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Quality by design-QbD -  Pharmaceuticals industry
 
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The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
Views: 2268 Pharmansh
Pharma Industry Quality by Design-QbD
 
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Quality is, for reasons quite obvious, extremely crucial to the pharmaceutical industry in general. Poor quality medicines present severe damages not only to public health but to the government exchequer as well, not to forget the good will of the company concerned. But since the early 2000s, quality assurance has become even more significant to pharma companies as the global community came together to standardize practices and processes for quality management in the sector, not least of them the current Good Manufacturing Practices (cGMP) by Food and Drug Administration in the United States. World Health Organization also has its own version of the GMP. The quality of a pharmaceutical product lies in its ability to deliver the therapeutic value promised to the consumer, in addition to being free of contamination. A quality of pharmaceuticals can be evaluated whether by in vivo (“within the living”) or in vitro (“within the glass”) performance tests. And this is where Quality by Design (QbD) comes in. Quality by design helps achieve in vitro performance, which in turn facilitates in vivo performance. Find Out [email protected] https://www.questmasterclass.com/works/2nd-annual-pharmaceutical-quality-data-integrity-excellence-2017/
Views: 2175 QuestMasterClass
Quality by Design
 
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Views: 15496 MasterControl
Quality by Design in Product Development
 
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Paper:-Product development Part 2 Subject:-Pharmaceutical Science
Views: 1354 Vidya-mitra
Quality by Design (QbD) in Pharmaceutical Development
 
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A five day executive course on Quality by Design (QbD). QbD is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element in a stream-lined drug development process. Link to course description: http://copenhagensummeruniversity.ku.dk/en/courses/qualitybydesign/
Quality by Design
 
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Quality by Design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned. While Quality by Design principles have been used to advance product and process quality in every industry, and particularly the automotive industry, they have most recently been adopted by the U.S. Food and Drug Administration (FDA) as a vehicle for the transformation of how drugs are discovered, developed, and commercially manufactured. This video is targeted to blind users. Attribution: Article text available under CC-BY-SA Creative Commons image source in video
Views: 2664 Audiopedia
A Holistic approach of QbD in Pharmaceutical Industry
 
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Quality by design (QbD) is an approach for process development to ensure the patients’ needs and product performance by which quality is not just tested in the final drug substance but is built within the process. (Process) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (Science) The prime aim of the QbD is to achieve the right quality product by right first time (Business) Facilitate continuous improvement with a reduced need for post-approval changes. (Regulatory)
Using Quality by design to better understand your HPLC methods
 
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QBD presentation by John Dolan. To register to view this presentation in full for free plus others please visit the link below: http://view6.workcast.net/?pak=4801729417668583
Views: 453 Separation Science
An Effective Roller Compaction Process in a Quality by Design (QbD) Environment
 
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A description of the Roller Compaction process and the various process parameters that affect the quality of the roller compacted ribbons. Feed rate, compaction pressure, and roll speed are all discussed. Poor control of these parameters can affect Critical Quality Attributes (CQAs) such as tablet hardness, tablet or capsule weight, tablet friability, and dissolution rates. Ribbon density and porosity are also discussed as they affect both downstream processing and final product attributes, one of the most important being tablet dissolution rate. When implementing Process Analytical Technology (PAT), density and porosity measurement of roller compacted ribbons can help to ensure consistent output of the roller compaction unit operation. The process design scientist, working with formulators, scale-up personnel, technology transfer personnel, and manufacturing can use this in-process density and porosity check to ensure product quality, process efficiency, and reduce the chance of failure during product quality control testing.
Views: 5239 Micromeritics
Beginning Graphic Design: Fundamentals
 
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In this video, you’ll learn the fundamentals of graphic design. Visit https://www.gcflearnfree.org/beginning-graphic-design/fundamentals-of-design/1/ for our text-based lesson. This video includes information on the main elements of art and design, including: • Line • Shape • Form • Texture • Balance • The rule of thirds We hope you enjoy!
Views: 1218932 GCFLearnFree.org
Quality by Design (QbD) Space for Pharmaceuticals and Beyond
 
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Quality by Design (QbD) is a hot topic in the pharmaceutical industry, heavily promoted by the FDA. However, these tools should be used by every industry interested in producing high-quality products. The general concepts are not new, but the tools to implement them have dramatically improved in the last few years. This presentation provides a briefing on QbD along with state-of-the-art response surface methods (RSMs) for developing a robust design space.
Quality By Design USFDA
 
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Quality By Design USFDA
Quality by Design in Clinical Trials  Risk Assessment (Part 1)
 
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The first, and perhaps most important step in adopting Risk-Based Monitoring, is conducting a Risk Assessment. We’ll discuss different tools for Risk Assessment. We will demonstrate how Risk Assessment affects data collection, monitoring and data management plans and timing and how you can start today.
QbD "Speedometer" : Basics of Quality by Design by QbD-Expert™
 
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QbD Speedometer will help you to understand how principle steps of Quality by Design system can be implemented sequentially & systematically from targeting to controlling during development of Pharmaceutical Generic Drug Product.
Views: 63 QbD-Expert
Schmidt and Stanic - Quality by Design Development of a Purity Method Using UPLC and Mass Detection
 
