipelines and is being referred to as a "game changer" by many individuals in the industry.
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
This document provides an overview of Spill Prevention, Control, and Countermeasure (SPCC) plans, which are special rules to prevent oil discharges into U.S. waters. It outlines key requirements and secrets of SPCC plans, such as what constitutes an oil, circumstances for self-certification, the powers of professional engineers, requirements for secondary containment and industry standards, and enforcement. The document emphasizes that SPCC plans must say what facilities do and facilities must do what the plans say to prevent oil spills.
Pipeline documentation is required to provide a history of pipelines and ensure regulatory compliance. Key documents that should be retained include pipeline maps, licensing information, inspection records, corrosion monitoring data, repair reports, and audit results. Proper documentation of tasks like right-of-way patrols, material balances, shutdown device testing, corrosion assessments, and repairs provides a history to evaluate pipeline integrity and ensure safety requirements are met. Documentation should generally be kept for the life of the pipeline.
The document advertises a hybrid training program on API 579 - Fitness for Service that will take place in Kuala Lumpur, Malaysia from May 9-13, 2016 and in Bandung, Indonesia from October 17-21, 2016. The 5-day course will provide an in-depth discussion of Fitness for Service concepts and assessments based on API 579 with a focus on degradation mechanisms, failure analysis, and remaining life assessment. It will include presentations, case studies, exercises and a certificate of attendance for those who attend at least 80% of the sessions. The course is aimed at engineers involved in integrity assessment and maintenance of pressure vessels, piping, tanks and other process equipment.
Gautham Dileep is a mechanical engineer with 3 years of experience in quality management and testing. He is seeking a position as a QA/QC engineer. He has skills in quality assurance, quality control, auditing, and inspection techniques. He has worked as a QA/QC engineer and trainee conducting inspections, developing quality plans, identifying non-compliance issues, and ensuring products meet standards. He has a Bachelor's degree in Mechanical Engineering and training in areas like lead auditing, phosphate inspection, and qualified connection licenses.
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
The document provides information and instructions for students attending orientation at UCF Valencia West or UCF Valencia Osceola. It outlines the orientation and advising process, how to access important resources like the undergraduate catalog and myUCF portal, and guides students through reviewing their degree audit and registering for classes.
The document recommends drinking 1.5 liters of water per day to cure various diseases. It claims that drinking this amount of water every morning on an empty stomach can cure conditions like constipation within 1 day, acidity within 2 days, diabetes within 7 days, and cancer within 4 weeks. The water purifies the body by forming new blood and activating the colon and intestines. It encourages sharing this message to help humanity.
This document summarizes key findings from several studies on the relationship between file sharing and music sales. The main points are:
1) Empirical research shows file sharing can either hurt or help music sales, with the majority of studies finding some negative effect, typically estimated around a 20% reduction in sales.
2) However, factors like concert revenue and complementary products like iPods have become major income sources, so the overall industry is in better financial shape when these are considered alongside recorded music sales.
3) One study found higher levels of pre-release file sharing did not significantly reduce album chart survival times, and may have even increased survival for more popular albums. The effect of sharing was found to be
The document discusses characterization in literature and describes five ways authors show characterization: 1) The writer tells the reader directly about the character, 2) The writer includes the actual words spoken by the character, 3) The writer reveals what a character is feeling or thinking, 4) The writer describes the character's actions, and 5) The writer describes how other people respond to or interact with the character.
Este story board propone una película de 10 minutos sobre la limpieza en una escuela durante 10 años. Presenta 13 tomas con su duración, tipo de imagen y audio correspondiente. Celebrará el aniversario de la limpieza en la escuela pero también resaltará el trabajo de las personas que la mantienen limpia a diario. Finalizará agradeciendo su labor por mantener la escuela en buenas condiciones.
This document discusses how facilities management organizations can generate income through digital strategies. It outlines that these organizations provide both services and products through facilities like pools, gyms, and event spaces. Historically, digital has been treated as a separate channel by marketing or operations departments. However, a unified digital strategy is needed that identifies the audience and services they seek across touchpoints. An effective strategy engages the audience, offers convenience and value, and streamlines processes through self-service options. This involves moving beyond segmented treatments of digital to have organization-wide focus on the audience experience through a cohesive brand message.
DrugInfo seminar: Stepping out of the SHADE. The use of ehealth approaches in...Australian Drug Foundation
This document summarizes research on the SHADE Project, which uses a computerized cognitive behavioral therapy (CBT) and motivational interviewing (MI) program to treat comorbid depression and alcohol/other drug use problems. It finds that comorbidity is associated with greater disease burden and difficulties accessing treatment. The SHADE Project developed and tested an e-health intervention that could potentially improve treatment accessibility and outcomes for comorbid conditions. Results showed the e-health program was as effective as face-to-face CBT in reducing depression, alcohol and cannabis use, with benefits for adherence and empowering self-management. However, wider adoption of e-health faces challenges around technology access, clinical acceptance, and understanding of potential benefits
On-stream inspections are non-destructive examinations performed on equipment while still in operation to evaluate mechanical integrity. They improve safety and reduce costs by minimizing internal inspections that require cleaning and vessel entry. On-stream inspections also improve mechanical integrity by allowing more frequent inspections to catch issues early without increasing corrosion or cracking risks from internal inspection activities. Risk-based inspection programs identify the appropriate non-destructive testing method and inspection frequency based on potential damage mechanisms and their risks.
