The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
ERT-01 Evaporation Residue Constant Weight Tester is professionally designed for the precisely quantitative determination of dissolved substances of table wares, containers, packaging films, cans, tubes and other food-use equipments in different soaking solutions.
DELTA XRF Analyzer details: http://bit.ly/MIaAt4
In this presentation, we will show you the DELTA XRF Analyzer's unique labeling feature that streamlines the labeling of alloy material verification tests. It's makes QC inspection and in-service testing simple by providing easy, real time test labeling through an automated and consistent process. This feature is a valuable aid in gathering reliable test data that is critical for accurate PMI testing.
Get a Quote for the DELTA Handheld XRF Analyzer: http://bit.ly/1mqkyuZ
Questions? Contact an Olympus Specialist: http://bit.ly/1hdyGdx
Sign up for our Newsletter: http://bit.ly/1sQqOyj
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
ERT-01 Evaporation Residue Constant Weight Tester is professionally designed for the precisely quantitative determination of dissolved substances of table wares, containers, packaging films, cans, tubes and other food-use equipments in different soaking solutions.
DELTA XRF Analyzer details: http://bit.ly/MIaAt4
In this presentation, we will show you the DELTA XRF Analyzer's unique labeling feature that streamlines the labeling of alloy material verification tests. It's makes QC inspection and in-service testing simple by providing easy, real time test labeling through an automated and consistent process. This feature is a valuable aid in gathering reliable test data that is critical for accurate PMI testing.
Get a Quote for the DELTA Handheld XRF Analyzer: http://bit.ly/1mqkyuZ
Questions? Contact an Olympus Specialist: http://bit.ly/1hdyGdx
Sign up for our Newsletter: http://bit.ly/1sQqOyj
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Integritest® 5 instrument: Integrity assurance with ease and confidenceMilliporeSigma
This data sheet covers how to accurately and reliably verify the integrity of your filters and processing equipment with the portable, easy to implement, and automated Integritest® 5 instrument.
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Attending a job Interview for B1 and B2 Englsih learnersErika906060
It is a sample of an interview for a business english class for pre-intermediate and intermediate english students with emphasis on the speking ability.
3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
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What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
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RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
2. The multi pass test stand is mainly used for testing the performance of
hydraulic filters according to 4548 - 12 and ISO 16889 standards. These
standards describe a method for determining the contaminant capacity,
particle removal and differential pressure characteristics of filter elements are
injected with continuous contaminant (tes dust), whereas online particle
sensors measure the contamination, thus making the evaluation of filter
elements performance possible. This test stand is automatically test report
generated through software controlled by a computer chart and all the test
parameters can be display on the screen. Data handling and generation of reports according to the standards
mentioned above are included.
Multi Pass Test Stand (ISO 4548 - 12)
The test stand is designed as a Multi Pass Test Stand acc. to ISO 4548 - 12 and ISO 16889 as a part of the
filter manufacturing and quality monitoring
Following tests can be performed with this test stand:
?Determination of filtration performance of a filter elements
?Determination of filtration performance of a flat sheet filter media which is optional
?Determination of particle retention ability and contamination holding capacity of a filter element
?Determination of differential pressure characteristics of a filter elements
www.fecproduct.com
The test stand is designed as a Multi Pass Test Stand acc. to ISO 19438 as a part of the filter manufacturing and
quality monitoring center.
Following tests can be performed with this test stand
?Determination of filtration performance of a filter element
?Determination of filtration performance of a flat sheet filter media which is opetional
?Determination of particle retention ability and contamination holding capacity of a filter element
?Determination lf differential pressure characteristics of a element
The multi pass test stand is mainly used for testing the performance of fuel
filters according to ISO 19438 standards. These standard describe a method
for determining the contaminant capacity, particle removal and differential
pressure characteristics of filter elements. In order to determine such
characteristics, filter elements are injected with continuous contaminant,
whereas online particle sensors measure the contamination, thus making the
evaluation of the filter elements performance possible. This test stand is
automatically test report generated through software controlled by a
computer chart and all the test parameters can be displayed on the screen.
Sales Office: 9A, Gurudwara Road, Hari Vihar (Kakraula), Opp. Metro Poll No. 816, New Delhi
110043 (INDIA).
Correspondence Address : Plot No. 35, K-1 Extn, Bank Wali Gali Gurudwara Road, Mohan Garden,
Uttam Nager, Delhi -110059.
Cell - 9811478874, 9811938703, 9212912990
E-mail - Info@fecproduct.com/ inquiry_fec@yahoo.com
Website - www.fecproduct.com