Harpreet Singh is seeking a position in the pharma industry utilizing 19 years of experience in areas like equipment validation, production, quality assurance, training and regulatory compliance. He has hands-on experience with FDA, EU, WHO and other regulatory guidelines. Key projects include setting up a new spray dryer plant and qualifying a microbiology lab. He is proficient in systems like SAP, MS Office and learning management systems.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
This document outlines the process and considerations for pilot plant scale-up of pharmaceutical manufacturing. It defines a pilot plant as transforming a lab-scale formula into a viable product through developing a reliable manufacturing procedure. The objectives of a pilot plant are to produce stable dosage forms, review equipment, establish production guidelines and controls, evaluate and validate processes and equipment, and determine a master manufacturing formula. Key steps involve reviewing the formula, approving raw materials, selecting appropriate sized equipment, determining production rates, developing standard operating procedures, and conducting stability testing. Personnel with both scientific and engineering knowledge are needed, and facilities must allow for physical testing, equipment, raw materials storage, and record keeping. Adherence to good manufacturing practices is also important for a
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
The document discusses pharmaceutical process validation. It defines validation as proving a process consistently produces quality products. There are three main types of validation: prospective validation done before use, retrospective using historical data, and concurrent during routine production. Validation ensures quality, reduces costs, and meets regulations. It involves qualification of facilities and equipment, then protocols to test processes over multiple batches and demonstrate control. Periodic revalidation is also required when changes are made.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
This document provides definitions and information related to computer system validation (CSV) concepts in the pharmaceutical industry. It defines key terms like CSV, data integrity, GxP compliance, regulations, guidelines, directives, and regulatory bodies. These include the US FDA, CDSCO, EMA, PIC/S, ICH, and WHO. The document also explains concepts such as regulatory affairs, computerized systems, validation, verification, qualification, and documentation like forms 482 and 483. It provides descriptions of deviation, incidents, out of specification results, change control, and corrective and preventive action. Finally, it discusses user requirements specifications and the qualification stages of design, installation, operational and performance qualification.
The document provides details about an expert in managing factory operations and ensuring quality compliance. Some key experiences include overseeing production processes, quality management systems, statutory compliance, and international product registrations. The professional has over 30 years of experience in research and development, quality assurance, and environmental assessments across various roles within the agrochemical industry.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
This document outlines the process and considerations for pilot plant scale-up of pharmaceutical manufacturing. It defines a pilot plant as transforming a lab-scale formula into a viable product through developing a reliable manufacturing procedure. The objectives of a pilot plant are to produce stable dosage forms, review equipment, establish production guidelines and controls, evaluate and validate processes and equipment, and determine a master manufacturing formula. Key steps involve reviewing the formula, approving raw materials, selecting appropriate sized equipment, determining production rates, developing standard operating procedures, and conducting stability testing. Personnel with both scientific and engineering knowledge are needed, and facilities must allow for physical testing, equipment, raw materials storage, and record keeping. Adherence to good manufacturing practices is also important for a
This document discusses validation concepts including user requirement specification, phases of validation such as design qualification, installation qualification, operational qualification, performance qualification, and maintenance qualification. It provides definitions and guidelines for each phase. The key phases involve design qualification to define functional specifications, installation qualification to ensure proper installation, operational qualification to test functions, performance qualification to ensure consistent performance over time, and maintenance qualification to document maintenance. The overall goal of validation is to provide high assurance that a process will consistently produce quality products meeting specifications.
The document discusses pharmaceutical process validation. It defines validation as proving a process consistently produces quality products. There are three main types of validation: prospective validation done before use, retrospective using historical data, and concurrent during routine production. Validation ensures quality, reduces costs, and meets regulations. It involves qualification of facilities and equipment, then protocols to test processes over multiple batches and demonstrate control. Periodic revalidation is also required when changes are made.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
This document provides definitions and information related to computer system validation (CSV) concepts in the pharmaceutical industry. It defines key terms like CSV, data integrity, GxP compliance, regulations, guidelines, directives, and regulatory bodies. These include the US FDA, CDSCO, EMA, PIC/S, ICH, and WHO. The document also explains concepts such as regulatory affairs, computerized systems, validation, verification, qualification, and documentation like forms 482 and 483. It provides descriptions of deviation, incidents, out of specification results, change control, and corrective and preventive action. Finally, it discusses user requirements specifications and the qualification stages of design, installation, operational and performance qualification.
The document provides details about an expert in managing factory operations and ensuring quality compliance. Some key experiences include overseeing production processes, quality management systems, statutory compliance, and international product registrations. The professional has over 30 years of experience in research and development, quality assurance, and environmental assessments across various roles within the agrochemical industry.
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
Quality Assurance Services, Inc. provides quality assurance services including receiving inspection, containment, sorting, inspection, rework, repair, and warehousing for customers. Its mission is to be a successful supplier committed to continuous improvement, customer satisfaction, employee development, long-term partnerships, growth and profitability. It aims to be the industry leader in quality services through strategic partnerships. The company orients its processes around customer requirements and satisfaction through effective inspection, containment of non-conforming products, and meeting production schedules.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
The document provides information on documentation in the pharmaceutical industry including:
1. It emphasizes the importance of documentation for industries and describes protocols regarding documentation and their management.
2. Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. It provides a route for auditors to assess quality operations.
3. The most common types of documents used for GMP are described, including quality manuals, standard operating procedures, batch records, test methods, and specifications.
This document discusses the purpose and operation of a pilot plant in the pharmaceutical industry. It states that a pilot plant allows investigation of a product and process on an intermediate scale before large-scale production is committed to. This helps evaluate results from laboratory studies, produce small quantities of product for testing, and provide data to determine if full-scale production is viable. The document outlines considerations for personnel, space, equipment, raw materials, and production rates in setting up a pilot plant.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
This document provides an overview of CGMP (Current Good Manufacturing Practice) and industrial management. It discusses key aspects of CGMP such as plant layout, services, equipment, production organization, materials management, handling and transportation, inventory management, production planning and control, sales forecasting, budgeting, quality management, and industrial relationships. The objectives of CGMP are to ensure product quality and consistency in manufacturing. Key elements outlined include facilities and equipment requirements, quality control of materials, production systems, and regulatory compliance.
The document provides a summary of Joseph E. Mack Jr.'s qualifications for a Quality Assurance position. He has over 10 years of experience in Quality Assurance and Quality Control, including being a Certified Quality Auditor. He has extensive knowledge of cGMP regulations and experience auditing both internal and external processes. Currently he is the GMP QA Manager at Cambridge Isotope Laboratories where he oversees the Quality System and ensures compliance.
The document discusses validation in the pharmaceutical industry. It defines validation according to WHO, US FDA, and ICH and explains the need, importance, scope and types of validation. The main types discussed are process validation, cleaning validation, equipment validation, and validation of analytical methods. Documentation for validation includes the validation master plan, validation protocols and reports, and standard operating procedures. Qualification is also discussed as being related to but distinct from validation, involving design, installation, operational and performance qualification of equipment.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
This document discusses pilot plant design, operation, and scale up considerations for pharmaceutical manufacturing processes. It provides an overview of the need for pilot plants and scale up to transfer processes from the laboratory to production scale. Key sections include descriptions of pilot plant attributes, operational aspects like validation and training, scale up principles of similarity, and development milestones from formulation through clinical and commercial production. Process parameters that should be evaluated at various stages like mixing, drying, milling and compression are also outlined.
Terry Nicholas is a quality assurance professional with over 30 years of experience in manufacturing industries including aerospace, precision engineering, food packaging, automotive components, and more. He has extensive experience maintaining and achieving accreditations like ISO 9000, AS9100, and BRC/IOP. His background includes roles as quality manager, quality engineer, root cause analysis, audit lead, and training. He has worked to improve quality systems and processes for companies in aerospace, banking/cards, injection molding, printing, and other sectors.
Jose Falcon has over 15 years of experience in manufacturing and quality assurance roles in the medical device and pharmaceutical industries. He has a strong background in quality system regulations and statistical process control. Currently he is a Senior Manufacturing Supervisor at St. Jude Medical, where he has improved productivity by 15% and reduced excess inventory levels. Previously he held supervisory roles at Cardinal Health and Ethicon, where he implemented lean initiatives and electronic systems to improve efficiency.
This document is a resume for Mayra I. Casiano summarizing her experience in the medical device and pharmaceutical industries. She has over 20 years of experience in manufacturing, process/packaging, technical services, and validation. Some of her responsibilities have included leading manufacturing operations, implementing technology transfers, ensuring regulatory compliance, and authoring standard operating procedures. She is proficient in validation protocols for facilities, equipment, and processes.
Lisa Burdick has over 15 years of experience in quality and regulatory roles within ISO 13485 and FDA regulated environments. She has extensive experience with quality documentation, lot release, sterilization processes, auditing, and calibration systems. Currently she works as a Senior Quality Systems Specialist at Valeritas, where she manages lot release, sterilization processes, documentation systems, auditing, and corrective and preventative action programs.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
This document provides guidelines for process validation of pharmaceutical dosage forms issued by the Saudi Food and Drug Authority (SFDA). It outlines three stages of validation: process design, process qualification, and continued process verification. The guidelines describe the principles and approaches for validation, including qualification, protocols, reports, and management of changes. Process validation aims to ensure manufacturing processes are capable of consistently producing products of the required quality.
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
M. Srinivasan is an experienced Operations Manager with over 18 years of experience in pharmaceutical manufacturing. He has a strong background in production planning and quality assurance. Srinivasan is looking for new opportunities to utilize his skills in operations management, process improvement, quality audits, and machinery maintenance. He has worked for several major pharmaceutical companies and has experience managing facilities, projects, and over 400 employees.
It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable and practical procedure of manufacture.
Objectives and policies of cGMP & Inventory management and controlArul Packiadhas
This document discusses objectives and policies of CGMP (current good manufacturing practices) and inventory management and control. It outlines the importance of CGMP in assuring quality standards and preventing issues. CGMP regulations provide systems to properly design, monitor, and control manufacturing processes. The document also describes objectives of inventory control such as minimizing costs and ensuring adequate stock levels. It provides details on inventory management policies, documentation requirements, and quality control standards under CGMP.
