PharmTech is a quality and life cycle management firm established in 1995 specializing in FDA compliance for pharmaceutical, medical device, and biotech industries. They provide a range of core services including workflow management, strategic solutions, CAPA validation, and technology integration. Their team has extensive experience in areas like methods and process validation, auditing, supplier assessment, clinical operations, and cGMP compliance. PharmTech offers a cost-effective, turnkey approach and prides itself on its manufacturing experience, established network, and track record of delivering ROI for clients.
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Doc...Anita Anzo
Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT
Duration : 60 Minutes
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
- Marlabs is an award-winning global provider of IT services and BPO services founded in 1996 with over 1,500 professionals worldwide.
- They have experienced robust 847% growth in revenue over the last 5 years and have received numerous awards and accolades for their performance.
- Marlabs provides a range of services including software development, business intelligence solutions, clinical research management, and more to clients across various industries globally.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
The document discusses preparing for FDA inspections of computer systems and IT infrastructure. It outlines developing an IT compliance plan to ensure control of data, applications, infrastructure, procedures, suppliers, documented evidence, and personnel. The plan should identify any gaps and risks. Organizations should qualify IT systems, validate computerized systems, ensure data integrity, and monitor outsourced processes. Training personnel and periodically reviewing the quality management system are also important for inspection readiness. The speaker emphasizes developing evidence of implementing regulatory requirements to demonstrate control to inspectors.
V2 Bio-Consulting, Inc. is a consultancy providing expertise in quality assurance, operations, engineering, and project management to biopharma, chemical, and industrial clients. With experience working in management roles at life sciences companies, V2's team of consultants partners with clients to augment and optimize operational and project performance through services like quality system implementation, auditing, validation, and manufacturing support. Headquartered in the San Francisco Bay Area, V2 seeks to address clients' specialized needs from strategic planning through tactical management on projects worldwide.
Nitor Infotech provides computer system validation (CSV) services to ensure regulatory compliance and prevent issues. Their CSV approach includes validation planning, design verification, installation qualification, operational qualification, performance qualification, and code reviews. They offer end-to-end CSV as well as gap analyses, service consolidations, and validation of spreadsheets, enterprise applications, and PLC systems. CSV reduces risks and costs by documenting requirements for regulators and ensuring quality, compliance, and patient safety.
This document provides an overview and summary of ISQC 1 for small and medium accounting practices. It discusses the objective of ISQC 1, which is for firms and personnel to comply with professional standards and regulations and issue appropriate reports. It outlines the key elements that must be included in a system of quality control, including leadership responsibilities, ethical requirements, client acceptance, human resources, engagement performance, and monitoring. It emphasizes that the nature and extent of policies and procedures will depend on the size and characteristics of the firm. It also notes that the firm must document its quality control system and policies and communicate them to personnel.
PharmTech is a quality and life cycle management firm established in 1995 specializing in FDA compliance for pharmaceutical, medical device, and biotech industries. They provide a range of core services including workflow management, strategic solutions, CAPA validation, and technology integration. Their team has extensive experience in areas like methods and process validation, auditing, supplier assessment, clinical operations, and cGMP compliance. PharmTech offers a cost-effective, turnkey approach and prides itself on its manufacturing experience, established network, and track record of delivering ROI for clients.
21 CFR Part 820 - Quality System Regulation - Applying Principles of Lean Doc...Anita Anzo
Scheduled On : Wednesday, July 24, 2013 at 1:00 PM EDT
Duration : 60 Minutes
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820, yet is based on solid principles and proven practices.
- Marlabs is an award-winning global provider of IT services and BPO services founded in 1996 with over 1,500 professionals worldwide.
- They have experienced robust 847% growth in revenue over the last 5 years and have received numerous awards and accolades for their performance.
- Marlabs provides a range of services including software development, business intelligence solutions, clinical research management, and more to clients across various industries globally.
This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S . FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications"
2016-06-08 FDA Inspection Readiness - Mikael Ydemikaelyde
The document discusses preparing for FDA inspections of computer systems and IT infrastructure. It outlines developing an IT compliance plan to ensure control of data, applications, infrastructure, procedures, suppliers, documented evidence, and personnel. The plan should identify any gaps and risks. Organizations should qualify IT systems, validate computerized systems, ensure data integrity, and monitor outsourced processes. Training personnel and periodically reviewing the quality management system are also important for inspection readiness. The speaker emphasizes developing evidence of implementing regulatory requirements to demonstrate control to inspectors.