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Watch on LabRoots at http://labroots.com/user/webinars/details/id/361 Traditional method development, in which an LC method is developed principally by trial-and-error, is time consuming and may not result in a robust method. In addition, taking this approach provides no understanding of the influence of key factors on the results. Conversely, modern systematic method development strategies using statistical or modeling software tools to generate experimental designs and explore method robustness offer numerous advantages and can provide a fast and efficient approach for method development. Chromicent GmbH (Berlin, Germany) managing directors Alexander Schmidt and Mijo Stanic are experts in the development and validation of analytical methods according to the latest quality-by-design approaches. The aim of their recent work has been to apply quality-by-design principles to build in a more scientific and risk-based, multifactorial strategy in the development of a new UHPLC methods. In this webinar, they will describe the application of their approach in the development of a new purity method for a well known API. The final method, with an analysis time of only 4 minutes, provides a 40-fold increase in productivity compared to the existing method published in the European Pharmacopeia.
Views: 456 LabRoots
The first secret of great design | Tony Fadell
 
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As human beings, we get used to "the way things are" really fast. But for designers, the way things are is an opportunity ... Could things be better? How? In this funny, breezy talk, the man behind the iPod and the Nest thermostat shares some of his tips for noticing — and driving — change. TEDTalks is a daily video podcast of the best talks and performances from the TED Conference, where the world's leading thinkers and doers give the talk of their lives in 18 minutes (or less). Look for talks on Technology, Entertainment and Design -- plus science, business, global issues, the arts and much more. Find closed captions and translated subtitles in many languages at http://www.ted.com/talks/tony_fadell_the_first_secret_of_design_is_noticing Follow TED news on Twitter: http://www.twitter.com/tednews Like TED on Facebook: https://www.facebook.com/TED Subscribe to our channel: http://www.youtube.com/user/TEDtalksDirector
Views: 955065 TED
7 principles for building better cities | Peter Calthorpe
 
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More than half of the world's population already lives in cities, and another 2.5 billion people are projected to move to urban areas by 2050. The way we build new cities will be at the heart of so much that matters, from climate change to economic vitality to our very well-being and sense of connectedness. Peter Calthorpe is already at work planning the cities of the future and advocating for community design that's focused on human interaction. He shares seven universal principles for solving sprawl and building smarter, more sustainable cities. Check out more TED Talks: http://www.ted.com The TED Talks channel features the best talks and performances from the TED Conference, where the world's leading thinkers and doers give the talk of their lives in 18 minutes (or less). Look for talks on Technology, Entertainment and Design -- plus science, business, global issues, the arts and more. Follow TED on Twitter: http://www.twitter.com/TEDTalks Like TED on Facebook: https://www.facebook.com/TED Subscribe to our channel: https://www.youtube.com/TED
Views: 692866 TED
Quality by Design in Clinical Trials  Lessons Learned in Implementing Risk Based Monitoring
 
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We have learned two valuable lessons in implementing Risk-Based Monitoring: “Don’t let perfect be the enemy of good” and “Risk-Based Monitoring is an iterative process”. In today’s webinar, we will discuss some of our lessons learned in implementing Risk-Based Monitoring.
Utilizing the Research Ethics Review Process as a Method to Incorporate Quality by Design
 
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Gregory Staios, MSc, CCRP, Manager, Research Quality and Privacy, St. Michael's Hospital, Applied Health Research Center SOCRA's 2018 Annual Conference Mr. Staios will describe the actions taken to incorporate quality by design principles into the conduct of human participant research at the Centre for Addiction and Mental Health. A framework of the approach and the main outcomes of this process change will be presented.
Views: 370 SOCRA
TYPES OF QUALITY, IES GS ,STANDARDS AND QUALITY PART 3
 
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THIS video explains the types of quality - includes quality of design , quality of conformance, quality of performance #sehwagsacademy for more videos ..#sehwagsacademy fb page -https://www.facebook.com/IEStargetrock/ you tube channel-https://www.youtube.com/channel/UCzXz... If you like my video then please like , share and subscribe my channel.. THANK YOU
Views: 694 TARGET IES
Hygienic design principles
 
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http://aco.si
Views: 479 ACO Slovenija
How To Design A Quality Poster | Poster Designing Tips
 