Quality Assurance Services, Inc. provides quality assurance services including receiving inspection, containment, sorting, inspection, rework, repair, and warehousing for customers. Its mission is to be a successful supplier committed to continuous improvement, customer satisfaction, employee development, long-term partnerships, growth and profitability. It aims to be the industry leader in quality services through strategic partnerships. The company orients its processes around customer requirements and satisfaction through effective inspection, containment of non-conforming products, and meeting production schedules.
This document outlines validation and calibration master plans. It discusses the objectives of validation including reducing risks and costs. It describes the contents and members involved in a validation master plan, which provides the framework for validation activities. It also discusses the calibration process, including defining calibrated equipment, classification, and verification. The calibration master plan establishes requirements for an effective calibration control program.
The document provides information on documentation in the pharmaceutical industry including:
1. It emphasizes the importance of documentation for industries and describes protocols regarding documentation and their management.
2. Documentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. It provides a route for auditors to assess quality operations.
3. The most common types of documents used for GMP are described, including quality manuals, standard operating procedures, batch records, test methods, and specifications.
This document discusses the purpose and operation of a pilot plant in the pharmaceutical industry. It states that a pilot plant allows investigation of a product and process on an intermediate scale before large-scale production is committed to. This helps evaluate results from laboratory studies, produce small quantities of product for testing, and provide data to determine if full-scale production is viable. The document outlines considerations for personnel, space, equipment, raw materials, and production rates in setting up a pilot plant.
This document discusses change control in the pharmaceutical industry. It defines change and change control, and outlines the tasks, principles, regulatory requirements, and elements of a change control system. The document describes the steps in a typical change control process, including classifying, assessing, planning, implementing, evaluating, and closing changes. It provides examples of major and minor changes and discusses the documentation and challenges of maintaining an effective change control system. Maintaining proper communication, turnaround times, documentation, and training are important for managing changes in a controlled manner.
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
This document provides an overview of CGMP (Current Good Manufacturing Practice) and industrial management. It discusses key aspects of CGMP such as plant layout, services, equipment, production organization, materials management, handling and transportation, inventory management, production planning and control, sales forecasting, budgeting, quality management, and industrial relationships. The objectives of CGMP are to ensure product quality and consistency in manufacturing. Key elements outlined include facilities and equipment requirements, quality control of materials, production systems, and regulatory compliance.
The document provides a summary of Joseph E. Mack Jr.'s qualifications for a Quality Assurance position. He has over 10 years of experience in Quality Assurance and Quality Control, including being a Certified Quality Auditor. He has extensive knowledge of cGMP regulations and experience auditing both internal and external processes. Currently he is the GMP QA Manager at Cambridge Isotope Laboratories where he oversees the Quality System and ensures compliance.
The document discusses validation in the pharmaceutical industry. It defines validation according to WHO, US FDA, and ICH and explains the need, importance, scope and types of validation. The main types discussed are process validation, cleaning validation, equipment validation, and validation of analytical methods. Documentation for validation includes the validation master plan, validation protocols and reports, and standard operating procedures. Qualification is also discussed as being related to but distinct from validation, involving design, installation, operational and performance qualification of equipment.
This document discusses pilot plant scale-up techniques for pharmaceutical manufacturing. It defines a pilot plant and scale-up process. The key steps in scale-up involve conducting laboratory and smaller pilot studies, designing and constructing a pilot plant, evaluating results to make corrections, and deciding whether to proceed to full-scale production. General considerations for a pilot plant include personnel requirements, equipment, production rates, process evaluation, and ensuring product stability and uniformity. GMP must also be followed in areas like process validation and documentation.
This document discusses pilot plant design, operation, and scale up considerations for pharmaceutical manufacturing processes. It provides an overview of the need for pilot plants and scale up to transfer processes from the laboratory to production scale. Key sections include descriptions of pilot plant attributes, operational aspects like validation and training, scale up principles of similarity, and development milestones from formulation through clinical and commercial production. Process parameters that should be evaluated at various stages like mixing, drying, milling and compression are also outlined.
Terry Nicholas is a quality assurance professional with over 30 years of experience in manufacturing industries including aerospace, precision engineering, food packaging, automotive components, and more. He has extensive experience maintaining and achieving accreditations like ISO 9000, AS9100, and BRC/IOP. His background includes roles as quality manager, quality engineer, root cause analysis, audit lead, and training. He has worked to improve quality systems and processes for companies in aerospace, banking/cards, injection molding, printing, and other sectors.
Jose Falcon has over 15 years of experience in manufacturing and quality assurance roles in the medical device and pharmaceutical industries. He has a strong background in quality system regulations and statistical process control. Currently he is a Senior Manufacturing Supervisor at St. Jude Medical, where he has improved productivity by 15% and reduced excess inventory levels. Previously he held supervisory roles at Cardinal Health and Ethicon, where he implemented lean initiatives and electronic systems to improve efficiency.
This document is a resume for Mayra I. Casiano summarizing her experience in the medical device and pharmaceutical industries. She has over 20 years of experience in manufacturing, process/packaging, technical services, and validation. Some of her responsibilities have included leading manufacturing operations, implementing technology transfers, ensuring regulatory compliance, and authoring standard operating procedures. She is proficient in validation protocols for facilities, equipment, and processes.
