This presentation from IVT's 4th Annual Validation Week Europe provided a thorough explanation of developing a gap analysis, areas in validation that are issues of concern, and FDA expectations of a manufacturer's gap analysis.
Living in a world of amazing competitiveness and constant change, the E-commerce industry is every day challenged to improve the time to market in order to react to customers’ needs and competitor behaviour.
We will talk about at what extent the sprint length impacts time to market.
@AgilePT 2014 - Sprint Length: How to be quicker to marketBruno Cacho
Living in a world of amazing competitiveness and constant change, the E-commerce industry is every day challenged to improve the time to market in order to react to customers’ needs and competitor behavior.
We will talk about at what extent the sprint length impacts time to market.
Plans are worthless. Planning is everything.Dave Rocker
Business expert Dave Rocker shares with you his thoughts on why President Dwight Eisenhower had it right...plans often become worthless but the act of planning can save your company.
What does it take to solve a really hard problem? As we face a world of increasing complexity, the ability to solve the “unsolvable” may be the difference between a surviving culture and a thriving one. Panel Submission Preview for SXSW 2018
The Creative Technologist - Chinaccelerator 8x8 April 8, 2017Neil Liang
The role of a creative technologist as applicable to startups and technology companies in China. This presentation was used in my talk at the Chinaccelerator 8x8 event in Shanghai on April 8, 2017
Living in a world of amazing competitiveness and constant change, the E-commerce industry is every day challenged to improve the time to market in order to react to customers’ needs and competitor behaviour.
We will talk about at what extent the sprint length impacts time to market.
@AgilePT 2014 - Sprint Length: How to be quicker to marketBruno Cacho
Living in a world of amazing competitiveness and constant change, the E-commerce industry is every day challenged to improve the time to market in order to react to customers’ needs and competitor behavior.
We will talk about at what extent the sprint length impacts time to market.
Plans are worthless. Planning is everything.Dave Rocker
Business expert Dave Rocker shares with you his thoughts on why President Dwight Eisenhower had it right...plans often become worthless but the act of planning can save your company.
What does it take to solve a really hard problem? As we face a world of increasing complexity, the ability to solve the “unsolvable” may be the difference between a surviving culture and a thriving one. Panel Submission Preview for SXSW 2018
The Creative Technologist - Chinaccelerator 8x8 April 8, 2017Neil Liang
The role of a creative technologist as applicable to startups and technology companies in China. This presentation was used in my talk at the Chinaccelerator 8x8 event in Shanghai on April 8, 2017
Are we managing Project Right? Openproject reviewDebajit Adhikary
Many a time we have seen that a lot of complex projects are being maintained manually and because of it project leads to failure. To solve the issue here I have discussed Project management software. OpenProject is the leading web-based open source project management software for classical as well as agile project management. It is maintained by an active international community. For more details visit www.debajitadhikary.com/blog
Presentation and workshop, looking at the question "Why still work with PRINCE"?
Part of the Agile Carnival evening, hosted by Agile Holland and LINKIT on February 21st, 2017
Security and Convenience Without CompromiseOneLogin
With a growing number of digital workers, how do you ensure your employees have the best possible working environment without compromising security?
This webinar highlights:
- How to ensure your users have access to the resources they need to be productive
- Tips to help you can stay ahead of any critical risks
Rather, "emerged contexts", these are currents that affect where software testing is heading to and what the impact is to your career.
Talk delivered on February 18, 2016 in the 1st Software Testing Philippines Community Meetup of the year in Infor PSSC, Global City, Taguig, Metro Manila
Note: Slide #17 plays this video https://www.youtube.com/watch?v=L9VBpbnXhWk
Il presidio di Progetto in ambiti AGILI. Presentazione al Congresso SUPSI di Lugano, Giugno 2017. Speakers: Gianluca Bonasegale, Luca Sturaro e Daniele di Lorenzo. Per maggiori dettagli contattare gli speakers oppure il sottoscritto via linkedin.
How to Interview Customers with Square's PMProduct School
Kevin Yien, a Product Manager at Square, talked about how to listen for learnings to influence any decisions you need to make, including: building, marketing and selling a product.