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Today we look at how to design a quality poster, using my poster designing tips. The tips that I have for you on how to design a poster, all are very relevant and will enable you to design a quality poster. So tune in and watch this tutorial on poster design top tips! It’s Tom with Satori Graphics back with another graphic design tutorial; today poster designing tips! I have seven of them in total, and all of the tips on how to design a quality poster are not related to the technical aspects of poster design i.e how to lay out a poster in Adobe Illustrator, or what is a bleed? I have other videos explaining things such as that on my channel. This video on poster designing tips, relates to the process, and the style of a poster. How to use techniques to grab the attention of the viewer, and to create a visually appealing poster design. So tune in and learn how to design a quality poster, today! If you found this graphic design upload on poster designing tips enjoyable or useful, let me know in the comments section and drop a like on your way out. Subscribe to stay updated to all of my uploads and until next time, design your future today, peace Grab 40+ Fonts & Licenses for ONLY $29 https://thehungryjpeg.com/bundle/3502855-the-now-or-never-november-bundle/DT1s0cgmDG/ ➤➤ Do YOU Need Web Hosting For Your Website? Grab Yourself A GREAT Deal Here With My Affiliate Link! https://www.bluehost.com/?utm_source=www.bluehost.com&utm_medium=affiliate&utm_campaign=affiliate-link_satorigraphics_notype ***** ✪ COOL GRAPHIC DESIGN GADGETS AND RESOURCES ✪ ***** PERFECT Book For Logo Designers ➤➤ http://amzn.to/2uqZiCi Grab Yourself The Same Camera I Use For My Videos ➤➤ http://amzn.to/2AS8gxd Professional AND Affordable Wacom Tablet ➤➤ http://amzn.to/2s1sNrJ ***************** SUBSCRIBE TO SATORI GRAPHICS ***************** ➤➤ https://www.youtube.com/channel/UCoeJKtPJLoIBqWq4o8TDLpA My most recent graphic design tutorial: https://youtu.be/u8AfiylRgnc Check out this playlist on logo design tutorials: https://www.youtube.com/watch?v=m_uuUfGGJLc&list=PL-c9Rq56P4KkAg-9RTfMlTglR-gFR-EzI&t=244s&index=1 ***************** MUSIC ***************** Lets Go Surfing by Joakim Karud, check his music out here https://soundcloud.com/joakimkarud/va Enjoy by Joakim Karud, check his music out here https://soundcloud.com/joakimkarud/va ***************** SOCIAL NETWORKS ***************** ➤ TWITTER: https://twitter.com/satorigraphic2k ➤ INSTAGRAM: https://www.instagram.com/satori_graphics/ ➤ PINTEREST: https://uk.pinterest.com/satorigraphics/ ▶ Copyright The work is protected by copyright. This is applied to the video recording of itself as well as all artistic aspects including special protection on the final outcome. Legal steps will have to be taken if copyright is breeched. Music is used from the YouTube audio library and thus copyright free music. https://youtu.be/ldBUUKRQR9M
Views: 111846 Satori Graphics
Advanced Pharmaceutical Manufacturing
 
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There are a number of challenges that the industry faces in order to transition towards more competitive, systematic and efficient manufacturing. Regulatory authorities have recognized the deficiencies of pharmaceutical product manufacturing and aim to enhance process understanding through Quality by Design (QbD) and Process Analytical Technology (PAT) tools. As a result of this current effort to change the mindset in order to mimic the rest of the chemical industry, an additional transition is becoming more and more appealing: transition from batch to continuous production mode. However, continuous manufacturing requires detailed process understanding in terms of the evolution of all critical material properties as a function of its operating parameters and environmental conditions. Once process knowledge is translated into models, computer aided dynamic simulation tools will allow the design, analysis and optimization of continuous integrated processes. In this talk I will discuss the work that has been done in my lab towards the development of an integrated platform that will enable the efficient flowsheet simulation and analysis, the assessment of design alternatives, the feasibility analysis of the production line, and the control and optimization of process design and operations. The developed flowsheet model includes modules for all the necessary unit operations, namely powder feeding, mixing, roller compaction, tablet press and milling integrated to represent a tablet manufacturing line. Models used to represent each unit operation vary from empirical, first-principle or hybrid. Population balance models are developed in order to track the composition and particle size changes throughout complex powder processes dynamically. The developed flowsheet simulation is used to predict the propagation of upstream disturbances to final product quality, the assessment of recycle stream benefits, the identification of process integration bottlenecks and evaluation of different control strategies in order to retain the process within its design space. In addition, global dynamic sensitivity analysis is performed to identify critical process parameters not only within each unit operation, but also between different processes. Finally, simulation based optimization techniques enable the identification of the optimal operating conditions, as well as the optimal design sequence which leads to pharmaceutical tablets with desired characteristics. This work aims to merge knowledge, experience, experimental results and modeling tools for developing a dynamic simulation platform that will enable the safe implementation of the transition towards continuous pharmaceutical manufacturing. Biography: Marianthi Ierapetritou is a Professor and Chair in the Department of Chemical and Biochemical Engineering at Rutgers University in Piscataway, New Jersey. Dr. Ierapetritou’s research focuses on the following areas: 1) process operations; (2) design and synthesis of flexible production systems focusing on pharmaceutical manufacturing; 3) modeling of reactive flow processes; and 4) metabolic engineering with focus on biopharmaceutical production. Her research is supported by several federal (NIH, NSF, ONR, NASA) and industrial (BMS, J&J, ExxonMobil, Honeywell, Cardinal Health) grants. Among her accomplishments are the Outstanding Faculty Award, the Rutgers Board of Trustees Research Fellowship for Scholarly Excellence, and the prestigious NSF CAREER award. She has more than 180 publications, and has been an invited speaker to numerous national and international conferences. Dr. Ierapetritou obtained her BS from The National Technical University in Athens, Greece, her PhD from Imperial College (London, UK) in 1995 and subsequently completed her post-doctoral research at Princeton University (Princeton, NJ) before joining Rutgers University in 1998.
Views: 45204 APMonitor.com
Webinar #3: Promising Practices and Design Principles in Quality for Distance CTE
 
