The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.
This document provides an overview of quality assurance. It defines quality assurance as the process of checking that a product or service meets customer requirements. Key points covered include the difference between quality assurance and quality control, the development of quality assurance concepts, factors affecting product quality, and components of a quality assurance system such as standard operating procedures, training, and quality manuals. The document also discusses quality assurance cycles, quality by design, quality risk management, and the functions of quality assurance professionals.
The document defines a Pharmaceutical Quality System (PQS) and describes the PQS implemented at the Ninewells Aseptic Dispensing Unit. A PQS is the organized system that ensures medicinal products are of the required quality. The Ninewells unit prepares 38,000 items annually using isolators and laminar flow cabinets in grade B and C rooms. Key elements of its PQS include documentation control, standard operating procedures, change control, deviation management, personnel training, internal auditing, complaints handling, and quality reviews. However, a formal validation master plan is not currently in place.
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...PostgradoMLCC
The document provides guidance for test facility management on conducting internal reviews or audits of their quality assurance programs annually to ensure compliance with Good Laboratory Practice principles. It recommends verifying aspects of the quality assurance program such as having sufficient qualified personnel, conducting inspections according to plans, addressing deviations, and complying with policies and procedures. The reviews should be done by independent staff to avoid conflicts of interest, though the regulatory agency will take a pragmatic view for small facilities.
Aligning & implementation of ISO15189:2012 requirements in clinical laboratory includes enlisting & mapping the exact activities to be performed with each clause, having done the same it acts as a road map for monitoring & continuous improvement
This document discusses quality control and quality assurance in microbiological laboratory investigations. It emphasizes the importance of standard operating procedures, internal quality assessment, and external quality assessment. Quality control occurs at multiple stages of analysis, including pre-analytical (specimen collection and transport), analytical (reagents, equipment, procedures), and post-analytical (reporting and interpretation of results). A quality control officer oversees quality control in the department through regular monitoring, assessment, communication, and analysis of quality control data.
Role of hospital management related to patient safety in hospitals and the active roles played by them to improve patient safety. Details of actionable on part of hospital management pertaining to safety in hospitals.
The document describes an industry program in pharmaceutical quality assurance and quality control offered through distance learning. The 12-month program aims to enhance knowledge of quality professionals and provide in-depth training in areas like GMP, quality assurance, regulation, and statistics. It covers 7 modules and career prospects in quality assurance, control, auditing, and management are discussed. The program awards a certificate upon completion.
This document provides an overview of quality assurance. It defines quality assurance as the process of checking that a product or service meets customer requirements. Key points covered include the difference between quality assurance and quality control, the development of quality assurance concepts, factors affecting product quality, and components of a quality assurance system such as standard operating procedures, training, and quality manuals. The document also discusses quality assurance cycles, quality by design, quality risk management, and the functions of quality assurance professionals.
The document defines a Pharmaceutical Quality System (PQS) and describes the PQS implemented at the Ninewells Aseptic Dispensing Unit. A PQS is the organized system that ensures medicinal products are of the required quality. The Ninewells unit prepares 38,000 items annually using isolators and laminar flow cabinets in grade B and C rooms. Key elements of its PQS include documentation control, standard operating procedures, change control, deviation management, personnel training, internal auditing, complaints handling, and quality reviews. However, a formal validation master plan is not currently in place.
GOOD LABORATORY PRACTICE - GLPMA EXPECTATIOS FOR AUDIT OF THE QUALITY ASSURAN...PostgradoMLCC
The document provides guidance for test facility management on conducting internal reviews or audits of their quality assurance programs annually to ensure compliance with Good Laboratory Practice principles. It recommends verifying aspects of the quality assurance program such as having sufficient qualified personnel, conducting inspections according to plans, addressing deviations, and complying with policies and procedures. The reviews should be done by independent staff to avoid conflicts of interest, though the regulatory agency will take a pragmatic view for small facilities.