Lisa Burdick has over 15 years of experience in quality and regulatory roles within ISO 13485 and FDA regulated environments. She has extensive experience with quality documentation, lot release, sterilization processes, auditing, and calibration systems. Currently she works as a Senior Quality Systems Specialist at Valeritas, where she manages lot release, sterilization processes, documentation systems, auditing, and corrective and preventative action programs.
Documentation relating to product development,sop's,cleaning methods,quality ...swrk
COMPLAINT HANDLING IN PHARMACEUTICAL COMPANIES,PRODUCT RECALL,RETENTION RECORDS, DISTRIBUTION RECORDS.prepared by s.susena,m.pharmacy pharmaceutical analysis&QA,ssj college of pharmacy
This document provides guidelines for process validation of pharmaceutical dosage forms issued by the Saudi Food and Drug Authority (SFDA). It outlines three stages of validation: process design, process qualification, and continued process verification. The guidelines describe the principles and approaches for validation, including qualification, protocols, reports, and management of changes. Process validation aims to ensure manufacturing processes are capable of consistently producing products of the required quality.
As the worldwide business climate has grown increasingly complex – due to globalization, consolidation, governmental regulation, labour issues, financial pressures, supply chain management and security concerns – the purview of “operations management” has expanded.
Operations management is the business function that plans, organizes coordinates and controls the resources needed to produce a company’s goods and services.
It is mainly concerned with managing the process that converts inputs into outputs.
It closely interacts with the accounting, finance and human resource management function in an organization.
Pharmacy is a highly competitive industry, and companies are experiencing financial pressures more than ever before.
Hence OPERATIONS MANAGEMENT IS THE CENTRAL CORE FUNCTION OF EVERY COMPANY
M. Srinivasan is an experienced Operations Manager with over 18 years of experience in pharmaceutical manufacturing. He has a strong background in production planning and quality assurance. Srinivasan is looking for new opportunities to utilize his skills in operations management, process improvement, quality audits, and machinery maintenance. He has worked for several major pharmaceutical companies and has experience managing facilities, projects, and over 400 employees.
El documento habla sobre la importancia de la privacidad y la seguridad en línea. Explica que los usuarios deben tomar medidas para proteger su información personal en Internet, como usar contraseñas seguras y actualizadas, y estar atentos al phishing.
Este documento discute diferentes perspectivas sobre el arte y la identidad cultural de grupos marginados. Primero, analiza exposiciones de arte occidentales de los años 80 y 90 que intentaron mostrar el arte de culturas no occidentales pero lo hicieron de una manera etnocéntrica que reforzó estereotipos. Luego, describe cómo surgieron discursos descolonizadores que cuestionaron esta visión y promovieron espacios como las Bienales periféricas para dar voz a estas culturas. También examina el arte de las minorías en EE.UU. y el
El documento describe las causas y el diagnóstico de la discapacidad visual y auditiva en niños. Explica que las causas de la sordera incluyen enfermedades infecciosas, traumas, problemas de desarrollo fetal, causas metabólicas y causas tóxicas. El diagnóstico de la discapacidad visual involucra pruebas como el test de Snellen, la prueba de campo visual y la tonometría para medir la agudeza visual, visión periférica y presión ocular. El documento también enumera posibles
Egypt is a transcontinental country located in both Africa and Asia. It has a hot desert climate and borders Libya, Gaza, Israel, and Sudan. Egypt has many historical and cultural sites to visit along the Nile River Valley including the pyramids of Giza and temples in Luxor. The culture has been influenced by ancient Egyptian, Greek, Christian, and Islamic periods. Popular local foods include kushari, ful medames, and mulukhia. A 10-day itinerary visits Cairo, Aswan, Luxor, Hurghada along the Nile River and includes cruise and sightseeing.
This document summarizes an experimental study on the behavior of built-up steel-concrete composite columns with angle sections under axial and eccentric loading. The study included testing composite columns with conventional concrete, fiber reinforced concrete, and additional reinforcement. Load-deflection behavior, moment-curvature relationships, and load-moment interaction diagrams are presented and discussed. Key findings include the concrete carrying most of the load and failing in compression before steel yields, and fiber reinforced and reinforced specimens exhibiting higher load capacities than conventional concrete specimens.
Este documento habla sobre la deficiencia visual. Define la ceguera y otros tipos de deficiencia visual como la ambliopía. Explica las causas de la deficiencia visual como enfermedades hereditarias, congénitas o accidentales. También clasifica las deficiencias visuales según su aparición y grado. Describe los posibles retrasos en el desarrollo de personas con deficiencia visual y la necesidad de una evaluación funcional y educación adecuada.
Este documento trata sobre la inclusión educativa. Define conceptos clave como discapacidad, inclusión, integración y diversidad. Explica que todos los estudiantes, independientemente de sus diferencias, merecen igualdad de derechos, respeto y apoyo mutuo. También contrasta los modelos tradicionales y de inclusión educativa, señalando que este último se enfoca en el desarrollo integral del estudiante y la equidad. Por último, enfatiza la importancia de trabajar en equipo, respetar las opiniones de todos y comunicarse a
Gaurav Kumar is seeking a position that offers new challenges and responsibilities. He has 5.6 years of experience in production operations, process enhancement, and people management. Currently he works as a Production Executive at Hindustan Unilever Limited, where he is responsible for production targets, safety, quality, and implementing a continuous improvement culture. He holds a B.Tech in Chemical Engineering and has experience working at Henkel and Hindustan Unilever Limited.