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This is a recording of the third and final session of APEC’s Digital Workforce Development Project webinar series, where speakers discuss promising practices and design principles in quality for career and technical education programs delivered via distance learning technology. *Watch the webinar in full or click on the time markers in the description box below to skip to a specific presentation.* Today’s workers across the Asia-Pacific region are finding that jobs increasingly require new and innovative digital skills and competencies. However, effective training in and delivery mechanisms for such skills are in short supply creating barriers to both gainful employment and an efficient workforce. To address these needs and improve career and technical education (CTE) in the region, the United States Department of Education sponsored the APEC Digital Workforce Development (DWD) Project through the Asia-Pacific Economic Cooperation (APEC) Education Network. The DWD Project’s activities, openly accessible products, and constructive collaboration will benefit project participants, APEC delegates, and stakeholders in all member economies. To learn more, please visit our website at https://tech.ed.gov/apec-digital-workforce-development-project and view Webinar #1 at: https://youtu.be/u0jfXBUeseI, then view Webinar #2 at: [Please insert link] *Agenda (click on timestamp to jump ahead)* 0:27 Welcome & General Introduction of Project & Schedule: Dr. Jadon Marianetti – Project Overseer & International Affairs Specialist, Office of the Secretary, United States Department of Education 4:39 Subject Matter Expert Presentation on Quality in Distance CTE: Dr. Tonya Joosten, Director of Digital Learning Research and Development, University of Wisconsin‐Milwaukee 24:49 United States Policy Maker: Amy Lorenzo, Policy Director for the State of Idaho Division of Career & Technical Education 48:02 Australian Policy Maker: Karen Treloar, Director of the Engagement Group at the Australian Government Tertiary Education and Quality Standards Agency (TEQSA) 1:07:58 Closing Remarks: Dr. Jadon Marianetti, United States Department of Education
Views: 55 Office of Ed Tech
5 MIND BLOWING Logo Design Tips ✍
 
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So over the past couple years, I've given a lot of advice when it comes to designing logos. So here are 5 insane logo design tips for anyone who's just beginning their logo design journey, or well within their journey! Sponsored by Squarespace! 10% OFF code: PATERSON http://www.squarespace.com/williampaterson Great Graphic Design Resources! https://creativemarket.com?u=Willberto Instagram: http://instagram.com/willpat Thanks for watching! Hope you enjoyed this video! If there's anything you would like me to cover in a Youtube Video, then let me know by commenting down below! If you like what I do, and you want to partner with me: Partner with me through Patreon : http://patreon.com/user?u=35829 Buy a T-Shirt or Poster,where some of the profits go staright to charity http://www.prophesyapparel.co.uk Hire me: http://www.williampatersondesign.com If you would like me to design you a logo, poster or anything for your Youtube Channel or business, then I'm your man! I would love to work with you to make what you want a reality! Check out my website and portfolio for more information. Hire me: http://www.williampatersondesign.com
Views: 1095585 Will Paterson
Quality by Design (QbD) in Process Development for Freeze-Dried Parenterals
 
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View full webinar at: http://www.SPScientific.com/QbD-Freeze-Dried-Parenterals Case study presented to illustrate one approach that includes the essential elements of QbD: identifying a target product profile and quality attributes, a formalized risk assessment process, utilization of prior knowledge to design a meaningful experimental approach, and finally determining both a formulation design space and a process design space, where the process design space incorporates limitations on the process imposed both by the characteristics of the product and the capability of freeze drying equipment.
Views: 1018 spscientific
What is PROCESS VALIDATION? What does PROCESS VALIDATION mean? PROCESS VALIDATION meaning
 
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✪✪✪✪✪ WORK FROM HOME! Looking for WORKERS for simple Internet data entry JOBS. $15-20 per hour. SIGN UP here - http://jobs.theaudiopedia.com ✪✪✪✪✪ ✪✪✪✪✪ The Audiopedia Android application, INSTALL NOW - https://play.google.com/store/apps/details?id=com.wTheAudiopedia_8069473 ✪✪✪✪✪ What is PROCESS VALIDATION? What does PROCESS VALIDATION mean? PROCESS VALIDATION meaning - PROCESS VALIDATION definition - PROCESS VALIDATION explanation. Source: Wikipedia.org article, adapted under https://creativecommons.org/licenses/by-sa/3.0/ license. SUBSCRIBE to our Google Earth flights channel - https://www.youtube.com/channel/UC6UuCPh7GrXznZi0Hz2YQnQ Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. Design of experiments is used to discover possible relationships and sources of variation as quickly as possible. A cost benefit analysis should be conducted to determine if such an operation is necessary. Quality by Design is an approach to pharmaceutical manufacturing that stresses quality should be built into products rather than tested into products; that product quality should be considered at the earliest possible stage rather than at the end of the manufacturing process. Input variables are isolated in order to identify the root cause of potential quality issues and the manufacturing process is adapted accordingly. Process Analytical Technology is used to measure critical process parameters (CPP) and critical quality attributes (CQA). PAT facilitates measurement of quantitative production variables in real time and allows access to relevant manufacturing feedback. PAT can also be used in the design process to generate a process qualification. Critical Process Parameters Operating parameters that are considered essential to maintaining product output within specified quality target guidelines. Critical Quality Attributes (CQA) are chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits. CQA are an essential aspect of a manufacturing control strategy and should be identified in stage 1 of Process Validation: Process design. During this stage acceptable limits, baselines, and data collection and measurement protocols should be established. Data from the design process and data collected during production should be kept by the manufacturer and used to evaluated product quality and process control. Historical data can also help manufacturers better understand operational process and input variables as well as better identify true deviations from quality standards compared to false positives. Should a serious product quality issue arise, historical data would be essential in identifying the sources of errors and implementing corrective measures. Design Space Verification confirms that quality can be guaranteed within an identified range of input and operating variables. Continued Process Verification is the ongoing monitoring of all aspects of the production cycle. It aims to ensure that all levels of production are controlled and regulated. Deviations from prescribed output methods and final product irregularities are flagged by a process analytics database system. The FDA requires production data be recorded (FDA requirements (§ 211.180(e)). Continued process verification is stage 3 of process validation. The European Medicines Agency defines a similar process known as Ongoing Process Verification. This alternative method of process validation is recommended by the EMA for validating processes on a continuous basis. Continuous Process Verification analyses Critical Process Parameters and Critical Quality Attributes in real time to confirm production remain within acceptable levels and meet standards set by ICH Q8, Pharmaceutical Quality Systems, and Good manufacturing practice.
Views: 12019 The Audiopedia
Five Rules of Design Thinking to Reach All Students | Michael Roush | TEDxWorthingtonED
 