Aligning & implementation of ISO15189:2012 requirements in clinical laboratory includes enlisting & mapping the exact activities to be performed with each clause, having done the same it acts as a road map for monitoring & continuous improvement
This document discusses quality control and quality assurance in microbiological laboratory investigations. It emphasizes the importance of standard operating procedures, internal quality assessment, and external quality assessment. Quality control occurs at multiple stages of analysis, including pre-analytical (specimen collection and transport), analytical (reagents, equipment, procedures), and post-analytical (reporting and interpretation of results). A quality control officer oversees quality control in the department through regular monitoring, assessment, communication, and analysis of quality control data.
Role of hospital management related to patient safety in hospitals and the active roles played by them to improve patient safety. Details of actionable on part of hospital management pertaining to safety in hospitals.
The document discusses quality and quality assurance in healthcare. It defines quality as the degree to which health services increase desired health outcomes consistent with current knowledge. Quality assurance aims to promote the best possible patient care through ongoing evaluation. It ensures delivery of quality care and demonstrates efforts to provide the best results. Various methods are used to evaluate quality, including assessing structures, processes, and outcomes of care. Quality assurance is important to improve care, assess competence, and identify issues to correct.
This document discusses quality assurance in healthcare. It defines quality from different perspectives including the provider, manager, and client. It outlines 10 key steps in the quality assurance process: 1) Planning, 2) Developing guidelines and standards, 3) Communicating standards, 4) Monitoring quality, 5) Identifying problems, 6) Defining problems, 7) Choosing a team, 8) Analyzing problems, 9) Developing solutions, and 10) Implementing and evaluating improvements. It also discusses indicators for monitoring quality assurance like infection prevention, referral systems, and client satisfaction. Overall, the document provides an overview of the concepts, approaches, and factors involved in ensuring quality in healthcare.
This document discusses quality assurance in healthcare. It defines quality assurance as activities that contribute to defining, designing, assessing, monitoring, and improving quality of care. Quality assurance aims to meet customer expectations and improve credibility. Approaches to quality assurance include licensure to ensure minimum qualifications, accreditation for continuous improvement strategies, and certification to recognize excellence. Models used to evaluate quality include Donabedian's structure-process-outcome model, the tracer model focusing on process and outcomes, and the sentinel method measuring incidents related to quality.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Total quality management principles aim to improve patient care through monitoring laboratory work to detect deficiencies and correct them. Errors can occur in preanalytical, analytical, and postanalytical phases, and quality control procedures help control variables and ensure accuracy. Calibration, precision, accuracy, linearity, and detection limits are important analytical concepts, and factors like equipment, reagents, personnel, and documentation must be controlled and monitored to minimize errors and ensure quality.
This document provides an introduction to auditing and outlines key aspects of conducting an audit. It discusses the types of audits, including internal and external audits. The objectives of audits are to ensure compliance with cGMP guidelines and facilitate continuous quality improvement. Planning and preparation are important aspects, such as determining the audit scope and composing an audit team. The audit process involves opening and closing meetings, a facility tour, performing tests, and reporting findings. An auditor's responsibilities include researching issues, ensuring corrective actions, and establishing effective control systems. Deficiencies are classified as critical, major, or other based on their impact.
Improvement in process of Narcotic usage through Pre-filled syringessanobar77
To enhance the rational use of narcotics and minimizing the wastage through process
standardization and implementation of CPOE*, resulting in enhanced patient safety.
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
1. The document discusses various approaches to evaluating the success of a quality management system (QMS) in a hospital, including internal statistical analysis of performance indicators, external audits and accreditation, medical audits, nursing audits, equipment audits, and patient satisfaction surveys.
2. Key metrics for internal statistical evaluation include operational data like patient volumes, financial performance, and staff turnover. External evaluations involve inspections and accreditation from organizations like the ISO and Joint Commission International.
3. Regular patient satisfaction surveys provide direct feedback from patients and are considered the most effective evaluation approach.