This PPT gives the idea about importance of audit. Every QA personnel should aware about the fact behind every aspects of audit. This PPT is useful for all auditor in pharmaceutical domain.
This document provides the contact information, qualifications, and work experience of Rex Cress, who is seeking employment as a Level II NDT Inspector. He has 12 years of experience in naval aviation non-destructive testing and holds Level II certifications in multiple NDT methods. His experience includes roles in production control, quality assurance, and as a non-destructive testing technician performing inspections on various aircraft and equipment.
SCT an Advanced Pipeline Integrity SolutionBrett Payton
The SCT Technique fills the gap in the armory of integrity engineers when assessing the condition of difficult to inspect pipelines and is being referred to as a "game changer" by many individuals in the industry.
Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
This document provides an overview of Spill Prevention, Control, and Countermeasure (SPCC) plans, which are special rules to prevent oil discharges into U.S. waters. It outlines key requirements and secrets of SPCC plans, such as what constitutes an oil, circumstances for self-certification, the powers of professional engineers, requirements for secondary containment and industry standards, and enforcement. The document emphasizes that SPCC plans must say what facilities do and facilities must do what the plans say to prevent oil spills.
Pipeline documentation is required to provide a history of pipelines and ensure regulatory compliance. Key documents that should be retained include pipeline maps, licensing information, inspection records, corrosion monitoring data, repair reports, and audit results. Proper documentation of tasks like right-of-way patrols, material balances, shutdown device testing, corrosion assessments, and repairs provides a history to evaluate pipeline integrity and ensure safety requirements are met. Documentation should generally be kept for the life of the pipeline.
The document advertises a hybrid training program on API 579 - Fitness for Service that will take place in Kuala Lumpur, Malaysia from May 9-13, 2016 and in Bandung, Indonesia from October 17-21, 2016. The 5-day course will provide an in-depth discussion of Fitness for Service concepts and assessments based on API 579 with a focus on degradation mechanisms, failure analysis, and remaining life assessment. It will include presentations, case studies, exercises and a certificate of attendance for those who attend at least 80% of the sessions. The course is aimed at engineers involved in integrity assessment and maintenance of pressure vessels, piping, tanks and other process equipment.
Gautham Dileep is a mechanical engineer with 3 years of experience in quality management and testing. He is seeking a position as a QA/QC engineer. He has skills in quality assurance, quality control, auditing, and inspection techniques. He has worked as a QA/QC engineer and trainee conducting inspections, developing quality plans, identifying non-compliance issues, and ensuring products meet standards. He has a Bachelor's degree in Mechanical Engineering and training in areas like lead auditing, phosphate inspection, and qualified connection licenses.
This document summarizes a discussion forum on ICH Q7 & Q11 regarding DMFs, impurities, CTD, and challenges. It provides an outline of drug master files, types of DMFs, classes of impurities in APIs, elements of a control strategy, sections of the common technical document that contain established conditions, and challenges faced. The presentation focused on established conditions, control strategies, their relationship, and how established conditions are presented in CTD sections.
The document provides information and instructions for students attending orientation at UCF Valencia West or UCF Valencia Osceola. It outlines the orientation and advising process, how to access important resources like the undergraduate catalog and myUCF portal, and guides students through reviewing their degree audit and registering for classes.
The document recommends drinking 1.5 liters of water per day to cure various diseases. It claims that drinking this amount of water every morning on an empty stomach can cure conditions like constipation within 1 day, acidity within 2 days, diabetes within 7 days, and cancer within 4 weeks. The water purifies the body by forming new blood and activating the colon and intestines. It encourages sharing this message to help humanity.
This document summarizes key findings from several studies on the relationship between file sharing and music sales. The main points are:
1) Empirical research shows file sharing can either hurt or help music sales, with the majority of studies finding some negative effect, typically estimated around a 20% reduction in sales.
2) However, factors like concert revenue and complementary products like iPods have become major income sources, so the overall industry is in better financial shape when these are considered alongside recorded music sales.
3) One study found higher levels of pre-release file sharing did not significantly reduce album chart survival times, and may have even increased survival for more popular albums. The effect of sharing was found to be
The document discusses characterization in literature and describes five ways authors show characterization: 1) The writer tells the reader directly about the character, 2) The writer includes the actual words spoken by the character, 3) The writer reveals what a character is feeling or thinking, 4) The writer describes the character's actions, and 5) The writer describes how other people respond to or interact with the character.
Este story board propone una película de 10 minutos sobre la limpieza en una escuela durante 10 años. Presenta 13 tomas con su duración, tipo de imagen y audio correspondiente. Celebrará el aniversario de la limpieza en la escuela pero también resaltará el trabajo de las personas que la mantienen limpia a diario. Finalizará agradeciendo su labor por mantener la escuela en buenas condiciones.