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Reaching a widely diverse group of students requires flexible means and methods. These “Five Rules of Design Thinking” will help any teacher find new ways to approach the important work of providing quality educational opportunities to each and every student. Careful attention to the design process has the potential for overcoming many barriers before they become obstacles to student achievement. The “Rules” come from the lives of historical figures and examples of the barriers that they faced, and the unique ways they overcame them. We can use the same ideas today. Michael Roush specializes in educational technology, assistive technology, and Universal Design for Learning. Michael has previously taught at the high school and college level, and worked for over 10 years providing school improvement and special education consulting with the Ohio Region 14 State Support Team. He currently serves as Customer Service Coordinator in the IT Department at Wilmington College. Michael and his wife, Angie, live in rural southwestern Ohio. They have four adult children, and two in elementary school. This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at http://ted.com/tedx
Views: 26485 TEDx Talks
Fusion QbD Software Demo
 
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S-Matrix develops advanced and innovative approaches to experimental design and multivariate data analysis according to Quality-by-Design principles. S-Matrix has strategic business alliances with international Pharmaceutical, Analytical Instrument, and Process Equipment companies.
QbD Speedometer: From Targeting to Controlling (Designed & Developed under QbD Expert™)
 
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QbD Speedometer will help you to understand how principle steps of Quality by Design system can be implemented sequentially & systematically from targeting to controlling. 1. How to define Quality Target Product Profile (QTPP)? – Customer Voice Recorder 2. How to determine Critical Quality Attributes (CQAs)? – Impact Analyzer 3. How to assess risks of Critical Material Attributes (CMAs) & Critical Processing Parameters (CPPs)? - Fishbone, Check sheet Matrix, FMEA (Severity * Probability * Detectability)? 4. How to reduce probability of occurrence? - Design of Experiments (DoE) for CMAs & CPPs to develop Design Space 5. How to increase detectability of risks? - Process Analytical Technology (PAT) with Process Qualification & Validation 6. How to implement Control Strategy for CMAs & CPPs for commercial manufacturing? – Variable & Attribute Control Charts 7. How to ‪manage product life cycle by Continual Improvement? – Continual Trend Analysis with PDCA.
Views: 1719 Dr. Shivang Chaudhary
MDICx August 16, 2016 - Clinical Trial Quality By Design
 
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In 2015, the Clinical Trials Transformation Initiative’s Quality by Design Project published their CTTI Quality by Design Project – Critical to Quality (CTQ) Factors Principles document intended to “support proactive, cross-functional discussions and decision making at the time of trial development about 1) what aspects of a trial are critical to generating reliable data and providing appropriate protection of research participants (“critical to quality” [CTQ] factors) and 2) what strategies and actions will effectively and efficiently support quality in these critical areas.” MDIC’s Clinical Trial Design working group supported CTTI’s approach to identifying the factors that matter in clinical trials in order to generate reliable data, but recognized there are some challenges specific to medical device clinical trial. In addition to CTTI’s comprehensive set of recommendations, the MDIC Clinical Trial Design working group has created a supplement with some additional considerations for quality and efficient medical device clinical trials. The supplement was released in 2016, along with a report on an MDIC study of data collection in medical device clinical trials. This webinar was a joint presentation with CTTI and MDIC. Speakers: Susan Alpert – MDIC Clinical Trial Design working group chair Ann Meeker-O’Connell – CTTI Quality by Design project team
Building Green Manufacturing on a Foundation of PAT and QbD
 
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http://www.mt.com/pat?GLO_YT_Autochem_OTH_Youtube_Autochem Process Analytical Technology (PAT) framework and green manufacturing initiatives complement and reinfoce each other in the pursuit of research and manufacturing in the pharmaceutical industry. Although they began on different paths, the Principles of Green Chemistry and Engineering share plenty of common ground with the Quality by Design (QbD) and Process Analytical Technology (PAT) initiatives. Full process optimization must take a holistic view of health, safety, environment and economic concerns; and applying the principles of Quality by Design (QbD) and Process Analytical Technology (PAT) to the design of a robust pharmaceutical manufacturing process should result in improvements in process efficiency, process consistency, and product quality. The application of QbD builds a higher level of process understanding to facilitate the robust design and scale-up of optimized processes. The application of PAT enables the monitoring and control of manufacturing processes to minimize wasted time, energy and raw materials – assuring product quality while improving overall production throughput and profitability. Although the QbD and PAT efforts extend beyond a goal of safe and sustainable manufacturing, many of their objectives are in complete agreement with select principles of Green Engineering which emphasize maximizing efficiency, preventing waste (rather than treating it), and reduction of energy consumption.
Views: 334 MettlerToledoAC
What is UX Design? Defining User Experience Design & Explaining the Process
 