The document discusses quality control and total quality management. It describes key thinkers in quality control like Deming, Juran, Crosby and their contributions. Some of the main points covered include defining quality as conformance to requirements, using statistical process control tools, and adopting the PDCA (plan-do-check-act) cycle. It also discusses the need for quality control in clinical laboratories to ensure accurate results and safe patient care. Quality assurance and quality control procedures help reduce errors and improve performance.
Quality assurance aims to ensure that pharmaceutical products meet the required quality standards for their intended use. It involves establishing standards and criteria for quality, collecting and analyzing information to assess quality, comparing the information to the criteria, making judgments about quality, and taking corrective actions if needed. Quality assurance considers all factors that can influence product quality, including raw materials, manufacturing processes, storage, distribution, and more. It is an ongoing cycle of evaluating and improving quality through research, development, documentation, facilities, equipment, and personnel. Quality assurance can be conducted internally or externally through independent assessors.
quality assurance slides include components, models, approaches, cycle of quality assurance is included in the slides.
the slide gives a brief ides regarding all the points and gives a comprehensive picture of the topic.
This document discusses quality assurance in nursing care. It introduces concepts of quality and quality assurance, and how they relate to health care. It describes general approaches to quality assurance like credentialing, licensure, accreditation and certification. Specific approaches discussed include peer review, using standards, and audits. Models of quality assurance and the ANA quality assurance model are presented. Factors affecting quality assurance in nursing care are outlined. Frameworks for quality assurance from various authors are summarized. Finally, the stages of developing international standards are described.
This document provides an overview of quality assurance and quality control processes in a clinical laboratory setting. It discusses key definitions of quality and quality management. It distinguishes between quality assurance and quality control, describing quality control as measurement to check analytical data quality while quality assurance guarantees integrity of overall data. The document outlines quality control selection criteria and evaluation methods. It also covers documentation requirements for a quality management system including classification of internal documents, external documents, and records.
The document discusses different types of audits conducted in the pharmaceutical industry including internal audits, external audits, and regulatory audits. It describes the objectives and processes involved in quality audits. Key points include:
1) Internal audits verify compliance and identify issues before external audits, external audits provide confidence in suppliers, and regulatory audits ensure legal compliance.
2) Audits examine facilities, documentation, practices, and more to evaluate adherence to GMP standards and identify needed improvements.
3) Benefits of audits include assuring GMP compliance, detecting potential problems, improving processes, and increasing management awareness.
Quality audits are systematic examinations to determine if activities comply with plans and regulations. Pharmaceutical manufacturers use audits to verify compliance with Good Manufacturing Practices (GMP). Audits have two goals - to verify manufacturing systems are controlled and to permit timely problem correction. Audits evaluate GMP compliance in production and quality control. They are performed routinely and in cases like recalls. Areas audited include personnel, facilities, equipment, production, quality control, documentation, and more. Audits are classified as internal, external, or regulatory. Internal audits ensure quality systems and identify pre-inspection problems. External audits reduce risk for partners. Regulatory audits build cooperation between authorities. Effective auditing requires qualified staff, documentation,
This document discusses quality assurance in hematology laboratories. It defines key terms like accuracy, precision, and components of quality assurance like pre-analytical, analytical, and post-analytical stages. It describes the importance of proper specimen collection and handling in the pre-analytical stage. The analytical stage involves internal and external quality control. Specific controls for hematology analyzers like Latron beads and 6C & retics controls are discussed. The importance of result verification, critical value notification, and collaboration in the post-analytical stage is highlighted. Calibration, proficiency testing, and the role of risk assessment in ensuring patient safety are also summarized.
This document provides an overview of quality assurance in healthcare. It discusses key concepts like continuous quality improvement and defines quality assurance. It outlines objectives of quality assurance like designing well-monitored processes to improve patient outcomes. Approaches covered include general approaches like credentialing, licensure, and accreditation, as well as specific approaches like audits and peer review. Models of quality assurance are presented, including the Donabedian model of structure, process and outcomes. Quality tools and the quality assurance cycle are also summarized.