V2 Bio-Consulting, Inc. is a consultancy providing expertise in quality assurance, operations, engineering, and project management to biopharma, chemical, and industrial clients. With experience working in management roles at life sciences companies, V2's team of consultants partners with clients to augment and optimize operational and project performance through services like quality system implementation, auditing, validation, and manufacturing support. Headquartered in the San Francisco Bay Area, V2 seeks to address clients' specialized needs from strategic planning through tactical management on projects worldwide.
Nitor Infotech provides computer system validation (CSV) services to ensure regulatory compliance and prevent issues. Their CSV approach includes validation planning, design verification, installation qualification, operational qualification, performance qualification, and code reviews. They offer end-to-end CSV as well as gap analyses, service consolidations, and validation of spreadsheets, enterprise applications, and PLC systems. CSV reduces risks and costs by documenting requirements for regulators and ensuring quality, compliance, and patient safety.
This document provides an overview and summary of ISQC 1 for small and medium accounting practices. It discusses the objective of ISQC 1, which is for firms and personnel to comply with professional standards and regulations and issue appropriate reports. It outlines the key elements that must be included in a system of quality control, including leadership responsibilities, ethical requirements, client acceptance, human resources, engagement performance, and monitoring. It emphasizes that the nature and extent of policies and procedures will depend on the size and characteristics of the firm. It also notes that the firm must document its quality control system and policies and communicate them to personnel.
9 regulatory compliance and validation for liWebseology
This document provides an overview of challenges facing the life sciences industry and discusses validation requirements for computer systems. It contains the following information:
- The pharmaceutical, medical device, and biotechnology industries face issues like loss of revenue from generics, high costs to develop new drugs, and new regulations. Computer validation is important in these regulated industries.
- FDA validation requirements are defined as demonstrating through documented evidence that a system consistently operates according to predetermined specifications. Validation ensures quality, objectivity, and that developers cannot check their own work.
- A validation toolkit is presented that follows GAMP 5 guidelines and parallels an established validation methodology. It contains templates, scripts, and tools to help customers efficiently validate computer systems in a
A GLOBAL LIFE SCIENCES COMPANY IMPLEMENTS ADAPTIVEGRC SOLUTION SUITE FOR VARIOUS GRC SERVICES
The customer is a global Life Sciences company operating in over 50 international markets. With $5bn annual turnover it has more than 4000 employees.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Parthiv Shah is a regulatory and compliance professional with over 10 years of experience in the medical device industry. He has successfully obtained 11 FDA 510(k) clearances in the last 4 years. He has also registered medical devices in countries across Europe, Asia, Australia, Canada, and others. Additionally, Shah has experience managing recalls and regulatory audits, submitting five MDR reports to the FDA and closing two recalls. Currently, he works as a Senior Regulatory Affairs Specialist at Vital Images, where he has led projects involving 510(k) submissions, international registrations, recalls, and regulatory audits.
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
The document introduces Quality Vision, an integrated quality and safety management software solution. It consists of several modules that can be used together or separately, including quality and safety planning, control plans, complaint management, and quality system management. The software provides features like pre-requisite program management, integrated testing and sampling, and multi-level access controls. It is designed to help companies comply with standards, demonstrate quality controls, and integrate with other business systems.
Scott Buchheit is seeking a regulatory specialist position in the Minneapolis-St. Paul area. He has extensive experience in medical device regulatory affairs and FDA regulated environments, including authoring technical file documents for Europe and ensuring compliance of product literature. Buchheit has a Master's in Regulatory Affairs and Services from St. Cloud State University expected in December 2015, as well as certifications in quality management. He aims to apply his regulatory strategies and submissions experience, including for 510(k)s, PMAs, and IDEs, to a new position.
This document discusses computer system validation and process validation. It defines process validation as establishing evidence through all stages of production to consistently deliver quality products according to regulations. The FDA defines process validation as providing high assurance a process consistently meets specifications. Key concepts include three validation stages: process design, process qualification, and continued verification. There are four types of validation: prospective, retrospective, concurrent, and revalidation when changes are made.
Experience guide to or implementation and compliance 2015Edifecs Inc
Ready to kick-off a compliance project? Don’t miss this webinar; leverage our experience to accelerate your compliance programs. Understand the certification options. Gain insight to assist your organization maintain compliance after project completion. Understand how certification and partner communication can protect your organization.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
The documentation system is key to cGMP and establishes formats and traceability. Documents must be maintained in a controlled manner and provide records for compliance. Written procedures exist for all production, quality control, packaging and labeling processes. Documentation provides organized information that serves as proof and answers for regulators: what is being done, why, if procedures are being followed, and if things are under control. The documentation system integrates tasks like generation, review, approval, distribution and retention/destruction of documents.