This document discusses how facilities management organizations can generate income through digital strategies. It outlines that these organizations provide both services and products through facilities like pools, gyms, and event spaces. Historically, digital has been treated as a separate channel by marketing or operations departments. However, a unified digital strategy is needed that identifies the audience and services they seek across touchpoints. An effective strategy engages the audience, offers convenience and value, and streamlines processes through self-service options. This involves moving beyond segmented treatments of digital to have organization-wide focus on the audience experience through a cohesive brand message.
DrugInfo seminar: Stepping out of the SHADE. The use of ehealth approaches in...Australian Drug Foundation
This document summarizes research on the SHADE Project, which uses a computerized cognitive behavioral therapy (CBT) and motivational interviewing (MI) program to treat comorbid depression and alcohol/other drug use problems. It finds that comorbidity is associated with greater disease burden and difficulties accessing treatment. The SHADE Project developed and tested an e-health intervention that could potentially improve treatment accessibility and outcomes for comorbid conditions. Results showed the e-health program was as effective as face-to-face CBT in reducing depression, alcohol and cannabis use, with benefits for adherence and empowering self-management. However, wider adoption of e-health faces challenges around technology access, clinical acceptance, and understanding of potential benefits
Ohio Dept. of Health Guidelines for Sampling Oil & Gas Wastes for TENORMMarcellus Drilling News
Guidelines from the Ohio Dept. of Health that regulate how samples of oil and gas drilling wastes should be handled during the sampling process, part of the testing program to determine whether or not said wastes contain Technologically Enhanced Naturally Occurring Radioactive Material (TENORM). The new guidelines were stipulated under the 2013 House Bill 59.
This document provides an overview of a pilot demonstration test for the PCAPP facility. The test has 11 main objectives, including demonstrating agent removal, treatment and neutralization, energetics removal, and integrated facility operations. It will validate monitoring, waste handling, and off-gas treatment protocols. The facility consists of 6 processing blocks that work sequentially: munitions preparation (Block 1), body treatment (Block 2), agent collection and neutralization (Block 3), hydrolysate treatment (Block 4), decontamination (Block 5), and off-gas treatment (Block 6). The test will process 155mm munitions first before changing over to 105mm and 4.2in munitions. Emissions sampling will be conducted to support
The document outlines the learning outcomes, assessment criteria, and learning content for units of competency related to operating a road roller. It includes modules on performing pre- and post-operation procedures, preventative maintenance, and road roller operation. The modules cover identifying road roller components, performing safety and operational checks, basic maintenance tasks, loading and unloading procedures, traveling with the road roller, and compaction techniques. Safety practices and following manufacturer and company procedures are emphasized throughout.
This document provides guidelines for quantifying and reporting the carbon footprint of a product (CFP) in accordance with international life cycle assessment standards (ISO 14040 and 14044). It specifies that a CFP study should include defining the goal and scope, performing a life cycle inventory analysis, conducting a life cycle impact assessment for climate change, and interpreting the results. The document establishes requirements for determining the system boundary, data quality, and addressing the use and end-of-life stages of a product. Adopting existing product category rules is recommended where relevant.
The document discusses hazard identification techniques used in process facilities, including:
- Preliminary Hazard Analysis which identifies hazards from raw materials, equipment, facilities, and other factors in early design stages.
- HAZOP (Hazard and Operability Study) which is a systematic technique applied to small parts of a design to identify deviations from design intent, their causes and consequences, and recommendations.
- Guidelines for applying techniques like HAZOP include considering parameters like flow, pressure, temperature, and using guidewords to identify potential deviations from design intent.
This document outlines the specific requirements of a Validation Master Plan (VMP) for a pharmaceutical company. It discusses 11 key sections that should be included in a VMP: 1) approval page and table of contents, 2) introduction and objectives, 3) plant and process description, 4) personnel, planning and scheduling, 5) responsibilities of committee members, 6) process control aspects, 7) equipment and apparatus to be qualified, 8) processes and systems to be validated, 9) acceptance criteria, 10) documentation, and 11) SOPs. The VMP provides a complete scope and timeline for validating all facilities, equipment, materials, and processes to ensure regulatory compliance.
The document is a Test & Evaluation Master Plan (TEMP) for the Expeditionary Fighting Vehicle (EFV) that outlines the integrated test program and resources needed to test and evaluate the EFV system. Key points include:
- The EFV is an amphibious assault vehicle being developed for the US Marine Corps to deploy troops from ships to shore under hostile conditions.
- The test program includes developmental testing to verify requirements are met and operational testing to validate performance. Multiple live fire, terrain, and maritime tests are planned over several years.