Atanu Dutta is seeking a position in Quality Assurance with over 9 years of experience in pharmaceutical quality assurance and quality control. He has a Master's degree in Pharmaceutics and is currently working as Section Head of QMS & Compliance at Cipla Ltd., leading a team of 24 members. His responsibilities include quality operations planning and review, batch record review, internal audits, validation protocols, and ensuring deviations are investigated and resolved.
The document discusses key concepts related to quality assurance and total quality management (TQM). It defines quality, quality control, quality assurance, and quality management. It then discusses TQM in more detail, outlining its definition, objectives, principles, elements, barriers to implementation, and Deming's wheel for continuous improvement. The document also covers related terms like quality circles, quality improvement, and good manufacturing practices (GMPs), which help ensure consistent production of safe, high-quality products according to specifications.
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.
Quality control in a virology laboratory.pdfsamwel18
The document discusses quality control in virology laboratories. It defines quality control as measures taken during each assay to ensure tests are working properly, quality assurance as the overall program ensuring results are correct, and quality assessment as external evaluations of laboratory performance. It emphasizes the importance of quality control, quality assurance, and quality assessment programs in producing accurate and consistent diagnostic test results. Key aspects of these programs discussed include monitoring laboratory staff, equipment, record keeping, transcription accuracy, and following standard operating procedures. Quality control specifically refers to measures taken during each assay like using controls and following test protocols.
This study assessed adherence to USP 797 guidelines for sterile compounding at a hospital pharmacy. Technicians and nurses were observed compounding medications and their techniques were analyzed using a gap analysis. Pre-intervention quiz scores showed gaps in understanding guidelines. A presentation highlighting these gaps significantly improved post-intervention quiz scores. The majority of guidelines in cleaning areas were not followed. Identifying specific problems and educating staff on proper procedures can improve sterile compounding techniques and patient outcomes.
The document discusses quality and quality assurance in healthcare. It defines quality as the degree to which health services increase desired health outcomes consistent with current knowledge. Quality assurance aims to promote the best possible patient care through ongoing evaluation. It ensures delivery of quality care and demonstrates efforts to provide the best results. Various methods are used to evaluate quality, including assessing structures, processes, and outcomes of care. Quality assurance is important to improve care, assess competence, and identify issues to correct.
This document discusses quality assurance in healthcare. It defines quality from different perspectives including the provider, manager, and client. It outlines 10 key steps in the quality assurance process: 1) Planning, 2) Developing guidelines and standards, 3) Communicating standards, 4) Monitoring quality, 5) Identifying problems, 6) Defining problems, 7) Choosing a team, 8) Analyzing problems, 9) Developing solutions, and 10) Implementing and evaluating improvements. It also discusses indicators for monitoring quality assurance like infection prevention, referral systems, and client satisfaction. Overall, the document provides an overview of the concepts, approaches, and factors involved in ensuring quality in healthcare.
This document discusses quality assurance in healthcare. It defines quality assurance as activities that contribute to defining, designing, assessing, monitoring, and improving quality of care. Quality assurance aims to meet customer expectations and improve credibility. Approaches to quality assurance include licensure to ensure minimum qualifications, accreditation for continuous improvement strategies, and certification to recognize excellence. Models used to evaluate quality include Donabedian's structure-process-outcome model, the tracer model focusing on process and outcomes, and the sentinel method measuring incidents related to quality.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Total quality management principles aim to improve patient care through monitoring laboratory work to detect deficiencies and correct them. Errors can occur in preanalytical, analytical, and postanalytical phases, and quality control procedures help control variables and ensure accuracy. Calibration, precision, accuracy, linearity, and detection limits are important analytical concepts, and factors like equipment, reagents, personnel, and documentation must be controlled and monitored to minimize errors and ensure quality.
