Fusion quality assurance. (1)
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Fusion is establishing a central Quality Assurance function to ensure integrity across its partnership members and provide audit and review processes as a business activity. Chakrapani Majumdar will head this function, bringing experience from roles in the pharmaceutical industry. The Quality Assurance Group will offer services like clinical quality assurance support, quality management system design, computer system validation support, GCP and GLP audits, and training program design support.
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The document describes GMP Compliance Consultants, a team of experts providing quality and compliance consulting services to the pharmaceutical and food supplement industries. They have a team of over 15 highly experienced individuals with over 350 years of combined experience across areas like quality assurance, validation, technology transfer, and regulatory compliance. They offer a wide range of services including project management, technology transfer, validation, quality system implementation, auditing, investigations, and training. Their goal is to help clients ensure their products and services meet regulatory standards through reliable, knowledgeable expertise.
Total quality management
This document provides an overview of Total Quality Management (TQM). It defines TQM as continuously improving quality through a focus on customer requirements, improving related processes, and involving all employees. The document outlines key TQM concepts like customer focus, continuous improvement, and employee empowerment. It also discusses quality gurus like Deming and his 14 points. Quality tools covered include PDCA cycles, seven quality tools, and managing supplier quality.
AUDIT MATURITY MODEL
Today it is crucial for organizations to pay even greater attention on quality management as the
importance of this function in achieving ultimate business objectives is increasingly becoming
clearer. Importance of the Quality Management (QM) Function in achieving basic need by
ensuring compliance with Capability Maturity Model Integrated (CMMI) / International
Organization for Standardization (ISO) is a basic demand from business nowadays. However,
QM Function and its processes need to be made much more mature to prevent delivery outages
and to achieve business excellence through their review and auditing capability. Many
organizations now face challenges in determining the maturity of the QM group along with the
service offered by them and the right way to elevate the maturity of the same. The objective of
this whitepaper is to propose a new model –the Audit Maturity Model (AMM) which will
provide organizations with a measure of their maturity in quality management in the perspective
of auditing, along with recommendations for preventing delivery outage, and identifying risk to
achieve business excellence. This will enable organizations to assess QM maturity higher than
basic hygiene and will also help them to identify gaps and to take corrective actions for
achieving higher maturity levels. Hence the objective is to envisage a new auditing model as a
part of organisation quality management function which can be a guide for them to achieve
higher level of maturity and ultimately help to achieve delivery and business excellence.
QC QA VALIDATION.pptx
This document discusses quality control, quality assurance, and validation processes in pharmaceutical manufacturing. It defines key terms like QA, QC, cGMP, and describes the three stages of process validation. Quality systems help ensure safety and effectiveness through management responsibilities, resources, manufacturing operations, and evaluation activities. Adhering to cGMP regulations and maintaining a robust quality system leads to consistent production of quality products.
Quality Management System A Much Needed Tool to Ensure Total Quality Management
The demand for quality products in the market has increased drastically in the past several decades. Thus, to survive in the competitive world it has become very important for every organization to have a well structured and planned management system. The system encompasses all aspects, it not only works outside the organization but also strengthens the core and delivers a top quality product to the end user. In order to deliver the top notch product total quality management has merged out of the quality management system and has enhanced the efficiency of the organization to produce a quality product to many folds. Quality management system along with the total quality management leads the organization to reach the zenith of zero percent defect and hundred percent customer satisfaction. This review article helps you to understand the intertwined concept of the quality management system and total quality system within the organization. They both share the same vision of customer satisfaction by producing the top quality product yet work on different levels to achieve it by using different techniques. Ms. Soumya Pathak | Ms. Swarnima Negi | Dr. Sachdev Yadav "Quality Management System: A Much-Needed Tool to Ensure Total Quality Management" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-3 , April 2021, URL: https://www.ijtsrd.com/papers/ijtsrd39975.pdf Paper URL: https://www.ijtsrd.com/management/management-development/39975/quality-management-system-a-muchneeded-tool-to-ensure-total-quality-management/ms-soumya-pathak
Quality assurance and quality management concepts ppt.pptx
quality control tools, NABL, ISO 9000, ISO 14000 , total quality management, quality by design, ICH guidelines
Manano 2
An organization can benefit from establishing an effective quality management system (QMS) to ensure customer requirements are consistently met. A QMS coordinates activities to continually improve performance by defining processes that produce quality products and services. Implementing a QMS involves designing, building, controlling, deploying, measuring, reviewing, and improving the system. Certification of a QMS by an independent third party can provide assurance to customers and improve an organization's competitiveness.