- Resources needed for testing include prototype vehicles, test sites with various terrain types, live fire ranges, Navy assets, and trained Marine Corps personnel. Facilities from H
Syed K. Rizvi is a chemical engineer with over 30 years of experience in petroleum testing, laboratory management, process engineering, and project management. He currently works as a Lab Technical Team Lead/Manager at Suncor Energy, where he is responsible for new technology introductions, equipment reliability, and methodology development. Previously he has held roles such as Lab Manager, Scientific Specialist, and Quality Assurance Manager. He has a strong technical background and proven skills in developing testing methods, authoring standard operating procedures, and training technicians.
The document defines maintenance and discusses types of maintenance programs. It outlines key elements of a maintainability program plan including interfaces between maintainability and other project organizations. Various maintenance system procedures are described for equipment like boilers, turbines, generators and switchgear. Maintainability analysis tools including FFBDs, timelines, FMECAs, and models are also summarized. The conclusion states that early maintainability planning can lower risks and costs.
The document discusses Metal and Recycling Company's (MRC) implementation of an ISO 14001 environmental management system (EMS) and certification process. It provides an overview of MRC's operations and environmental commitments. It then details the 18 elements of MRC's EMS which address planning, implementation, checking, and management review in line with ISO 14001 requirements. Finally, it outlines 19 action items and responsibilities to improve specific environmental aspects of MRC's operations.
This document provides guidance for certification body auditors on conducting audits according to ISO/TS 16949. It outlines 31 required audit activities in a process flow chart and table. The table defines the knowledge and skills required of auditors for each activity, referencing source documents. It aims to ensure auditors are competent in areas that have been identified through IATF oversight of audits, such as having a process approach and knowledge of customer requirements and ISO/TS 16949.
This document summarizes key EPA guidance documents for environmental quality assurance programs. It discusses the purpose of quality assurance programs to ensure data is scientifically sound and legally defensible. A quality system provides a framework for planning, implementation, and assessment of work. It also describes the data quality objectives process which is a systematic planning tool to ensure data meets the needs of its intended use. EPA SW-846 provides standardized test methods for evaluating waste characteristics under the Resource Conservation and Recovery Act.
Entrion provides vendor surveillance and inspection services globally to ensure on-time delivery of quality equipment. They have over 100 experienced professionals located near major manufacturers who perform risk-based inspections during key stages such as design, fabrication, testing, and installation. This helps identify issues early to prevent delays and ensure operational readiness. Entrion has successfully supported many projects in industries like offshore drilling, refining, and shipping. Their standardized processes and global network allow them to provide a cost-effective 59% savings over alternative inspection options.
ICH AND WHO GUIDELINES FOR VALIDATION OF EQUIPMENTS.pptxABG
The document discusses guidelines from the International Conference on Harmonization (ICH) and the World Health Organization (WHO) for validating equipment used in the pharmaceutical industry. It provides an overview of the key stages of validation: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). DQ defines the functional specifications for equipment. IQ establishes that equipment is properly installed. OQ demonstrates equipment will function as specified. PQ shows equipment consistently meets performance standards for routine use. The document provides details on documentation requirements and test procedures for each qualification stage according to ICH and WHO guidelines.
HAZOP ANALYSIS
A Hazard and Operability (HAZOP) study is a systematic technique used to identify potential problems in processes. It involves examining a system and considering how intended design can deviate. A multidisciplinary team applies guidewords to parameters at nodes to identify causes and consequences of deviations. The team then recommends safeguards. HAZOP is useful early in design and can be applied to processes, procedures, software and human factors. It provides a structured way to brainstorm hazards without requiring quantification of risks.
The document discusses the qualification of HVAC systems used in pharmaceutical manufacturing. It covers the objectives of qualifying HVAC systems, the documentation requirements, commissioning process, qualification process including design qualification, installation qualification, operational qualification and performance qualification, parameters to test during qualification, ongoing monitoring and maintenance. The qualification ensures the HVAC system meets design specifications and supports GMP compliance. Risk assessments should be conducted to determine critical parameters and qualification approach.
The document is a certified test report from the University of Miami evaluating the tensile properties of basalt composite rebar for concrete reinforcement according to ASTM D7205. It summarizes that the testing was performed to support material certification for use of the basalt rebar as internal reinforcement of concrete structures. The test results showed that the tensile properties of the basalt rebar met the requirements for such use according to criteria set by the International Code Council Evaluation Service.
Accompanying notes for ep seminar presentation version 2 morgan mar 2013Andrew Morgan
The document discusses the regulatory requirements for environmental plans (EPs) related to coastal and offshore resource development projects in Australia. It notes that EPs must demonstrate that environmental impacts and risks will be reduced to as low as reasonably practicable and at an acceptable level. They must also include appropriate objectives, standards and criteria for measuring performance. The document emphasizes that EPs require a well-structured approach to demonstrate compliance with all regulatory criteria and ensure impacts are properly assessed, managed and mitigated.
The Kentucky Chemical Demilitarization Citizens Advisory Commission and Chemical Destruction Citizens Advisory Board wrote to the commander of the Blue Grass Chemical Activity to acknowledge efforts to provide information about mold mitigation at the site and to provide observations and recommendations. The advisory boards noted contradictions between current empirical evidence of mold in some igloos and previous studies. They recommended keeping vents open on all igloos except three with mold growth and continuing mitigation efforts in those three igloos, as well as any increased inspections needed due to closed vents.