This document provides an introduction to auditing and outlines key aspects of conducting an audit. It discusses the types of audits, including internal and external audits. The objectives of audits are to ensure compliance with cGMP guidelines and facilitate continuous quality improvement. Planning and preparation are important aspects, such as determining the audit scope and composing an audit team. The audit process involves opening and closing meetings, a facility tour, performing tests, and reporting findings. An auditor's responsibilities include researching issues, ensuring corrective actions, and establishing effective control systems. Deficiencies are classified as critical, major, or other based on their impact.
Improvement in process of Narcotic usage through Pre-filled syringessanobar77
To enhance the rational use of narcotics and minimizing the wastage through process
standardization and implementation of CPOE*, resulting in enhanced patient safety.
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
1. The document discusses various approaches to evaluating the success of a quality management system (QMS) in a hospital, including internal statistical analysis of performance indicators, external audits and accreditation, medical audits, nursing audits, equipment audits, and patient satisfaction surveys.
2. Key metrics for internal statistical evaluation include operational data like patient volumes, financial performance, and staff turnover. External evaluations involve inspections and accreditation from organizations like the ISO and Joint Commission International.
3. Regular patient satisfaction surveys provide direct feedback from patients and are considered the most effective evaluation approach.
The document discusses quality control and total quality management. It describes key thinkers in quality control like Deming, Juran, Crosby and their contributions. Some of the main points covered include defining quality as conformance to requirements, using statistical process control tools, and adopting the PDCA (plan-do-check-act) cycle. It also discusses the need for quality control in clinical laboratories to ensure accurate results and safe patient care. Quality assurance and quality control procedures help reduce errors and improve performance.
Quality assurance aims to ensure that pharmaceutical products meet the required quality standards for their intended use. It involves establishing standards and criteria for quality, collecting and analyzing information to assess quality, comparing the information to the criteria, making judgments about quality, and taking corrective actions if needed. Quality assurance considers all factors that can influence product quality, including raw materials, manufacturing processes, storage, distribution, and more. It is an ongoing cycle of evaluating and improving quality through research, development, documentation, facilities, equipment, and personnel. Quality assurance can be conducted internally or externally through independent assessors.
quality assurance slides include components, models, approaches, cycle of quality assurance is included in the slides.
the slide gives a brief ides regarding all the points and gives a comprehensive picture of the topic.
This document discusses quality assurance in nursing care. It introduces concepts of quality and quality assurance, and how they relate to health care. It describes general approaches to quality assurance like credentialing, licensure, accreditation and certification. Specific approaches discussed include peer review, using standards, and audits. Models of quality assurance and the ANA quality assurance model are presented. Factors affecting quality assurance in nursing care are outlined. Frameworks for quality assurance from various authors are summarized. Finally, the stages of developing international standards are described.
This document provides an overview of quality assurance and quality control processes in a clinical laboratory setting. It discusses key definitions of quality and quality management. It distinguishes between quality assurance and quality control, describing quality control as measurement to check analytical data quality while quality assurance guarantees integrity of overall data. The document outlines quality control selection criteria and evaluation methods. It also covers documentation requirements for a quality management system including classification of internal documents, external documents, and records.
The document discusses different types of audits conducted in the pharmaceutical industry including internal audits, external audits, and regulatory audits. It describes the objectives and processes involved in quality audits. Key points include:
1) Internal audits verify compliance and identify issues before external audits, external audits provide confidence in suppliers, and regulatory audits ensure legal compliance.
2) Audits examine facilities, documentation, practices, and more to evaluate adherence to GMP standards and identify needed improvements.
3) Benefits of audits include assuring GMP compliance, detecting potential problems, improving processes, and increasing management awareness.