Paul E Schafer is a regulatory affairs specialist with over 5 years of experience in an ISO 13485 medical device manufacturing facility. He is looking to leverage his knowledge and experience in a role as a regulatory affairs specialist. His experience includes coordinating international device registration, managing complaint information, and facilitating regulatory support. He also has experience in quality roles such as document review, quality training management, and filling in as document control.
GTS Systems quality solutions for labs are both technology-oriented and standards-driven reliable, accurate, and smart results that aid in lab diagnosis and data management.
Independent Intelligent Quality Control Solutions Adopted By GTS Systems For Smartening, Modernize, and Highly Visualized Your Lab Data.
A dedicated audit management program helps streamline the audit preparation process and implements board directives by simplifying and systematically organizing the workflow. It allows companies to prove compliance with industry standards through internal and external audits required by their regulations. The program offers separate internal and external audit modules that use role-based security and provide a single source of control documentation for easy access.
Automated System Validation in FloridaAndre Butler
The document introduces the ADB Automation and Validation Group which provides expertise in fields like automated system validation, equipment validation, process validation, software validation, and FDA validation compliance. The group helps ensure manufacturing processes are flawless and products meet quality standards. It provides validation services for customers' specific automation and validation needs.
This is our framework to manage organizational operations and serve our clients. This includes various tools, architecture, models, documents, quality programs and many more steps that is beyond the enterprise limits.
The document describes a global solution for managing documents and processes for pharmaceutical companies called Stratesys QA-CAPA. It provides a corrective and preventive action (CAPA) management system that simplifies the identification, management, and closure of customer claims and non-conformities. The solution brings together best practices and technology to automate and monitor these critical business processes. It aims to significantly reduce customer complaints, minimize financial risks of non-compliance, and maintain compliance with quality and market regulations.
Best Enterprise Quality Management SoftwareQualityze Inc
Qualityze EQMS Suite is a comprehensive solution that enables organizations to proactively manage their quality, safety, and compliance issues while fostering a culture of continuous improvement. It is a set of ten powerful modules that helps to build a closed-loop quality management system. Each module comes with unique functionalities and can seamlessly integrate with the existing business applications to provide more control and confidence in managing data. It also enables you to make data-driven decisions to reduce overhead expenses.
Qualityze is an easy-to-customize, intuitive, and powerful quality management solution that can scale with your business’ ever-growing and changing needs. It is driven on a cloud platform, so you can leverage more flexibility and accessibility to manage business processes globally. It comes with pre-defined templates, audit trails, configurable workflows, electronic signatures, and much more. Get detailed information on each module in the following presentation.
If you have any more questions, please get in touch with us at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.
Life Sciences benchmark survey on enabling technology used to support Quality Management Systems. The Benchmark Survey collected responses from LinkedIn's Quality & Regulatory Network.
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
This document discusses cells and their structure and function. It defines cells as the basic unit of life and outlines several key aspects of cells including their origins, requirements for life, types (prokaryotic and eukaryotic), organelles, sizes, and whether they are single-celled or multicellular. Important milestones in cell discovery are highlighted, such as Anton van Leeuwenhoek first observing cells in the 1600s and the development of the cell theory in the 1800s. The roles and structures of key cell organelles like the cell membrane, nucleus, mitochondria and chloroplasts are summarized.
DNA and RNA are nucleic acids that are made up of nucleotides containing a phosphate group, a 5-carbon sugar (ribose in RNA and deoxyribose in DNA), and a nitrogenous base. DNA exists as a double helix containing two anti-parallel strands bound together via hydrogen bonding between complementary nucleotide base pairs of adenine-thymine and cytosine-guanine. RNA is single-stranded and contains the base uracil instead of thymine. DNA stores genetic information in the nucleus, mitochondria, and chloroplasts, while RNA aids in protein synthesis and has various functions in the nucleus and cytoplasm.
9 regulatory compliance and validation for liWebseology
This document provides an overview of challenges facing the life sciences industry and discusses validation requirements for computer systems. It contains the following information:
- The pharmaceutical, medical device, and biotechnology industries face issues like loss of revenue from generics, high costs to develop new drugs, and new regulations. Computer validation is important in these regulated industries.
- FDA validation requirements are defined as demonstrating through documented evidence that a system consistently operates according to predetermined specifications. Validation ensures quality, objectivity, and that developers cannot check their own work.
- A validation toolkit is presented that follows GAMP 5 guidelines and parallels an established validation methodology. It contains templates, scripts, and tools to help customers efficiently validate computer systems in a
A GLOBAL LIFE SCIENCES COMPANY IMPLEMENTS ADAPTIVEGRC SOLUTION SUITE FOR VARIOUS GRC SERVICES
The customer is a global Life Sciences company operating in over 50 international markets. With $5bn annual turnover it has more than 4000 employees.