The Pentagon has directed ACWA to develop an alternative approach for hydrolysate treatment at Pueblo and Blue Grass in case the on-site methods become incapable. ACWA wants to develop criteria with input from the CACs and NRC for evaluating any alternative treatment approaches. ACWA will have the CACs review a statement of task for the NRC before submitting. The NRC is expected to deliver a letter report for Pueblo in 10-12 months and a full report for Blue Grass in 18 months. Developing contingency criteria does not imply changes to current on-site hydrolysate treatment and allows for community input. The SWWG should review the statement of task and engage in developing the criteria.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and
Chemical Destruction Community Advisory Board
Presented by:
Jeff Brubaker Doug Omichinski
Site Project Manager Project Manager
The document provides updates from various working groups of the Chemical Destruction Citizens Advisory Board (CDCAB). The Economic Development Working Group is conducting a three-phase economic impact study of the chemical destruction process. The Secondary Waste Working Group is focusing on a planned rocket separation operation and submitted comments on its required permits. The Monitoring Working Group developed and circulated a recommendation regarding mold mitigation efforts at the Blue Grass Chemical Activity, advising that vents remain open on most igloos containing chemical agents.
LTC Christopher Grice provided an update on the rocket separation operation at Blue Grass Chemical Activity to the Kentucky Chemical Demilitarization Citizens’ Advisory Commission and Kentucky Chemical Destruction Community Advisory Board. The rocket separation was completed on May 13, 2014, with 42 of 44 planned rockets separated. Samples from each of the 19 unique propellant lots were taken, with 23 samples shipped to ARDEC for testing in June and the remaining 19 stored for future testing by BGCAPP. All rocket motor samples were monitored and found to be free of chemical agents according to DA PAM 385-61.
The document provides a quarterly update on the Blue Grass Chemical Agent-Destruction Pilot Plant project. Construction is over 82% complete and systemization activities are over 18% complete. Upcoming work includes starting construction of the Container Handling Building, Medical Facility, and Personnel Maintenance Building. Laboratory testing of dilute mustard agent will begin this summer. Safety performance remains high, with recordable and lost-time injury rates well below industry averages. Community involvement efforts have raised over $100,000 for local charities.
The document provides an update from the Economic Development Working Group co-chair Craig Williams. It summarizes work analyzing the existing workforce and economic environment in Madison and Rockcastle counties in Kentucky, known as the Richmond-Berea micropolitan statistical area. The analysis includes educational attainment levels and age structure of the population based on US Census data to understand how to potentially mitigate effects of anticipated economic events. Future meetings and a final report are planned.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission and Kentucky Chemical Destruction Community Advisory Board
Presented by:
LTC Christopher Grice
Commander, Blue Grass Chemical Activity
The document discusses ACWA funding for fiscal year 2015. It states that ACWA is fully funded for 2015 with $575.9 million allocated for research, development, testing and evaluation split between ACWA sites and $38.7 million allocated for military construction for the BGCAPP program, bringing BGCAPP's funding level to approximately $326.65 million. The document was presented by Craig Williams on June 11, 2014 and includes a section for questions and discussion.
The document summarizes plans to implement an explosive destruction technology (EDT) to destroy over 15,000 mustard projectiles at the Blue Grass Chemical Agent-Destruction Pilot Plant (BGCAPP). BGCAPP awarded a contract to UXB International in November 2013 to provide a static detonation chamber (SDC) for this purpose. Regulatory permitting processes are underway, including a RCRA Part B permit modification and Title V air permit revision. Key engineering documents like process flow diagrams, piping and instrumentation diagrams, and mass and energy balances will be included to support permit applications. Operations are scheduled to begin in winter 2016/early 2017 once the SDC system has been designed, constructed, tested, and permitted.
The document discusses plans to implement explosive destruction technology (EDT) to destroy over 15,000 mustard projectiles at the Blue Grass Chemical Agent-Destruction Pilot Plant (BGCAPP) in Kentucky. Bechtel Parsons Blue Grass (BPBG) awarded a contract to UXB International to use a static detonation chamber (SDC) system. The SDC design is underway and regulatory permitting processes have begun. Construction of the SDC facility is scheduled from fall 2014 to fall 2016 with operations starting in winter 2016/early 2017. Public meetings will provide information and get input on the EDT plans and permits.
The document summarizes the history and work of the Explosive Destruction Technology Working Group, which consists of members from various government and private organizations involved in the chemical weapons disposal process. It describes several key meetings where the group discussed using explosive destruction technology (EDT) to dispose of mustard munitions at Blue Grass Army Depot that were difficult to process through incineration. While the group did not endorse a specific EDT, they provided recommendations to consider EDTs if regulatory requirements and public involvement were met.