Quality audits are systematic examinations to determine if activities comply with plans and regulations. Pharmaceutical manufacturers use audits to verify compliance with Good Manufacturing Practices (GMP). Audits have two goals - to verify manufacturing systems are controlled and to permit timely problem correction. Audits evaluate GMP compliance in production and quality control. They are performed routinely and in cases like recalls. Areas audited include personnel, facilities, equipment, production, quality control, documentation, and more. Audits are classified as internal, external, or regulatory. Internal audits ensure quality systems and identify pre-inspection problems. External audits reduce risk for partners. Regulatory audits build cooperation between authorities. Effective auditing requires qualified staff, documentation,
This document discusses quality assurance in hematology laboratories. It defines key terms like accuracy, precision, and components of quality assurance like pre-analytical, analytical, and post-analytical stages. It describes the importance of proper specimen collection and handling in the pre-analytical stage. The analytical stage involves internal and external quality control. Specific controls for hematology analyzers like Latron beads and 6C & retics controls are discussed. The importance of result verification, critical value notification, and collaboration in the post-analytical stage is highlighted. Calibration, proficiency testing, and the role of risk assessment in ensuring patient safety are also summarized.
This document provides an overview of quality assurance in healthcare. It discusses key concepts like continuous quality improvement and defines quality assurance. It outlines objectives of quality assurance like designing well-monitored processes to improve patient outcomes. Approaches covered include general approaches like credentialing, licensure, and accreditation, as well as specific approaches like audits and peer review. Models of quality assurance are presented, including the Donabedian model of structure, process and outcomes. Quality tools and the quality assurance cycle are also summarized.
Atanu Dutta is seeking a position in Quality Assurance with over 9 years of experience in pharmaceutical quality assurance and quality control. He has a Master's degree in Pharmaceutics and is currently working as Section Head of QMS & Compliance at Cipla Ltd., leading a team of 24 members. His responsibilities include quality operations planning and review, batch record review, internal audits, validation protocols, and ensuring deviations are investigated and resolved.
The document discusses key concepts related to quality assurance and total quality management (TQM). It defines quality, quality control, quality assurance, and quality management. It then discusses TQM in more detail, outlining its definition, objectives, principles, elements, barriers to implementation, and Deming's wheel for continuous improvement. The document also covers related terms like quality circles, quality improvement, and good manufacturing practices (GMPs), which help ensure consistent production of safe, high-quality products according to specifications.
A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization (i.e., areas that can impact the organization’s ability to meet customer requirements). ISO 9001 is an example of a Quality Management System.
Quality control in a virology laboratory.pdfsamwel18
The document discusses quality control in virology laboratories. It defines quality control as measures taken during each assay to ensure tests are working properly, quality assurance as the overall program ensuring results are correct, and quality assessment as external evaluations of laboratory performance. It emphasizes the importance of quality control, quality assurance, and quality assessment programs in producing accurate and consistent diagnostic test results. Key aspects of these programs discussed include monitoring laboratory staff, equipment, record keeping, transcription accuracy, and following standard operating procedures. Quality control specifically refers to measures taken during each assay like using controls and following test protocols.
This study assessed adherence to USP 797 guidelines for sterile compounding at a hospital pharmacy. Technicians and nurses were observed compounding medications and their techniques were analyzed using a gap analysis. Pre-intervention quiz scores showed gaps in understanding guidelines. A presentation highlighting these gaps significantly improved post-intervention quiz scores. The majority of guidelines in cleaning areas were not followed. Identifying specific problems and educating staff on proper procedures can improve sterile compounding techniques and patient outcomes.
Quality Control.pptx leadership and managementAlaaShosha7
This document outlines a lecture on quality control. It begins with definitions of key terms like quality control and discusses why quality control is needed to ensure product safety and avoid liability. It then describes the quality control process, including establishing standards, collecting relevant information, evaluating performance, and reevaluation. An example of quality control in hospitals is given around glucose testing and patient identification standards. The document stresses that everyone in an organization should be involved in quality control. It provides steps to implement a program and explains the nurse manager's role in encouraging involvement, communicating standards, and using audits to improve quality of care.