This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.
Parthiv Shah is a regulatory and compliance professional with over 10 years of experience in the medical device industry. He has successfully obtained 11 FDA 510(k) clearances in the last 4 years. He has also registered medical devices in countries across Europe, Asia, Australia, Canada, and others. Additionally, Shah has experience managing recalls and regulatory audits, submitting five MDR reports to the FDA and closing two recalls. Currently, he works as a Senior Regulatory Affairs Specialist at Vital Images, where he has led projects involving 510(k) submissions, international registrations, recalls, and regulatory audits.
Implementing a quality management system (QMS) provides regulatory benefits, improves market positioning, and enables continuous improvement. Regulatory bodies in the EU and US recognize QMS standards like ISO 13485 for medical devices. A QMS also increases customer satisfaction, reduces costs, and strengthens competitiveness. Continuous improvement, including preventative action, is a key benefit but also often underutilized aspect of a QMS. While establishing a QMS requires time and money for training and certification, the long-term advantages make it worthwhile for companies.
The document introduces Quality Vision, an integrated quality and safety management software solution. It consists of several modules that can be used together or separately, including quality and safety planning, control plans, complaint management, and quality system management. The software provides features like pre-requisite program management, integrated testing and sampling, and multi-level access controls. It is designed to help companies comply with standards, demonstrate quality controls, and integrate with other business systems.
Scott Buchheit is seeking a regulatory specialist position in the Minneapolis-St. Paul area. He has extensive experience in medical device regulatory affairs and FDA regulated environments, including authoring technical file documents for Europe and ensuring compliance of product literature. Buchheit has a Master's in Regulatory Affairs and Services from St. Cloud State University expected in December 2015, as well as certifications in quality management. He aims to apply his regulatory strategies and submissions experience, including for 510(k)s, PMAs, and IDEs, to a new position.
This document discusses computer system validation and process validation. It defines process validation as establishing evidence through all stages of production to consistently deliver quality products according to regulations. The FDA defines process validation as providing high assurance a process consistently meets specifications. Key concepts include three validation stages: process design, process qualification, and continued verification. There are four types of validation: prospective, retrospective, concurrent, and revalidation when changes are made.
Experience guide to or implementation and compliance 2015Edifecs Inc
Ready to kick-off a compliance project? Don’t miss this webinar; leverage our experience to accelerate your compliance programs. Understand the certification options. Gain insight to assist your organization maintain compliance after project completion. Understand how certification and partner communication can protect your organization.
5 Predictions for the Medical Device Industry in 2018 (and how you can prepare)Greenlight Guru
What should the medical device industry expect in 2018?
Great question.
From ISO 13485 being revised in 2016, the EU MDR / IVDR being revised in 2017, and the MDSAP program going live in 2017, regulatory changes have been rampant and significant for medical device professionals.
This presentation covers:
- Why you should expect it to be harder for devices to get to market and stay there in the EU
- How to avoid the mad dash to update ISO 13485 certification before the deadline
- Where the latest revision of ISO 14971 is and when to expect the next update
- About Health Canada and their MDSAP deadline
- Why companies are shifting from being compliance-focused to quality-focused
Watch the presentation, commentated by Greenlight Guru's founder Jon Speer, here: https://www.greenlight.guru/webinar/2018-medical-device-industry-predictions
The documentation system is key to cGMP and establishes formats and traceability. Documents must be maintained in a controlled manner and provide records for compliance. Written procedures exist for all production, quality control, packaging and labeling processes. Documentation provides organized information that serves as proof and answers for regulators: what is being done, why, if procedures are being followed, and if things are under control. The documentation system integrates tasks like generation, review, approval, distribution and retention/destruction of documents.
Paul E Schafer is a regulatory affairs specialist with over 5 years of experience in an ISO 13485 medical device manufacturing facility. He is looking to leverage his knowledge and experience in a role as a regulatory affairs specialist. His experience includes coordinating international device registration, managing complaint information, and facilitating regulatory support. He also has experience in quality roles such as document review, quality training management, and filling in as document control.
GTS Systems quality solutions for labs are both technology-oriented and standards-driven reliable, accurate, and smart results that aid in lab diagnosis and data management.
Independent Intelligent Quality Control Solutions Adopted By GTS Systems For Smartening, Modernize, and Highly Visualized Your Lab Data.
A dedicated audit management program helps streamline the audit preparation process and implements board directives by simplifying and systematically organizing the workflow. It allows companies to prove compliance with industry standards through internal and external audits required by their regulations. The program offers separate internal and external audit modules that use role-based security and provide a single source of control documentation for easy access.