The document provides an update from the Explosive Destruction Technology (EDT) Working Group meeting on June 11, 2014. It includes information about a tour of the Anniston, Alabama EDT facility by working group members and details presented at the 30% design meeting, such as the EDT process equipment layout and schedule. It also notes differences between the Anniston and Blue Grass Army Depot EDT units and discusses the permit modification process.
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission/ Chemical Destruction Community Advisory Board Meeting
Presented by:
Jeff Brubaker
Site Project Manager
Presented to:
Kentucky Chemical Demilitarization Citizens’ Advisory Commission/ Chemical Destruction Community Advisory Board Meeting
Presented by:
Jeff Brubaker Tom McKinney
Site Project Manager Project Manager
The Economic Development Working Group met on September 11th to discuss action items from a previous meeting. They planned to expand distribution of an economic study and schedule a meeting to refine proposals for further phases of the study to seek funding. A separate Depot Development Coalition met on November 18th to discuss the economic study and pursue public-private partnership opportunities at the Blue Grass Army Depot. They assigned subcommittees to pursue further study funding and research partnership opportunities. The Working Group then met to distribute documents from the Office of Economic Adjustment and draft an application for funding to develop further phases of the economic study.
The document summarizes updates on several countries' progress toward destroying their chemical weapon stockpiles in accordance with the Chemical Weapons Convention. The United States, Russia, and Libya were unable to meet the 2012 deadline and submitted new plans to complete destruction by 2023, a classified date for Russia, and 2016 for Libya. The document also provides details on chemical weapons destruction facilities planned and operated by the United States and Libya.
The document summarizes Syria's chemical weapons disarmament schedule and process as agreed upon when Syria joined the Chemical Weapons Convention in September 2013, following allegations of chemical weapons attacks. Key points include: Syria's schedule for removing and destroying chemical weapons by mid-2014; plans to neutralize mustard agents and precursors aboard the MV Cape Ray using a field deployable hydrolysis system, as was successfully used in the US; outstanding issues regarding transport through Syria's conflict and risks of on-board work; and Kentucky's potential contributions based on its experience with chemical weapons destruction projects.
The document provides updates from four working groups of the Chemical Destruction Citizens Advisory Board:
1. The Economic Development Working Group met with state agencies to integrate support for a job loss study and brief congressional delegations.
2. The Secondary Waste Working Group discussed a proposed rocket separation operation and will make a recommendation to the full board.
3. The EDT Working Group notes Colorado's environmental assessment is complete and Kentucky's draft will be released after comments.
4. The Monitoring Working Group expects a decision soon on storage modifications based on previous recommendations.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
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A Guide to AI for Smarter Nonprofits - Dr. Cori Faklaris, UNC CharlotteCori Faklaris
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Food safety, prepare for the unexpected - So what can be done in order to be ready to address food safety, food Consumers, food producers and manufacturers, food transporters, food businesses, food retailers can ...
AHMR is an interdisciplinary peer-reviewed online journal created to encourage and facilitate the study of all aspects (socio-economic, political, legislative and developmental) of Human Mobility in Africa. Through the publication of original research, policy discussions and evidence research papers AHMR provides a comprehensive forum devoted exclusively to the analysis of contemporaneous trends, migration patterns and some of the most important migration-related issues.
United Nations World Oceans Day 2024; June 8th " Awaken new dephts".Christina Parmionova
The program will expand our perspectives and appreciation for our blue planet, build new foundations for our relationship to the ocean, and ignite a wave of action toward necessary change.
Jennifer Schaus and Associates hosts a complimentary webinar series on The FAR in 2024. Join the webinars on Wednesdays and Fridays at noon, eastern.
Recordings are on YouTube and the company website.
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4. Briefing Objective
Provide an overview of the PCAPP Operational
Readiness Review (ORR) process and the
incremental approach to be used to assess
readiness for Initial Agent Operations (IAO)
4
5. Operational Readiness Review Overview
The ORR process is used to
validate that PCAPP “plant, paper,
and people” collectively meet the
required criteria to allow a new
operation to begin.
PCAPP ORR process is led by the
system-contractor (SC) to
support a declaration of
readiness.
ACWA provides ORR oversight;
independent validation is used to
support the SC’s declaration of
readiness.
Stakeholders may observe the
ORR process.
5
People
PlantPaper
Achieve Readiness – by Responsible Managers
Validate Readiness – by ORR Board
Declare Readiness – by Project Manager
Accept Readiness – by ACWA
6. ORR Overview
6
People Readiness
Paper Readiness
Plant Readiness
Ready for Agent Operations
Government Review and Concurrence
SPM ACWA concurrence
with BNI ORR
BPT declares readiness
for agent operations
The ORR process validates that
PCAPP plant, paper, and people
collectively meet the required
criteria to allow agent-
operations to begin.
System Start-up, Testing, and
Turnover to Operations
System Start-up, Testing, and
Turnover to Operations
Approve Permits,
Plans, Procedures,
Classes
Certify, Drill,
Optimize
IOD
Integrated Operations
Demonstration (IOD)
Readiness
The goal of Systemization is to achieve readiness for
Initial Agent Operations.