Improving Lab Order, Verification, and Follow-up Processes at UT PhysiciansAllison McCoy
We retrieved electronic health record data on lab order, verification, and follow-up processes at UT Physicians and developed a dashboard to describe metrics for evaluating these processes. A two-month pilot evaluation of one department indicates some room for improvement in standardizing and improving processes to improve quality of care, patient safety, and satisfaction.
The document discusses various management techniques that can be used to improve healthcare delivery and lower costs. These include PDCA (Plan-Do-Check-Act) cycle, Six Sigma, balanced scorecard, Lean methodology, business process reengineering, and benchmarking. Case studies are provided that demonstrate how these techniques were used to reduce prolonged hospital stays, delays in lab and ultrasound reports, and surgical infections.
This document discusses quality control in histopathology. It defines key terms like quality control, quality assurance, and total quality management. It outlines the pre-analytical, analytical and post-analytical phases of quality control and highlights variables that can affect quality in each phase like personnel training, equipment, and interpretation of results. It provides recommendations for achieving quality control through standardized procedures, monitoring turnaround times, participation in proficiency testing, and review of reports. The goal is to generate accurate histopathology reports and enable easy retrieval if needed.
Presentation given to Pharmacy Technician students on career profiles: Aseptic Unit- Jennifer O\'Meara, Ward ased Technician (WBT) - Caroline McLoughlin, Clinical Trials - Sharon Curran-Rae & Purchasing - Yvonne Sheehan
Quality refers to doing things right the first time according to established requirements and standards. It involves accuracy, reliability, and timeliness of laboratory test results. Quality control monitors performance against standards, quality assurance refers to all operational aspects, and quality management involves determining policy objectives and implementing quality planning, control, and improvement. Laboratory accreditation in India is administered by the National Accreditation Board for Testing and Calibration Laboratories (NABL) based on the ISO 15189 standard, which specifies requirements for quality and competence in medical laboratories. The quality management system involves establishing essential elements like organization, customer focus, facilities management, and processes to assure quality.
The document discusses various aspects of validation in the pharmaceutical industry. It begins with introducing validation and its importance in assuring quality of pharmaceutical products. It then covers topics such as validation planning, documentation, validation master plan, types of validation including process, cleaning and equipment validation. The document also discusses ICH and WHO guidelines for validation. It highlights the need, merits and demerits of validation as well as who performs validation activities. Finally, it provides an overview of prospective, retrospective and concurrent validation approaches.
This document summarizes a proposed Patient Blood Management (PBM) program at St. Elsewhere Hospital. It identifies issues with current transfusion practices and policies across three pilot areas: post-partum haemorrhage, pre-operative optimization of haemoglobin levels, and deployment of intraoperative cell salvage. The program proposes applying ISO 9001 quality management standards to establish a PBM quality system and governance structure to standardize practices, reduce unnecessary transfusions, and improve outcomes. Key elements include developing a PBM committee, validating all clinical policies, establishing responsibilities and trainings, and deploying alternatives to transfusion like intraoperative cell salvage. The flexibility of ISO 9001 makes it suitable to implement across complex healthcare organizations
An electronic patient flow-board was implemented in an oncology clinic to improve communication and workflow. A study measured the impact and found that pharmacists spent less time managing nurse queries, with their time decreasing from 2.8 hours to less than 0.5 hours per week. Chemotherapy wastage was also reduced by 91.6% due to fewer cancelled or delayed treatments. Staff surveys indicated that the flow-board improved communication and patient care. The conclusion is that the electronic board improved efficiency and decreased patient waiting times by enhancing communication and reducing wasted medications.
Challenges in quality management of diagnostic medical imagingMohammad Fathi
Key challenges in quality management of diagnostic medical imaging departments include developing methods to collect and deliver knowledge about quality care to practitioners. Quality consists of technical outcome and service delivery. Key performance indicators used are customer satisfaction, patient access to appointments, and reporting time. Measuring and monitoring quality indicators is important to prove high quality imaging services. Maintaining good employee and departmental policies is also important for quality management.