Automated System Validation in FloridaAndre Butler
The document introduces the ADB Automation and Validation Group which provides expertise in fields like automated system validation, equipment validation, process validation, software validation, and FDA validation compliance. The group helps ensure manufacturing processes are flawless and products meet quality standards. It provides validation services for customers' specific automation and validation needs.
This is our framework to manage organizational operations and serve our clients. This includes various tools, architecture, models, documents, quality programs and many more steps that is beyond the enterprise limits.
The document describes a global solution for managing documents and processes for pharmaceutical companies called Stratesys QA-CAPA. It provides a corrective and preventive action (CAPA) management system that simplifies the identification, management, and closure of customer claims and non-conformities. The solution brings together best practices and technology to automate and monitor these critical business processes. It aims to significantly reduce customer complaints, minimize financial risks of non-compliance, and maintain compliance with quality and market regulations.
Best Enterprise Quality Management SoftwareQualityze Inc
Qualityze EQMS Suite is a comprehensive solution that enables organizations to proactively manage their quality, safety, and compliance issues while fostering a culture of continuous improvement. It is a set of ten powerful modules that helps to build a closed-loop quality management system. Each module comes with unique functionalities and can seamlessly integrate with the existing business applications to provide more control and confidence in managing data. It also enables you to make data-driven decisions to reduce overhead expenses.
Qualityze is an easy-to-customize, intuitive, and powerful quality management solution that can scale with your business’ ever-growing and changing needs. It is driven on a cloud platform, so you can leverage more flexibility and accessibility to manage business processes globally. It comes with pre-defined templates, audit trails, configurable workflows, electronic signatures, and much more. Get detailed information on each module in the following presentation.
If you have any more questions, please get in touch with us at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.
Life Sciences benchmark survey on enabling technology used to support Quality Management Systems. The Benchmark Survey collected responses from LinkedIn's Quality & Regulatory Network.
How to Prepare for the New EU In Vitro Diagnostics RegulationsGreenlight Guru
Agreement was reached on the eagerly awaited new EU In Vitro Diagnostic Regulations (IVDR) earlier this year.
The IVDR will significantly change the way IVDs bear the CE mark, and it will include a completely new risk-based classification system.
Now 80% of all IVDs will need to be certified by a notified body under the IVDR where as before, only 20% needed to under the IVD Directive.
The new IVDR is expected to be formally published in late 2016 or early 2017, and there will be a five-year transition period to be compliant.
Many forward thinking IVD companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
This presentation includes:
-Why the European regulations are changing
-What does the new regulation mean for IVD manufactures
-How to classify your IVD using the new risk-based classification system
-How to evaluate your existing clinical evidence to know if new studies will be needed to support your CE mark
-An overview of all the most significant changes brought by the IVDR
-What IVD manufactures can do to start preparing now
Watch the presentation here: https://www.greenlight.guru/webinar/eu-in-vitro-diagnostic-regulations-ivdr
This document discusses cells and their structure and function. It defines cells as the basic unit of life and outlines several key aspects of cells including their origins, requirements for life, types (prokaryotic and eukaryotic), organelles, sizes, and whether they are single-celled or multicellular. Important milestones in cell discovery are highlighted, such as Anton van Leeuwenhoek first observing cells in the 1600s and the development of the cell theory in the 1800s. The roles and structures of key cell organelles like the cell membrane, nucleus, mitochondria and chloroplasts are summarized.
DNA and RNA are nucleic acids that are made up of nucleotides containing a phosphate group, a 5-carbon sugar (ribose in RNA and deoxyribose in DNA), and a nitrogenous base. DNA exists as a double helix containing two anti-parallel strands bound together via hydrogen bonding between complementary nucleotide base pairs of adenine-thymine and cytosine-guanine. RNA is single-stranded and contains the base uracil instead of thymine. DNA stores genetic information in the nucleus, mitochondria, and chloroplasts, while RNA aids in protein synthesis and has various functions in the nucleus and cytoplasm.
This document discusses cellular processes related to energy and metabolism. It mentions cell respiration, both aerobic and anaerobic, photosynthesis, the electromagnetic spectrum, chloroplasts, and mitochondria, all in the context of how cells derive and use energy.
The document provides a summary of key concepts from chapters 1-4 of a textbook on body organization and homeostasis, nutrition, digestion, and circulation. It covers topics like the levels of body organization, homeostasis, nutrients and their functions, carbohydrates and fats, protein structure and function, vitamins and minerals, the digestive system process, circulation through the cardiovascular system, blood components, and respiration. The summary provides essential information on these topics in the form of questions and answers extracted from the textbook chapters.