Rex Serrano Morales has over 25 years of experience in quality assurance, regulatory compliance, and validation for pharmaceutical and chemical manufacturing. He has worked for major companies like Amgen, Merck, and Procter & Gamble in roles managing quality, compliance, validations, audits, and regulatory submissions. He is a licensed chemist with expertise in GMP standards, change control, computer validation, investigations, and regulatory inspections.
The document provides a summary of Nikhil Mahajan's qualifications and experience seeking a role in quality management. It outlines his past work experience spanning over 15 years in quality assurance and systems roles at various automotive companies. It also lists his responsibilities in areas like new product development, supplier quality, quality systems, audits, and projects. His academic credentials include an MBA and BTech in Mechanical Engineering. Contact details and a profile outline are also included.
Control production process and production facilities of SLES and LABSAWaleed Ahmed
The document outlines the responsibilities of a production manager including overseeing production processes and facilities, monitoring equipment parameters, ensuring production targets are met, applying quality standards, coordinating with maintenance and quality teams, utilizing process improvement techniques, ensuring safety compliance, training staff, and reporting on production activities and issues. Responsibilities also include overseeing analytical testing of materials and products to ensure quality standards are met.
Albert Brantley Jr. has over 30 years of experience in quality assurance and production roles in the pharmaceutical and chemical industries. His experience includes writing validation protocols and standard operating procedures, performing audits, developing quality systems, and managing production. He currently works as a Quality Engineer for Paxico LLC where he leads validation and compliance activities.
This document contains the résumé of Ahmed Abdel Moneim Mohamed Sadek. It outlines his professional experience as the Supply and Demand Manager at Novartis Pharma Egypt since 2001, as well as his education credentials which include an MBA and B.Sc. in Pharmaceutical Sciences. It also lists his areas of expertise in supply chain management, manufacturing, quality assurance, and leadership skills.
I'm Looking forward to a challenging work opportunity in your esteemed organization, where my experiences can be utilized and enriched and I can share in achieving the organization mission and strategic goals.
certificates link:
https://www.slideshare.net/AhmedShehta12/ss-250260913
The summary provides information on Kristine Kowalski's background and experience in quality assurance, validation, and regulatory affairs. She has over 13 years of experience in these fields, including serving as the Validation Manager at Cody Laboratories for over 4 years. She has extensive experience leading validation projects, writing documentation, ensuring compliance, and mentoring others. Her skills include validation, cleaning validation, computer system validation, and regulatory submissions.
Arvind Mahuli is an experienced EHS professional with over 22 years of experience in quality audits, safety, health, and environmental systems. He currently works as the EHS Head and Management Representative for ISO 14001 and 18001. He has extensive experience implementing EHS systems, conducting internal and external audits, and providing training. He aims to secure a position that utilizes his skills in EHS, auditing, problem-solving, and systems implementation.
Amit Arun Mane is a chemical engineer with over 13 years of experience in quality control, operations and maintenance. He is seeking a senior level position in these areas. He has a proven track record of improving process efficiency and ensuring quality compliance. Mane has worked in various roles for companies like Indian Oil Skytanking Limited and Universal Forces Industries, focusing on areas such as quality assurance, production planning, and operations and maintenance. He is adept at resource planning, team building and issue resolution.
Deepu Gupta is an Assistant Manager at Samtel Avionics Limited with over 9 years of experience in production, quality assurance, and quality control. He has a B.Tech in Mechanical Engineering and is seeking a challenging position with opportunities for growth. His experience includes production planning, module testing and validation, supplier quality management, and ensuring compliance with quality standards.
Ejaz Shahid has over 30 years of experience in pharmaceutical quality assurance and quality control. He holds a Master's degree in Pharmacy and has worked in senior QA roles for several pharmaceutical companies in Saudi Arabia, Pakistan, and the UAE. Currently he is the Senior Manager of Quality Assurance at Global Pharma in Dubai, where he oversees QA, QC, validation, auditing and ensures compliance with cGMP regulations.
Sivalingam is a seasoned professional with nearly 10 years of experience in production operations, process enhancement, and maintenance. He is currently working as a P&P Engineer at Falcon Technologies International in Ras Al Khaimah, UAE. Some of his key responsibilities include manpower allocation, productivity improvement, meeting production commitments, and multi-skilling operators. Previously he has experience optimizing manufacturing systems to reduce costs, deployment of resources, and ensure quality compliance. He is proficient in various tools including 5S, Kaizen, 7 QC tools, TPM, Lean Manufacturing and Six Sigma methodology.
Krishnakumar Agrawal has over 18 years of experience in operations management, quality control, and production planning. He is currently seeking a senior role managing manufacturing operations or process improvement.