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Jose and Chris explain what UX Design is by working on the redesign of The Skool's website. User Experience Design (UXD) is the process of enhancing user satisfaction by improving the usability, accessibility, and pleasure provided in the interaction between the user and a product or service. If you've ever been curious about UX or want to see Jose do "his UX thing" this is an episode to watch. You'll also see how we design more effective landing pages by thinking about what our "users" challenges/pain points are, and then addressing them through messaging. You should always consider... Who the Customer is. What their challenges are. How can YOU solve them? ...and confront possible user objections and questions such as... "Is this for me?" "Does it work?" "What is it exactly?" Annotations by Hunter Hemingway 1:00 What is User Experience Design 1:54 User Experience Wheel 3:15 Defining the Goal of the Redesign 4:25 Defining User Personas #1 6:03 Defining User Challenges #1 7:29 Defining Solutions #1 10:30 Defining User Personas #2 11:00 Defining Challenges #2 12:52 User Experience Questions 13:08 Defining Solutions #2 13:50 Awareness of Sharpie & Size ;) 14:08 Choosing/Prioritizing Your Personas 15:08 Choosing Most Important Challenges to Tackle 16:10 Choosing Solutions in Tandem with Challenges 18:20 Format & Translation to Screen 19:12 Team Designing Format 20:06 Defining Objections 20:15 Sales Process Layout 22:20 Headline/Attention/Copywriting Tip 22:53 Answering For Me?/Challenges 24:52 Answering Does it Work? 26:20 Answering What is it? 27:44 Team Designing Format Layout** 29:38 Translating Core with Empathy for the User 31:50 Product Architecture 32:40 Creativity with Existing Functionality & Formatting _________________________________________________ 👉Subscribe: https://goo.gl/F2AEbk 👉See our Academy Channel: https://goo.gl/vB9zoP Want a deeper dive? Typography, Lettering, Sales & Marketing, Social Media and The Business of Design courses available here: https://goo.gl/bRt5qd — Love the content? Become a sustaining member for $5/mo today. https://goo.gl/nwekfL Our BOOKLIST: https://goo.gl/onrdxr Kits & Proposals: https://goo.gl/mSjuWQ Visit our website: https://www.thefutur.com FREE resources: https://goo.gl/Qh6gHr Mandarin (Chinese) Subtitles on UiiUii https://uiiiuiii.com/?s=the+futur — We love getting your letters. Send it here: The Futur c/o Chris Do 1702 Olympic Blvd. Santa Monica, CA 90404 USA — OUR AFFILIATE LINKS Webflow: http://bit.ly/2EbET9l Retro Supply Co.: http://bit.ly/2GW8gzR Skillshare: https://goo.gl/YCo2uT Amazon: http://a.co/7abg3DD Creative Market: https://goo.gl/g4jlTE Design Cuts: http://bit.ly/2GSsAR3 Epidemic Sound: https://bit.ly/2T647tR Bring Your Own Laptop Tutorials: byol.me/thefutur  By making a purchase through any of our affiliate links, we receive a very small commission at no extra cost to you. This helps us on our mission to provide quality education to you. Thank you. — Futur Podcast on iTunes: 🎙 https://itunes.apple.com/us/podcast/the-futur/id1209219220?mt=2 Spotify: 🎙 https://open.spotify.com/show/5K96ryZCjCmxqMzEotvS8h?si=J0NnGXwcQCymfBEA4poEVA Jose Caballer: https://twitter.com/joseCaballer Chris Do: https://twitter.com/theChrisDo Aaron Szekely: https://twitter.com/AaronSzekely Credits: Executive Producer– Chris Do Hosts– Chris Do & Jose Caballer Director– Andrew Truong Cameraman– Aaron Szekely Producer– Aaron Szekely Editor– Aaron Szekely Musical Director– Adam Sanborne === *By making a purchase through any of our affiliate links, we receive a very small commission at no extra cost to you. This helps us on our mission to provide quality education to you. Thank you.
Views: 466772 The Futur
Principles Risk Based Process Safety applied to ICH-Q9 "Risk Assessment"
 
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Protecting people’s lives by reducing incidents drastically. Website: https://www.pharma-chemicalsafety.com Youtube channel: https://www.youtube.com/channel/UCsrjy36NHLKv6ShF30RwLjg Brantford, Ontario: http://www.brantford.ca/Pages/default.aspx More information about process safety management: https://en.wikipedia.org/wiki/Process_safety_management I have worked with major companies in the pharmaceutical, chemical, food and manufacturing industries. Process Safety Management: I have helped organizations to implement and coordinate elements of the process safety management program to prevent outcomes such as fires, explosions or releases to protect the environment and public safety. Health and Safety I have helped companies to develop and implement health and safety programs and strategies to achieve legal compliance and incident reduction locally and internationally. Safety Engineering. I have helped operations to reach safety compliance in various stages of production, starts up operations, and equipment acquisition to comply with safety regulations, codes and standards to prevent the incident and protect employees. Call me today 613-464-0562 to help you to identify all possible hazards of your operations. You can also check PHARMA-CHEMICALSAFETY pages at: Youtube: https://www.youtube.com/channel/UCsrjy36NHLKv6ShF30RwLjg Facebook: https://www.facebook.com/pharmachemicalsafety Twitter: https://www.twitter.com/Pharmachemical1 LinkedIn: https://www.linkedin.com/in/pharmachemicalsafety Google+: https://plus.google.com/u/1/113843293286502571661
Views: 4801 Safefficient 4.0
QbD-Expert™ Software : Video Promo 📽️
 