Ionic bonding occurs when atoms gain or lose valence electrons to achieve stable noble gas configurations, becoming ions. Cations are positively charged ions formed when atoms lose electrons, while anions are negatively charged ions formed when atoms gain electrons. Ionic compounds are formed from electrostatic attractions between cations and anions, resulting in electrically neutral compounds. Ionic compounds usually have high melting points and conduct electricity when molten or dissolved in water.
The cell membrane protects the cell and regulates what passes in and out through passive and active transport. It is a phospholipid bilayer with proteins that allows the cell to maintain its shape and internal organization. Passive transport uses diffusion, facilitated diffusion, or osmosis to move molecules down their concentration gradients, while active transport requires ATP to pump molecules against gradients using integral membrane proteins like the sodium-potassium pump. The cell takes in and releases material through endocytosis and exocytosis.
Eggs can come from chickens, quails, emus or ducks. Eggs have an oval shape with a yolk surrounded by albumen and held within a hard shell. As eggs age, carbon dioxide and moisture pass through the shell, allowing older eggs to float in water while very fresh eggs will lie on their side or stand up straight in water. Eggs should be stored pointy-end down in the refrigerator away from odors and in their carton to retain moisture. Adding sugar or salt to egg whites can impact their ability to foam while beating. Eggs provide protein and various vitamins and minerals to the diet.
Cell division occurs through mitosis and cytokinesis to allow for growth, reproduction, and replacement of damaged or dead cells. Mitosis involves four phases - prophase, metaphase, anaphase, and telophase - where chromosomes are aligned and separated. Cytokinesis then divides the cytoplasmic components between the two daughter cells. Uncontrolled cell division can lead to tumor formation, which can grow large by recruiting blood vessels and metastasize by spreading to other parts of the body through the bloodstream. Common cancer treatments include surgery, radiation, and chemotherapy to kill actively dividing tumor cells, though it is difficult to remove all cancer cells and treatment must be carefully balanced.
This document provides an overview and reminders about informational and assessment writing assignments. It discusses different types of informational writing like expository, descriptive, essays, letters, critiques, newsletters, and articles. It also covers academic writing assessments like short constructed responses using the hamburger paragraph model, picture and poetry prompts, and extended responses. The document outlines characteristics of different essay types and provides examples of essay prompts. It discusses teaching strategies for informational writing and choices for a writing portfolio project. Students are reminded of upcoming assignments and interviews due.
This document summarizes the key components and functions of the human circulatory system. It describes the major parts of the system including the heart, blood vessels, and blood. It explains the different types of circulation including pulmonary, systemic, and coronary circulation. It also outlines the structures of the heart, types of blood vessels, blood pressure regulation, coronary heart disease, and how the heartbeat is controlled through the sinoatrial node and autonomic nervous system.
This document provides an overview of biological classification, describing the hierarchical system from kingdom down to species. It summarizes the key characteristics of major kingdoms including Plantae, Fungi, Protista, Archaebacteria, Eubacteria, and Animalia. Within Animalia, it outlines several phyla such as Porifera, Cnidaria, Platyhelminthes, Nematoda, Mollusca, Annelida, Arthropoda, Echinodermata, and Chordata. It also discusses key characteristics of plants, including bryophytes, ferns, conifers, and flowering plants.
The document summarizes the nervous and endocrine systems and homeostasis. It describes the central and peripheral nervous systems, including different types of neurons and how electrical impulses are transmitted between neurons. It also explains how hormones are released from endocrine glands and target tissues, and how negative feedback loops maintain homeostasis, such as in regulating blood glucose and temperature. Diseases like diabetes result from disruptions to these feedback mechanisms.
Hormones are chemical messengers that regulate various physiological processes. The hypothalamus controls the pituitary gland, which secretes hormones that target other endocrine glands like the thyroid. During digestion, glands like the stomach, pancreas, and intestines secrete enzymes and juices to break down food into absorbable nutrients. The small intestine absorbs these nutrients through epithelial cells lining villi using various transport mechanisms, then releases them into the bloodstream or lymphatic system.
1. Ecology is the study of living organisms in their natural environment and how they interact with each other and their nonliving environment.
2. An ecosystem consists of all the interacting living organisms (biotic factors) in a given area, as well as their nonliving (abiotic) environment. Key abiotic factors include temperature, water, soil and sunlight which influence which organisms can survive there.
3. Energy enters ecosystems through photosynthesis by autotrophs like plants, and is transferred between organisms through food webs as heterotrophs like animals consume other organisms to obtain energy. Nutrients are recycled through processes like the carbon and nitrogen cycles.