This response from the Quality Assurance Manager addresses concerns raised in a warning letter from the FDA regarding three observations: (1) lack of adequate qualified personnel, (2) failure to establish time limits for production phases, and (3) lack of strict control over labeling. For each observation, the response provides corrective actions taken, preventative actions implemented, and an expected completion date of two months from the warning letter date. The overall tone is one of commitment to addressing the issues and ensuring compliance with regulations to protect patient safety.
Study on the Impact of FOCUS-PDCA Management Model on the Disinfection Qualit...MehranMouzam
To analyze the impact of FOCUS-PDCA management model on the disinfection quality of flexible endoscopes. Method: A study was conducted on 128 flexible endoscopes in our hospital. According to different management plans, flexible endoscopes were divided into a control group (conventional management model) and an experimental group (FOCUS-PDCA management model). The flexible endoscopes evaluated in both control group and the experimental group were 64 each. The ATP values, management quality, and bacterial colony exceeding standards were observed in two groups. Results: Before management, there was no significant difference in ATP values between the two groups, with P>0.05; after management, compared with the control group (106.25 ± 6.812), the ATP value in the experimental group was lower, with P<0.05. The scores of disinfection standards (4.39 ± 0.49), cleaning standards (4.22 ± 0.45), management systems (4.13 ± 0.34), and management assessment (4.97 ± 0.25) in the experimental group were higher than those in the control group (3.89 ± 0.31, 3.20 ± 0.41, 3.12 ± 0.13, 3.95 ± 0.21), with P<0.05. In the experimental group, the bacterial colony exceeding standard rate of gastroscopy was 3.13%, bacterial colony exceeding standard rate of colonoscopy was 0.00%, bacterial colony exceeding standard rate of bronchoscopy was 1.56%, and the total bacterial colony exceeding standard rate of total colonies was 6.25%, which were significantly lower than the control group's 12.50%, 7.81%, 12.50%, and 32.81%, respectively with P<0.05. Conclusion: The FOCUS-PDCA management model is more conducive to reducing the ATP values of flexible endoscopes, improving the disinfection qualification rate, and improving management quality. This model is worthy of further promotion.
Executive Certificate Program in Pharmacovigilance Audits and Inspections (Live eLearning), offered jointly by Cliniminds and CRQA, a leading global GxP Audits company.
This unique program is designed to equip participants with the essential knowledge and skills required to excel in pharmacovigilance audits and inspection preparedness. including regulatory requirements, audit methodologies, risk assessment, and best practices in pharmacovigilance.
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info@cliniminds.com, www.cliniminds.com
This document discusses concepts of change control, out of specifications (OOS), and out of trends (OOT) in pharmaceutical quality assurance. It defines change control as a procedure to review, verify, regulate, manage, approve and control changes made to systems or processes. OOS refers to test results that fall outside pre-defined acceptance criteria, while OOT describes results that do not follow expected trends. The document outlines procedures for investigating and managing changes, OOS, and OOT to ensure product quality and compliance with regulations.
The document discusses performance evaluation of hospitals, which is essential to ensure health services are effective and efficiently using limited resources. It describes evaluating hospitals based on the amount and quality of work, costs, and patient satisfaction. Performance is evaluated through indicators to identify areas for improvement. Methods include indirect analysis of factors influencing care quality and direct analysis of medical records. Clinical audits also evaluate patterns of care quality and resources usage by analyzing topics like diagnostic tests, medical records, and patient satisfaction. The goal is continuously improving patient care and outcomes.
This document defines quality assurance and its purpose in healthcare. It discusses evaluating the structure, process, and outcomes of care delivery. Quality assurance aims to continuously improve care quality through ongoing evaluation and promotion of excellence. It assesses staff competence and notifies administrators of deficiencies to correct. Methods include concurrent and retrospective reviews to allow simultaneous corrective action or in-depth assessments after discharge. The quality assurance committee coordinates these efforts.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
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Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
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8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.