He has a background in mechanical engineering and quality management. Most recently, he worked as the Manager of Quality and Material Review at Genus Electrotech, where he implemented quality initiatives like six sigma projects and ISO audits.
Krishnakumar has expertise in quality systems, production planning, maintenance, and vendor management. He aims to institutionalize best practices and help organizations achieve their strategic objectives through process improvement and team-based problem solving.
This document contains a summary of an individual's professional experience, qualifications, and expertise. It includes over 24 years of experience in manufacturing, quality, maintenance, sourcing, TPM, Six Sigma, EHS and HR. They have worked for several multinational companies in leadership roles with a focus on production, quality, engineering, procurement, safety, health and environment. They possess strong problem solving, analytical, and organizational skills and have expertise in areas like production planning, quality control, process improvement, cost reduction, and statutory compliance.
This document provides a summary of Ashwini Kumathekar's work experience and education. It details her roles in planning, scheduling, and production management for pharmaceutical companies like Cipla Ltd and Reliance Life Sciences from 2007 to the present. Previous experience includes quality control analysis and handling internal meetings and documentation. Education includes an MBA in International Business Management and a BSC in Biotechnology. Skills listed are proficiency in Microsoft Office and SAP modules.
Dhaneshkumar G. Desai is a chemical processing expert with over 26 years of experience in API and fine chemical manufacturing. He has a proven track record of leading production teams, implementing new processes, ensuring compliance with cGMP standards, and improving productivity through cost reduction and yield enhancement. Currently he is seeking a managerial position in API manufacturing with a reputable organization.
Sudeep Killedar is seeking a career enriching role in business development with a focus on the pharmaceutical industry, leveraging his nearly 9 years of experience in production, process enhancement, packaging, and research documentation for well-known pharmaceutical organizations. He has skills in enhancing production operations, optimizing resources, and ensuring compliance with quality standards and regulatory guidelines. The document provides details on his educational background and work experience in various roles with increasing responsibility in the pharmaceutical industry.
This document provides a summary of Rengaraj Narayanaswamy's work experience and qualifications. He has over 7 years of experience in validation, quality assurance, and commissioning activities for biopharmaceutical and pharmaceutical industries. Currently, he works as a Senior Executive of Validation at Mylan Laboratories, where he leads validation activities such as preparing validation protocols, executing qualifications, and handling quality management systems. He has comprehensive experience in process engineering, project management, and ensuring compliance with regulatory standards like cGMP.
Mohamed Salah Elsayd is seeking a managerial position in quality assurance. He has over 9 years of experience in quality control, quality assurance, auditing quality management systems, and process control. He holds a B.Sc. in Chemistry and is trained and qualified in ISO 9001, quality auditing, and quality tools. Currently he is a Quality Assurance Leader at Procter & Gamble, where he is responsible for quality policies, strategies, audits, and leading teams to achieve targets and improve quality. He has experience leading quality improvement workshops and implementing quality assurance programs.
1. HARPREET SINGH
Phone: +91-172-4052732; Mobile: +91-9888011171
Email: harpreetsingh1314@gmail.com
OBJECTIVE
Seeking a position to utilize my skills and abilities in the pharma industry
that offers Professional growth while being resourceful, innovative and
flexible.
EXECUTIVE SUMMARY
Seasoned and dynamic Management Executive with a gratifying career
span of more than 19 years predominantly in the areas Equipment And
Utility and System Validation (DF), Production (API), Training and
Development (LMS), cGMP & Regulatory Compliance, Documentation,
General Administration etc.
Significant experience of modern concepts of Quality & Value
Engineering, ensuring quality of product by using tools of ICH in Validation
(Equipment & Utility & System Qualification), etc. Facilitate preparation of
Validation/Qualification Protocols and Reports and review activities of
qualification related to Equipments, and utilities/System.
Hands on knowledge of US FDA, MHRA(UK), EU, ANVIZA(Brazil),
PMDA(Japan),TGA(Australia),WHO GMP, regulations, successfully
conducted self-auditing of manufacturing / production areas, to ensure
GMP compliance, adequate experience in handling & reviewing
deviations, Investigations, change controls, OOS and OOTs, SOPs , VMP
(Validation Master Plan) and validation protocols and reports, OOS and
OOTs
Consummate professional with demonstrated capability in ensuring
judicious utilization and allocation of available resources - materials,
machines and manpower, to achieve organizational targets while creating
a healthy and friendly work environment and thereby enhancing
operational efficiency.
Computer savvy with hands on knowledge of SAP, MS-Office, Trackwise
(For change controls), Documentum Compliance Management (DCM)
(For SOP’s & STP’s), Learning Management System (LMS) (For on
line trainings).
2. CAREER MILESTONES
Successful association with Sun Pharmaceutical Industries Limited
(erstwhile Ranbaxy Laboratories Limited) for more than 19 years.
Executed diverse responsibilities in various departments including,
Validation (DF equipments and utilities and systems), Production
(API), Quality Assurance, Training and Development through LMS,
Regulatory Compliance Audits including US
FDA,MHRA,EU,ANVIZA,PMDA,TGA, WHO GMP and Safety Initiatives
and Documentation.
Appreciated for outstanding performance and rewarded Excellence
Award in Ranbaxy Laboratories for improving the quality, cost savings,
inventory liquidation and reducing cycle time in 2009.