This document summarizes key aspects of DNA transcription. It describes the three main types of RNA - rRNA, tRNA, and mRNA. Transcription is the process by which RNA is made from a DNA template in order to convey genetic information from DNA to ribosomes for protein synthesis. During transcription, RNA polymerase binds to promoter regions and synthesizes a complementary RNA strand in the 5' to 3' direction until reaching a terminator region. The RNA codons formed during transcription correspond to DNA triplets. RNA processing occurs after transcription and involves splicing out introns and joining exons to form mature mRNA.
Eggs come in a variety of shapes and sizes from different birds like chickens, ducks, and emus. They have an internal structure including a yolk surrounded by albumen and held within a hard shell. The freshness of an egg can be tested by seeing if it sinks or floats in water, with very fresh eggs lying on their side at the bottom while older eggs will stand up or float. Eggs are best stored in their carton in the refrigerator and kept away from strong smells. When whipping egg whites, temperature, cleanliness, and absence of yolk are important for producing foam, and adding sugar or salt can impact the stability and volume of the foam produced.
La educación a distancia es una modalidad educativa en la que los estudiantes no necesitan asistir físicamente a las aulas y reciben materiales de estudio por correo electrónico u otros medios para completar en su hogar, permitiendo el acceso a la educación independientemente de la ubicación geográfica pero potencialmente causando aislamiento sin una adecuada interacción con tutores.
Este documento ofrece consejos para vivir la vida plenamente y apreciar cada momento. Recomienda pasar más tiempo con la familia y amigos en lugar de trabajar en exceso, usar cosas bonitas en lugar de guardarlas para ocasiones especiales, y expresar el amor a los seres queridos con frecuencia. También aconseja amar apasionadamente y tomar riesgos para vivir la vida en toda su intensidad.
Codex Validation Group is an engineering staffing and validation services company founded in Puerto Rico by professionals with over 25 years of combined experience in the pharmaceutical industry. The company provides validation, engineering, IT, and regulatory compliance services with a focus on computer and automation system validation. Its team of experts have experience across the product development lifecycle from process engineering to packaging and equipment qualification. The company aims to become a leader in technical services and regulatory compliance solutions for manufacturing clients.
Dan Mahaffey has over 15 years of experience in regulatory compliance and quality assurance across multiple industries. He holds certifications in quality management systems and medical device regulations. Currently, he works as a Supplier Quality Engineer for AlloSource, where he develops supplier quality programs and performs audits. Previously, he has held roles managing quality audits and corrective actions for medical device companies. He has expertise in international standards like ISO 9001, ISO 13485, and FDA and Health Canada regulations.
We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.
Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
This document provides a summary of Tajudeen A. Oladele's career experience in quality and regulatory engineering for medical devices. Some key points include:
- Over 25 years of experience in quality assurance, regulatory compliance, and engineering for medical devices.
- Held senior roles ensuring regulatory compliance and quality systems for various companies in the medical device industry.
- Extensive experience with international medical device regulations and standards including FDA, Health Canada, EU, and other global regulatory bodies.
- Track record of successful regulatory approvals and helping companies achieve regulatory compliance.
AxSource is a healthcare and information technology solutions provider specializing in consulting services for various industries including pharmaceutical, biologics, medical devices, and food. They provide regulatory, quality, engineering and IT consulting services to help clients with activities like new product launches and emerging market operations. AxSource consists of highly qualified consultants with decades of experience in North America, Europe, Mexico, and Asia.
Scheduled On : Thursday, October 10, 2013 at 01:00 PM EDT
Duration: 90 Minutes
This webinar is recorded
visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1130
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
Lori Benson has over 30 years of experience in quality systems and regulatory compliance across numerous industries. She has expertise leading quality assurance, inspection, documentation, and supplier evaluation. Benson has worked in medical device companies where she improved quality systems, gained FDA compliance, and resolved regulatory issues. She is skilled in quality management systems, auditing, process improvement, and training.
2013 Year of Pharmaceutical Serialization - Get it RightMichael Stewart
Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.
This document provides contact information and a summary of work experience for Patricia Madzik. She has over 20 years of experience in quality assurance testing and management in the health insurance industry. Her most recent roles include serving as a Test Lead ensuring successful application operation at Catholic Health Initiatives from 2014 to 2015 and working as a Quality Assurance Analyst at Davita Laboratory from 2013 to 2013. Prior to that, she held several senior QA and business analyst roles at Cigna Insurance, United Health Care Insurance, and Travelers Insurance, gaining extensive experience in testing, requirements analysis, and project management.
Angel Mario Jusino Berrios is an experienced registered pharmacist with extensive experience in the pharmaceutical industry, managing consent decrees and ensuring regulatory compliance. He has held senior roles providing quality consulting services, including implementation of validation guidelines, quality system assessments, and preparation of regulatory reports. Berrios has expertise in areas such as quality system implementation, process validation, remediation programs, auditing, and technical strategies.