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🖥 💿 Presenting Promo of - QbD-Expert™(Quality by Design) Software QbD-Expert™, is a World’s First USFDA 21CFR11 Compliant Software Application for Pharma “Quality by Design (QbD)” for designing & development of pharmaceutical dosage forms, offers in built Readymade Modules with Customizable Templates for 150 different pharma formulations comprising of: (A) Solid Orals (Tablets IR / MR, MUPS, Hard Gelatin & SoftGel Capsules), (B) Liquid Orals (Solution, Suspension, Emulsion), (C) Semisolid Externals (Creams, Ointments, Paste, Gels, Jellies), (D) Parenterals (Injections, Infusions, Eye/Ear/Nasal Drops, Aerosols, Lyophilized -Freeze Dried) dosage forms involving 35 different manufacturing processes. With 7 Basic Modules QbD (1. QTPP 2. CQAs 3. RA 4. DoE 5. PAT 6. CS 7. CI) & 21 Advanced Tools of QbD-Expert™, You can design & develop your drug product with implementation of QbD System from Lab scale to Commercial Manufacturing scale with full-fledged Drug Product Development Report. Moreover, After execution of all the batches, each & every component of QbD Modules (QTPP-CQAs- Process Map-Risk Matrix-FMEA-Pareto-CMAs-CPPs-DoE-Design Space-PAT-Scale Up Process Exhibition-Controls-Commercial Validation-Continual Improvement) can be easily exported in HD to MS Word, Excel, Powerpoint & PDF formats which can be easily manageable by R&D Scientists during final Product Dossier Preparation for eCTD ANDA / MAA. For more details you can visit our official website : https://www.qbdexpert.com 📹/📓 For requesting Full Length Video Demo (Practical Exhibition) with QbD-Expert Guide (Theoretical Explanation), you are requested to register your professional details (Department/Faculty, Organization/Institute & Email ID) in below Comment box.
Views: 91 QbD-Expert
Tablet Process Development London
 
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Course objectives This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed. By the end of the course, you will Understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development Understand the relationship between material properties, formulation development and process development Understand the processes commonly used to manufacture tablets and the factors which affect them Recognise how to identify critical processing parameters, and how to incorporate into a process validation program Understand the principles of PAT, how and where it can be most effectively deployed Know the latest FDA thinking on Process Development including the three key steps of validation Who should attend? The course is designed for people new to Process Development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process better. The course will include the latest FDA guidance on the development of generic products under QbD. Course outline: Day 1: Morning - Product development The new regulatory landscape. Q8, Q9 and Q10 and their impact on product and process development Principles of Quality by Design and the product development process Linking material properties to formulation and processing behaviour Workshop session - Understanding Quality by Design Afternoon - Mixing and blending Identifying potential Critical Process Parameters. Use of Process Matrices in process development. Unit processes 1 - Mixing and blending Assessing blend uniformity. Sampling problems and practice Workshop session - blend assessment practical. Effect of material properties on powder mixing behaviour Day 2: Morning - Granulation - wet and dry Why granulation matters - good and bad Critical granulation process parameters and their impact Optimising granulation processes Workshop session - granulation practical. Effect of binder volume on product properties Afternoon - Process Control and Process Analytical Technology (PAT) Principles of process control - feedback and feed forward Use of advanced techniques - limitations and applicability Case studies - what has been done? What is possible? Continuous processing Participants open forum and Question and Answer session. NOTE Wherever possible participants should bring practical problems and examples which can be reviewed on the course. The course will be highly participative and useful for people with or without experience.
Views: 1949 Dipankar Dey
Quality Control- concept, principles, Standards and Specifications
 
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Subject:-Home Science Paper Name: Fashion Designing and Apparel Insdustry
Views: 137 Vidya-mitra
Quality by Design in Clinical Research: Is This Only for the Protocol? Trailer
 
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Over the past few years, Quality by Design (QbD) for clinical trials has been a focus for protocol development and execution. However, even though it is increasingly expected of the industry by regulatory agencies, translating this QbD approach into “building in quality for the business” is rarely shared for the “how do I do this?” This web seminar will de-code and translate QbD and quality for the research enterprise with examples that will solidify the concepts and framework presented for use within any organization. We will discuss the critical first step of defining quality; how to simplify QbD; how QbD and Quality Management Systems (QMS) relate to each other; determining whether your organization has these in place; what the best QbD principles and methods are; how to go beyond plans and create checklists for quality; and, finally, strategies for effective implementation. Case Study: QbD for a CRA Study Management Plan Job Aid: QbD Worksheet
Views: 100 Kathy Barnett
Quality by Design Strategy Meeting Europe 2016
 
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Proventa International is a management consultancy specialising within the Life Sciences sector. We work with leading and most innovative emerging to large Pharmaceutical and Biotechnology organisations worldwide. For our clients regardless of size, we provide a unique way for each and every one of them to engage with peers in the industry in order to combat strategic challenges and benchmark with cutting edge research from expert industry analysts.
Introduction to Six Sigma
 
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White Belt - $10 - http://www.qualitygurus.com/link/sswb/ Yellow Belt - $19 - http://www.qualitygurus.com/link/ssyb19/ Green Belt - $10 - http://www.qualitygurus.com/link/ssgb-half/ Black Belt - $40 - http://www.qualitygurus.com/link/ssbb/ Minitab for Black Belts - $10 - http://www.qualitygurus.com/link/minitab/ Limited time sale. Get one, get all today!
Views: 822370 QualityGurus
Design, Typography & Layout Tips
 