Conducted Self-Auditing of Manufacturing / Production Areas, to ensure
GMP compliance.
Handled and reviewed deviations, investigations, change controls,
VMP (Validation Master Plan), validation protocols, validation
reports, SOP, OOS and OOTs.
PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS
Employed as production chemist in Feb.1997 and now as senior executive
in Sun Pharmaceutical Industries Limited (erstwhile Ranbaxy Laboratories
Limited). During this period of job I had worked in plants of sterile (Bulk
API), non sterile (Bulk API) and dosage form(OSD).
In Dosage Form (OSD) - (2012-Till date)
I am currently handling validation activity related to all equipment and
utilities (HVAC System, Water System, Compressed Air System, Nitrogen
Air System).And performing various activities related to validation such as
URS (User Requirement Specification)
DQ (Design Qualification)
RA (Risk Assessment)
cGXP IA (Impact Assessment)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
FQ (Facility Qualification)
TM (Temperature Mapping)
Successfully completed the validation activity of two projects –New
Microbiology lab and New Solvent Warehouse establishments.
Preparation of URS for the equipment / System.
Review of design specification offered by vendor and compares it with
URS and preparing DQ.
Preparation of RA for the equipment / System
3. Preparation of GXP Impact Assessment for the equipment and system to
categories as Direct, Indirect, No Impact Category.
Preparation and Approval and Execution of validation protocol and
summary report of IQ, OQ, PQ.
Preparation and Approval and Execution of validation protocol and
summary report of FQ and TM.
Performing Periodic Performance Verification (PPV) of the equipments
and system as per their schedule timing to have equipment and system in
validated state of control.
Preparing PPV calendar and PPV report matrix on yearly basis.
To coordinate and interact with vendor, engineering department, user
department and project team for the timely completion of the validation
activities and resolve of technical issues.
To ensure compliance of cGMP and GDP.
Preparation of Master Validation Plan for the site
Equipment validated-HVAC system, RLAF(Dispensing & Sampling
Booth), LAF, Water System, Compressed Air System, Area Qualification,
Capsule Filling Machine, Tablet Compression Machine, Cold Room, Sifter,
Multimill, Inverted Mode Air Jet Bottle Cleaning Machine, Domino
Printer(Ink Jet Printer), Blister Sealing Machine, Strip Sealing Machine,
Rapid Mixer Granulator, FBD, Coating Machine, Liquid Filling Machine,
Roll Compactor, Dedusting Tunnel, Sticker Labelling Machine,
Checkweigher, Dose Cup Capping Machine, Homogenizer/Colloidal Mill,
Tablet Printing Machine, Induction Sealing Machine, Filter Cleaning
Station and many more…
I am also looking after and imparting the training through Learning
Management System (LMS) to the users of the plant. Training related to
all kind of SOP (Standard Operating Procedure) and cGMP training
I am LTC for LMS at site, learning software supported by M/s SumTotal.
Collate all departments Master Training Need Matrix (MTNM) for
preparing location MTNM.
Configuring and Uploading training material and task in LMS.
Auditing and compliance of training at site.
Creation of Job Roles in LMS as per MTNM.
Creating learning activities/curriculum in the system as new activity or for
revised version and categorized under SUN specific, Regulatory,
Developmental and Activity based SOP’s.
Assigning curriculum to Job Role as per MTNM.
Associating Job Role to the users as per MTNM.
Training records and available in the system at all times on real time
basis.
Monitoring Training Compliance – User Wise / Activity Wise.
Various reports are generated such as :-
1. Completion and Compliance Reports
a) Learning activity SOP allocation to departments
4. b) Department wise Matrix Completion Reports
c) Department wise Training allocation and completion (Graph) with
detail report.
d) SOP wise department employee wise training completion.
e) Job Role wise training compliance.
f) Location wise training completed during a period
g) Location wise Manday’s summary during a period.
h) Location wise Manday’s detail report during a period.
i) Compliance reports.
2. LMS reports
a) List of Job Roles
b) List of Department / Functions
c) List of learning Activities and Topics
d) Employees Master
e) Trainer Qualification Reports
3. MTNM Reports
4. Impact Assessment Reports
5. List of Unsuccessful Attempts / Failure Attempts and many more….
I have actively participated in getting the ISO 14001 and OSHAS for the
site.
In Non Sterile Production (API Bulk) - (2000-2011)
I have involved in manufacturing of cefuroxime axetil amorphous chemical
route and spray dried route. I have also handled manufacturing of
cefditoren Pivoxil Spray Dried Premix.
I had worked in plant setup of spray drying at project stage in our
organization in the year 2005
Review of batch production records (BPR) and in process test.
Involved in managing operations, documentation, quality assurance,
and planning activities along with a team of 20 members.
Manage the production planning and control activities, setting up
production targets and handling plant operations to ensure timely
completion of production targets within the defined time and cost
parameters.
Played an important role in effective resource planning and utilization,
reducing waste for enhancing productivity and profitability.
Involved in maintaining records as per GMP requirements, and self /
internal auditing of manufacturing / production areas to ensure GMP
compliance and quality commitments.