7. Stages of an ORR
Planning:
Define Scope of ORR in an Implementing Procedure using Performance
Objectives and Criteria (PO&Cs)
Identify Responsible Managers and pool of Independent Reviewers
Charter the ORR Board
Execution:
Responsible Managers define how readiness is achieved using affidavits
Independent reviewers conduct interviews, review documents, and
observe field work to assess the degree of compliance with readiness
requirements
ORR Board reviews documentation to assess readiness
“Punchlist items” are defined as findings and tracked to closure
Usually ends after an Integrated Operations Demonstration (IOD) to
exercise and assess plant, paper, and people functioning together
7
8. ORR Planning
PO&Cs are requirements for readiness, defined in cascading levels of detail
Derived from contract defined requirements, such as:
• Safety/environmental regulations (e.g., OSHA, RCRA, CAA)
• Army regulations and guidance (e.g., AR 50-6, DA PAM 385-61)
• Industry standards (e.g., ANSI, NFPA)
Developed by responsible managers and the ORR Team
Reviewed by ACWA and stakeholders
Approved by issuance of an ORR implementing procedure
8
Criterion 1.1
Criterion 1.2
Criterion 1.3
Criterion 1.4
Criterion 1.5
Criterion 1.6
Criterion 2.1
Criterion 2.2
Criterion 2.3
Criterion 2.4
Functional Area (by Responsible Manager)
Performance
Objective 1.0
Performance
Objective 2.0
Develop Performance Objectives and Criteria (PO&Cs)
Level 3 Criterion
A specific statement describing an element of readiness
within a performance objective (e.g., “A process is in
place to notify key treaty personnel when applying or
removing treaty seals, to track treaty sealing information,
and protocols are established for treaty seal application
and removal. Treaty seals have been applied to the
agreed upon doors/areas/equipment.“)
Level 2 Performance Objectives (POs)
A statement describing an aspect or area of readiness
within a functional area (e.g., “Treaty requirements are in
place for initial agent operations.“)
Level 1 Functional Areas
Typically follow organizational lines (e.g., Safety, Lab)
9. ORR Overview – Process
9
Board accepts
affidavit?
NO
Responsible manager
completes affidavit
Board reviews CRAD
Finding Categories
Assigned by Board
Responsible manager
completes actions
required to correct
deficiency
Finding closed?
NO
YES
IR evaluates criteria
and affidavit
Board chartered
Functional areas defined
Board reviews
affidavit
Requirements defined
Independent reviewers
(IRs) selected
IR completes CRAD
Affidavit and CRAD
packages finalized,
archived for report
Board accepts
CRAD?
YES
NO
YES
Criterion met?
Finding(s) generated or
approved to address
identified deficiencies
NO
Readiness Planning Stage
Board reviews
corrective actions and
finding closure
document
All criteria
met, all
CAT1
findings
closed, final
report
completed
DeclarationofReadiness
Finding closure approved
by the Board, archived
for report
YES
LORR Execution Stage (Single Criterion)
Finding categories
assigned by ORR Board
Performance objectives &
criteria developed
11. Initial Agent Operations
(IAO) Criteria
11
by Functional Area
Number of criteria subject to change through
implementing procedure review process
12. Integrated Operations
Demonstrations (IOD)
Near the end of ORR, integrated operations demonstrations (IODs)
are performed to validate that people, plant, and paper are ready for
initial agent operations.
IODs include exercises such as:
Receive, transfer, and process munitions
Handle, transfer, and process simulated agent-contaminated waste
Perform toxic area entries; perform maintenance for critical equipment
Sample tanks/perform laboratory analysis
Perform treaty sampling
Respond to contingencies or equipment upset conditions
Upon successful completion of IODs and closeout of
required Findings, SC will declare readiness.
Upon receipt of an endorsement of readiness
by ACWA, PCAPP will be poised to begin Pilot Testing.
12
16. PCAPP Pilot Test Demonstration
Objectives1
1. Demonstrate agent removal, agent neutralization, and related agent
neutralization sampling and analysis.
2. Demonstrate munition body treatment (washout, thermal treatment).
3. Establish bounding operating ranges and set points for operating
parameters critical to agent removal, munition body treatment, and agent
neutralization operations.
4. Demonstrate energetics removal and establish bounding operating ranges
and set points for operating parameters critical to ensuring energetics
removal operations.
5. Validate monitoring protocols for all equipment and work areas in the ERB
and APB.
6. Validate treatment and monitoring protocols for disposition of dunnage,
energetics, and miscellaneous waste (e.g., OPP, PME, SDU, Autoclave as
designated for each waste material)
7. Demonstrate removal of TDG and document removal of other organic
compounds from hydrolysate waste stream (e.g., ICB, BRS)
8. Demonstrate processing systems can operate at a ramp rate that safely
supports the operating schedule.
1DERIVED FROM THE TEST CONCEPT PLAN, APPENDIX D; 3/21/2011
16
17. PCAPP Pilot Test Demonstration
Objectives (CONT.)