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Is your poster layout working? Want some quick tips and tricks on how to make your design better? Watch Master Chris Do design on the fly to come up with solutions for design problems you might be having. He shows how to break items down into groups and why/where he places elements on the page to enhance the design. Original poster designed by Darian Rosebrook https://darianrosebrook.com/ This video is a cut down from: How To Improve Your Layout and Typography Critique https://www.youtube.com/watch?v=xjAQ5CK4oqg&t=275s ___ This is the Futur of Education— Disrupting the design education paradigm. Want a deeper dive? Typography, Lettering, Sales & Marketing, Social Media and The Business of Design courses available here: https://goo.gl/bRt5qd — Love the content? Become a sustaining member for $5/mo today. https://goo.gl/uKcJ3N Our BOOKLIST: https://goo.gl/onrdxr Kits & Proposals: https://goo.gl/mSjuWQ Visit our website: https://www.thefutur.com FREE resources: https://goo.gl/Qh6gHr — OUR AFFILIATE LINKS* Skillshare: https://goo.gl/YCo2uT Amazon: https://goo.gl/K1bIhg Creative Market: https://goo.gl/g4jlTE — Futur Podcast on iTunes: 🎙 https://itunes.apple.com/us/podcast/the-futur/id1209219220?mt=2 — Connect with us online: https://www.facebook.com/theFuturisHere/ https://twitter.com/thefuturishere https://www.instagram.com/thefuturishere/ — Credits: Executive Producer– Chris Do Host– Chris Do Director– Erica Pead Cinematography– Aaron Szekely, Mark Contreras Editor– Stewart Schuster, Erica Pead Futur Theme Music – Adam Sanborne http://www.adamsanborne.com Annotations– Isaiah Nwukor Typefaces: Futura, Din, Helvetica Neue Futur theme song— Adam Sanborne === *By making a purchase through any of our affiliate links, we receive a very small commission at no extra cost to you. This helps us on our mission to provide quality education to you. Thank you.
Views: 367431 The Futur
IPPCR: Quality Management in Clinical Research
 
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IPPCR: Quality Management in Clinical Research Air date: Monday, February 29, 2016, 5:00:00 PM Category: IPPCR Runtime: 00:57:04 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to http://clinicalcenter.nih.gov/training/training/ippcr1.html Author: Elizabeth Ness, R.N., M.S.N. Permanent link: http://videocast.nih.gov/launch.asp?19521
Views: 3009 nihvcast
StarCraft II Design - Quality of Life, Micro+Macro Streamlining, and Intentional Design
 
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Hey folks, Welcome back to brownbear's Summer of StarCraft! Today's episode five - quality of life features, micro+macro streamlining, and intentional design. If you enjoyed this video, I'd love it if you followed me here and on Twitter and Facebook to receive regular content updates. The relevant links are below. Thank you and see you next time! Thanks, brownbear Facebook: https://www.facebook.com/brownbeargaming Twitter: https://www.twitter.com/brownbear_47 YouTube: https://www.youtube.com/brownbeargaming Twitch: https://www.twitch.tv/grizzlybrownbeargaming Timestamps: -- Quality of Life (QoL) Introduction (0:31) -- Select-All Army (2:06) -- Changes In-Aggregate (4:39) -- JaKaTaK Anecdote (6:00) -- Application to StarCraft II (7:09) -- Banshee Example (8:27) -- Contrast with Macromanagement (11:27) -- Macro Cycle (12:45) -- Intentional Design (14:09) Recommended Readings (by others): -- http://www.teamliquid.net/forum/starcraft-2/520756-a-eulogy-for-the-six-pool (Legacy’s impact on early game aggression) Recommend Readings (by me): -- https://illiteracyhasdownsides.com/2016/09/25/why-mechanics-are-critical-to-real-time-strategy-games/ (mechanics critical to strategic diversity in competitive rts) -- https://illiteracyhasdownsides.com/2016/12/10/racial-balance-in-real-time-strategy-games/ (racial balance in competitive rts) -- https://illiteracyhasdownsides.com/2016/12/01/rts-design-principles-and-protoss-a-call-for-a-new-design-patch/ (protoss design) -- https://illiteracyhasdownsides.com/2016/12/30/starcraft-ii-is-not-a-successor-to-brood-war/ (StarCraft II and Brood War belong to different genres) -- https://illiteracyhasdownsides.com/2017/01/06/exploring-map-design-with-avex/ (map design) -- https://illiteracyhasdownsides.com/2017/04/19/starcraft-ii-csgo-matchmaking-systems/ (matchmaking) -- https://illiteracyhasdownsides.com/2017/01/10/starcraft-broadcasting-and-the-excellence-of-nation-wars/ (starcraft broadcasting and the excellence of nation wars) References: The list of references is too lengthy for YouTube. As a result, I hosted it on my website: http://illiteracyhasdownsides.com/2017/06/03/starcraft-ii-competitive-multiplayer-design-commentary-references
Views: 3145 brownbear
Build Quality Flexible Housing Central Module File 2 BQFH  Design Principles and Erection Sequence
 
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File 2 Erection and Design Advantages Of the passive heated, flexible designed Central Module self build home with its prefabricated components. The vidoe indicates most of the advantages of using the BFQH design. Vidoe is part of four vidoes found on facebook by Mr Peter King,Build Quality
Views: 3 Peter King
Lilly envisions a workplace where Microsoft 365 enables innovation
 
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“Microsoft 365 security features help improve how we meet data privacy and quality requirements. “Security and quality by design” is one of our IT Strategy principles, and the Microsoft Cloud is clearly aligned.” – Mike Meadows, CTO at Lilly Learn more: https://aka.ms/elilillyandcompany
Views: 4415 Microsoft Office 365