This document provides information about Validation, Inc., an organization that offers various validation and compliance services to clients in regulated industries. It summarizes the company's mission, goals, staff size, services offered, and approach to projects. Validation, Inc. aims to establish long-term client relationships through trust, accountability and a repeat business rate of over 90%. The company's services include detail design review, commissioning, calibration management, equipment qualification, process validation, cleaning validation, and computer system validation.
ChemPharm is a consulting firm that provides expert services to support the pharmaceutical, biotechnology, medical device, traditional Chinese medicine, and cosmetic industries. It helps clients achieve compliance with international standards through services such as quality management system development and upgrades, validation, regulatory affairs support, and training. ChemPharm works with a variety of clients from multinational corporations to national companies and start-ups. Its goal is to be a trusted partner through high integrity, professionalism, and sharing of strategic information and vision.
Yonix presents: Building the world's most sophisticated tb eradication softw...yonix
Building the world's most sophisticated TB eradication software solution.
In 2009 the Animal Health Board (AHB), who are responsible for managing New Zealand's bovine tuberculosis (bovine TB) programme, arguably completed one of the most successful software development projects in New Zealand.
The project was a great success story, delivered on time, within budget and was functionally fit for its purpose. The project took top honours at the 2008 Computerworld Awards for Excellence, winning both the Overall Excellence in the Use of ICT award and the Innovative Use of ICT award.
What distinguished this project from the typical software development project? And what role did the business analysts play in determining the success of this project?
Learning Outcomes:
• Factors critical to the success of software development projects
• How to achieve excellence in requirements and analysis
• Using business analysis to create success of software development projects
Douglas Cruz-Alvarez has over 15 years of experience in aerospace quality assurance and engineering management. He is currently the Site Quality Manager at UTC Aerospace Systems in Albuquerque, NM, where he has reorganized teams, improved processes, and driven cultural changes. Previously, he held quality leadership roles at Honeywell and Bogue Machine Company, implementing quality management systems, achieving certifications, and improving metrics like cost of poor quality, supplier performance, and customer satisfaction.
Avanceon is an industry leader in manufacturing automation and IT solutions since 1984. They provide a full suite of services including process automation, MES implementations, custom software, regulatory validation, and long-term support. Their services help clients maximize productivity, improve efficiencies, ensure quality and compliance, and gain a competitive advantage. Avanceon takes a holistic life cycle approach to projects and provides long-term support through innovative programs and dedicated resource teams.
The document is a resume for Mark R. Jones, who has over 20 years of experience in manufacturing quality roles. He has a background in process improvement, quality system audits, root cause analysis, and training. His most recent role was as Organic Coatings Operations Manager for Freedom Metal Finishing, where he increased capacity and quality. Prior to that he held several roles over 10 years at Seaway Plastics/Florida Finishing, growing the company and implementing lean manufacturing practices.
Svetlana Veprinsky is a senior level technical professional with over 20 years of experience in project management, process engineering, quality assurance, and regulatory compliance. She has a proven track record of successfully delivering complex IT projects and process improvements on time and within budget. She is skilled at analyzing processes, implementing streamlining techniques, and managing teams to meet organizational objectives.
This presentation reviews the regulatory requirements for intended use validation of SaaS-based EDC systems from the Sponsor and CRO perspective and provides best practices for implementing the proper validation in your organization.
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
NAVIGATING THE HORIZONS OF TIME LAPSE EMBRYO MONITORING.pdfRahul Sen
Time-lapse embryo monitoring is an advanced imaging technique used in IVF to continuously observe embryo development. It captures high-resolution images at regular intervals, allowing embryologists to select the most viable embryos for transfer based on detailed growth patterns. This technology enhances embryo selection, potentially increasing pregnancy success rates.
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
Know the difference between Endodontics and Orthodontics.Gokuldas Hospital
Your smile is beautiful.
Let’s be honest. Maintaining that beautiful smile is not an easy task. It is more than brushing and flossing. Sometimes, you might encounter dental issues that need special dental care. These issues can range anywhere from misalignment of the jaw to pain in the root of teeth.
Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
1. An Introduction to Reglera Products and Services Brian Tucker Director of Business Development [email_address]
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Editor's Notes
Intro: Introduce Reglera attendees Read intro verbatim Transition: Although these are lofty goals and aspirations, I think you will see how this simple statement is directly linked to everything we do and the outcomes we achieve. Reglera’s management team has been working in the Medical Device market space for decades. During this time we learned that there are some specific, fundamental challenges that face everyone in this industry. Key Outcomes: Introduce the purpose of our business Begin to establish credibility set the stage for the introduction of the problem set on the next page