9. Demonstrate integrated facility operations with agent and energetics to verify
the following:
a) Compliance with safety requirements
b) Compliance with surety and security requirements
c) Integrated system operability
d) Plant-wide operations while remaining within emissions requirements (as stated in the Multiple
Pathway Health Risk Assessment Report for PCAPP Project [MPHRA], 24852-RD-3RC-000-V0004)
e) Handling and movement of munitions for current munitions campaign
f) Sampling and analysis protocols (e.g., agent, hydrolysate, brine, emissions)
g) Decontamination operations
h) Ability to perform routine and selected off-normal maintenance activities
i) Waste handling and disposition, including dust and odor control
10.Validate agent monitoring protocols for detecting agent (e.g., MINICAMS, Depot
Area Air Monitoring System [DAAMS]).
11.Demonstrate off-gas treatment performance. This will include demonstration of
agent destruction and removal at the OTS and AFA, odor control at the BTA.
17
Finally, the collection of site-wide emissions data for
finalization of the RCRA Part B Permit
18. Block 1 –
Systems, Fit, and Function
18
Systems: Block 1 – Baseline and Enhanced Reconfiguration includes OPP Monitoring, Munitions Monitoring
Table (Baseline Reconfiguration), PMD Operations and MME/PME Operations
Fit: After transport and receipt of munitions at PCAPP and prior to agent removal activities
Function: Prepares munitions for access and removal of agent by separating packing material (e.g., wooden
pallets, strapping, boxes) and energetics/miscellaneous parts from the munitions bodies
Explosion Containment
Room
19. MWS
MTU
Block 2 –
Systems, Fit, and Function
Systems: Block 2 – Munitions Body Treatment includes Munitions Washout System (MWS) and Munitions
Treatment Unit (MTU)
Fit: After Baseline and Enhanced Reconfiguration and prior to Agent Collection and Neutralization
Function: Drains and washes agent from energetics-free munitions bodies and thermally treats munitions
bodies to Clean Unrestricted, Releasable to the General Population (Clean Unrestricted)
19
20. Block 3 –
Systems, Fit, and Function
20
Systems: Block 3 – Agent Collection and Neutralization includes the Agent Water Separators, Wash Water Holding
Tanks, Agent Hydrolyzers, Hydrolysate Hold Tanks and 30-Day Storage Tanks
Fit: After Agent Collection and prior to Bio-Treatment of the cleared hydrolysate
Function: Separates the MWS agent drained and rinse water, hydrolyzes the mustard agent, and verifies destruction
prior to treatment in the Immobilized Cell Bio Reactors
21. Block 4 –
Systems, Fit, and Function
21
Systems: Block 4 – Hydrolysate Treatment and Water Recovery includes the Bio-Treatment System, Water Recovery
System (Brine Concentrate Feed Tanks), and the Brine Reduction System plus associated off-gas treatment units
Fit: After agent neutralization and clearing in Block 3 and prior to process water recycle or to off-site shipment of
secondary wastes (salt cake / bio sludge)
Function: Removes thiodiglycol (TDG) and other organics through biodegradation, recovers process water, de-
waters sludge for disposal and treats off-gasses for discharge.
22. Block 5 –
Systems, Fit, and Function
Systems: Block 5 – Supplemental Decon Units and Autoclave
Fit: Receives materials, equipment, components, and waste materials from other process areas including ERB, APB,
ESM, MSM.
Function: Reduces agent contamination levels to acceptable levels for either reuse and/or off-site disposal
22
23. Block 6 –
Systems, Fit, and Function
23
Systems: Block 6 – Off-gas treatment system including thermal oxidizer and scrubbers, the agent filtration area
(including particulate & HEPA filtration, granulated activated carbon and sulfur impregnated carbon) and the AFA stack
Fit: Receives process off-gas from the OTS and HVAC exhaust from ERB and APB ventilation systems
Function: Treat process off-gasses and HVAC exhaust from engineering controlled spaces to remove agent and other
COC’s to prescribed levels before releasing to the atmosphere.
24. Process Layout by Blocks
PCAPP PROCESS DIAGRAM
24
EDT REMOVED FROM PCAPP SCOPE
CONTAMINATED ENERGETICS AND IN-PROCESS LEAKERS &
REJECTS SENT TO G-BLOCK FOR SUBSEQUENT PROCESSING
IN A GOVERNMENT SYSTEM
25. Test Sequence
Pilot Testing (155mm)
Block 1
Block 2
Block 3
Block 4
Block 5
Block 6
Changeover Testing
105mm Campaign
4.2in Campaign
• Testing ≡ to define optimized
operating parameters
• Ramp-up ≡ capability of
personnel and equipment to
sustain operations
• Demonstration ≡ capability
of each process system
within the facility to process
munitions for 4-hour periods
per shift
Block 1 – Munitions Receipt and Enhanced Reconfiguration is to
support the testing, ramp-up and demonstration of the other
systems within Blocks 2, 3, 4 and 6.
Block 5 – Secondary Waste Treatment
Operating
Permit
INTEGRATED FACILITY DEMONSTRATION TEST
• Emissions Sampling
25