Finalreport 130821121835-phpapp01
The document discusses concepts from quality gurus like Deming, Juran, Crosby, Feigenbaum and Ishikawa that form the foundation of Total Quality Management (TQM). It outlines Deming's 14 points for management and his Plan-Do-Study-Act cycle for continuous improvement. Juran believed quality problems stem from management and achieving quality requires activities across all firm functions. He defined four categories of quality costs to evaluate costs related to quality.
Total Quality Management (Ankit Rana)
Total Quality Management (TQM) is an approach that aims to prevent defects by integrating quality improvement into all business processes. TQM focuses on customer satisfaction and continuous improvement through management commitment, employee empowerment, and fact-based decision making. The key principles of TQM include making quality the top priority, involving all employees, focusing on processes, and taking a strategic, systematic approach to improvement.
How to Implement and Maintain an Audit-Ready QMS Leveraging Technology
Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better.
Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies.
So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors.
• Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy
• How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker
• How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820
• How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator
• How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Different Types of QA Methods.pdf
Incorporated in 2017, Polyxer Systems is an outsourcing and technology consultancy based in Ahmedabad, Gujarat, India.
From concept to market, we specialize in designing and building tailor-made mobile and cloud software solutions that help businesses unlock growth.
We have valuable experience working with diverse sectors and world-class expertise in software development using Various Technology Stack.
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA
This document describes a leading clinical research organization that wanted to enhance its compliance and quality management. It was manually conducting audit and corrective action processes using spreadsheets, which led to inefficiencies. It implemented the MetricStream solution to automate audit management and corrective action planning. This streamlined processes, provided better visibility and reporting, and helped ensure compliance with various regulations. The automated solution reduced cycle times and audit costs while improving precision and productivity.
Similar to Fusion quality assurance. (1) (20)
A Review of the Concept of ISO Standard 9000 Family
A Review of the Concept of ISO Standard 9000 Family
Benefits and best practices outsource quality assurance
Benefits and best practices outsource quality assurance
Quality Management System A Much Needed Tool to Ensure Total Quality Management
Quality Management System A Much Needed Tool to Ensure Total Quality Management
Quality assurance and quality management concepts ppt.pptx
Quality assurance and quality management concepts ppt.pptx
How to Implement and Maintain an Audit-Ready QMS Leveraging Technology
How to Implement and Maintain an Audit-Ready QMS Leveraging Technology
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA
Clinical Research Org. Intensifies Compliance by Automating Audit & CAPA
Fusion quality assurance. (1)
- 1. Fusion Pharmacology Fusion Quality Assurance. It is essential for the integrity of the partnership of Fusion that the members have a common core of Quality Assurance which ensures that each of the members is currently compliant with its own SOPs and yet at the same time, the individual corporate quality infrastructure is consistent throughout and that there are no conflicting practices. To this end, Fusion is evolving a central Quality Assurance function concerned with ensuring this integrity and at the same time providing on a contract basis the essential audit and review processes. These will be central to all Fusion programmes but may also be a business activity in its own right and so may be contracted independently when a client has a need. Chakrapani Majumdar, Head of QA for Veeda Clinical Research heads up and co-ordinates this function. Mr Majumdar has worked in a number of roles in the pharmaceutical industry both within CROs and also with MNCs including Novartis, Ranbaxy and Zydus Cadilla. Described by one MNC during an audit as running ‘the best QA department that they had met in the industry’ it is a pleasure to welcome Chakrapani to the Fusion Alliance. The services to be offered by the Fusion Quality Assurance Group are specifically defined to meet the needs of our target client-base and include: • Clinical Quality Assurance Support. • QMS design and management support • CSV; Computer System Validation Support. GCP and GLP Audit Support. • Specialised Audit Support for Clinical Data Management, EDC audits, Site audits and Generic Study Audits. • Training Programme Design Support and Document Management Support. If you wish to discuss any of the above matters then please initially direct your enquiries to to Chakrapani at Chakrapani.Majumdar@fusionseasia.com Elizabeth Stevens e-mail Elizabeth Stevens @galenguernsey.gg or tel +971 989 9258 Yvonne Lungershausen e-mail Yvonne.Lungershausen@cprservices.com.au or tel +61 8 8125 1900