Ensure adherence to various SOPs, STP & SCPs
Prepare, Review & implement MPR.
5. Follow up mechanism to handle and successfully close a non-
conformance.
Initiation of Change Control and their closure
Participated in failure investigation (Out of specification). Conducted root
cause analysis of the problem and identification of major root causes and
their remedies. Handled & reviewed deviations, change controls, OOS &
OOT.
Qualification of HVAC (Heating ventilation and air conditioning system).
Validation of production systems like drying validation, blending
validation.
Responsible for installation Qualification, Operational, Qualification,
Performance Qualification of systems.
Ensuring that the Quality Management System is maintained in
accordance with ICH Guideline.
Drive the continuous improvements in operational qualities, setting up
controls, reviews, and implementation of corrective actions.
People Engagements & effectives on quantity improvements projects.
In Sterile Production (API Bulk) - (1997-1999)
I have involved in manufacturing of sterile ceftriaxone sodium and sterile
cefatoxime, acid.
Autoclave qualified with respect to IQ, OQ, PQ and know how to operate
the equipment, used for sterilizing filter cartridges(used for sterile
filtration),Rubber bungs, garments.
Dry Heat Sterilizer (DHS) qualified with respect to IQ, OQ,PQ and know
how to operate the equipment. Use for sterilizing Aluminium containers,
Caps, foil and sampler etc.
WFI (Water for injection) qualified.
Pure steam generator qualified.
Filter integrity testing by Bubble point method by Millipore equipment.
Versaport-10 particle counter operated used for counting particle count on
monthly basis as per AHU classification class A, B, C, D.
HVAC system of sterile area qualified.
Hanging Laminar Air Flow (LAF) for class A qualified.
Preparation and approval of validation Protocol and Reports.
Review of batch production records and in process test.
6. PROJECTS HANDLED
1. New Microbiology Lab made operational at OSD site
Following activities carried out to related with the validation/qualification
activities :-
Made Use Requirement Specification (URS) of the Heating Ventilation Air
Conditioning (HVAC) to be procured for the project.
Installation Qualification (IQ) of the HVAC system performed.
Operational Qualification (OQ) of the HVAC system performed.
Performance Qualification (PQ) of the HVAC system performed, covering
parameters such as:-
Air Velocity and Air Changes Per Hour
Filter Integrity Test
Differential Pressure Monitoring Test
Non-Viable Particle Count Test
Recovery of Non-Viable Particle Count Test
Air Flow Visualization Test
Temperature & Relative Humidity Monitoring Test
Recovery of Temperature & Relative Humidity & Differential Pressure Test
Viable Count Test ( Microbiological Monitoring Test)
Made User Requirement Specification (URS) for the Facility.
Performed Facility Qualification/Area Qualification of the facility covering
parameters such as:-
Rooms Dimensions
Material & Personnel flow
Floor-MOC, Surface finish
Doors-MOC, Size, Interlock
Coving-MOC, Surface finish
Ceiling-MOC, Surface finish
Vision Panel-MOC, Size
Drains-Air Break, Cover
Walls-MOC, Paint colour, Paint Type, Surface finish
Steam, Pure Steam, Compressed Air, Industrial Gasses
Electrical & Associated-Number of lights, Illumination level, single/three
phase etc
HVAC-Supply & Return grill number, ACPH, Temperature, Relative
Humidity, Differential Pressure, HEPA filter leak test, Particle count,
Microbiological Monitoring
Water- Potable, Purified, Water for injection
2. New Solvent Warehouse made operational at OSD site
In similar way as above another Project of solvent Warehouse was
handled.
7. 3. New Spray Dryer Plant- From ALFA LAVAL made operational at API
Bulk site
I have handled the project of plant set up of spray dryer
Following activities carried out during the project:-
Installation Qualification (IQ) of the equipment performed.
Operational Qualification (OQ) of the equipment performed.
Performance Qualification (PQ) of the equipment performed, covering
parameters such as:-
Taken trails with product Cefuroxime Axetil at different Inlet & Outlet
Temperature setting of the spray Dryer .
At various RPM of the Supply blower and the Exhaust blower for the
optimisation of the speed.
To check & verify the RPM of the Atomiser
To check the Amorphous nature of the product, it should not be in
crystalline nature
Spray Drying is performed to convert the crystalline form of the product
into Amorphous form.
SPECIALZED TRAINING
Gone through extensive 400hrs of training at karnataka antibiotics and
pharmaceuticals limited Bangalore in following area – Dry powder
parentrals and non parentrals and small volume parentrals and
quality control and store management. Training on fire fighting with
advanced fire fighting techniques.
ACADEMIC AND PROFESSIONAL CREDENTIALS
Bachelor of Pharmacy (B’PHARMA) from Bangalore University.
Audits Handled
US-FDA – 1998, 2000, 2003, 2007, 2008
TGA – Australia – 2000, 2004
Germany Audits – 2005, 2007
WHO – GMP Audits – 1999, 2003, 2007, 2008, 2014
PERSONAL DETAILS
Address : H.No.1314, Sector-68, Mohali (Punjab), Pin-160062, India
Date of Birth: 20th April 1972
Marital Status: Married
Blood Group: O-ve