Main points from his talk:
FIND people to interview who will be able to provide valuable feedback
PREPARE scripts for your interviews
CONDUCT discovery interviews to in/validate hypotheses
WRITE actionable notes from interviews (whether in-person or over the phone)
ANALYZE your notes and extract trends/insights
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
Are we managing Project Right? Openproject reviewDebajit Adhikary
Many a time we have seen that a lot of complex projects are being maintained manually and because of it project leads to failure. To solve the issue here I have discussed Project management software. OpenProject is the leading web-based open source project management software for classical as well as agile project management. It is maintained by an active international community. For more details visit www.debajitadhikary.com/blog
Presentation and workshop, looking at the question "Why still work with PRINCE"?
Part of the Agile Carnival evening, hosted by Agile Holland and LINKIT on February 21st, 2017
Security and Convenience Without CompromiseOneLogin
With a growing number of digital workers, how do you ensure your employees have the best possible working environment without compromising security?
This webinar highlights:
- How to ensure your users have access to the resources they need to be productive
- Tips to help you can stay ahead of any critical risks
Rather, "emerged contexts", these are currents that affect where software testing is heading to and what the impact is to your career.
Talk delivered on February 18, 2016 in the 1st Software Testing Philippines Community Meetup of the year in Infor PSSC, Global City, Taguig, Metro Manila
Note: Slide #17 plays this video https://www.youtube.com/watch?v=L9VBpbnXhWk
Il presidio di Progetto in ambiti AGILI. Presentazione al Congresso SUPSI di Lugano, Giugno 2017. Speakers: Gianluca Bonasegale, Luca Sturaro e Daniele di Lorenzo. Per maggiori dettagli contattare gli speakers oppure il sottoscritto via linkedin.
How to Interview Customers with Square's PMProduct School
Kevin Yien, a Product Manager at Square, talked about how to listen for learnings to influence any decisions you need to make, including: building, marketing and selling a product.
Main points from his talk:
FIND people to interview who will be able to provide valuable feedback
PREPARE scripts for your interviews
CONDUCT discovery interviews to in/validate hypotheses
WRITE actionable notes from interviews (whether in-person or over the phone)
ANALYZE your notes and extract trends/insights
This presentation from IVT's 4th Annual reviews what to do when you have an exception, critical vs. non-critical exceptions, and learning how to prevent exceptions.
This presentation from the Institute of Validation Technology's first annual Validation and cGMP Compliance Week Singapore discusses the obstacles to quality such, the key components to improve quality, and the tools for strategic teamwork.
Talent strategy for retaining super talent in the organisation is explained with the help of examples. This can be found in an article in People Matters dated August
Communicating the ROI of UX from The Enterprise to The Streets (JD Buckley at...Rosenfeld Media
JD Buckley: "Communicating the ROI of UX from The Enterprise to The Streets"
Enterprise UX 2018 • June 14-15, 2018 • San Francisco, CA, USA
http://enterpriseux.net
Actionable outputs from capability assessments - project challengeILX Group
Mike Saville, ILX’s Head of Consulting explores how organisations can benefit from combining Best Practice and Organisational Capability Models (including P3m3 v3). This enables leadership teams to answer not only ‘how good are our projects?’, but to establish solutions to persistent problems and build the capability that they need. These themes are illustrated by real-world case studies from multi-national businesses.
Five Tips to Build a High Performance Agile Marketing TeamNicholas Muldoon
Agile Marketing is a rocket ready for lift off! For years software development teams have improved and honed their agile skills helping them deliver more value to their customers more frequently. Delivering more value to your customers, more frequently, is key to scaling your own company.
Learn how marketing teams across the globe are adopting agile practices to deliver campaigns that are more targeted and result in higher engagement. Use these five tips to effectively scale a marketing team to respond to opportunities as they arise, not months after.
Presented on January 30th at the Integrated Marketing Summit 2014 in San Diego.
Introduction of the Agile Digital Enterprise FrameworkPierre E. NEIS
How to respond to Digital Project or Digital Transformation?
The ADE Framework is a lightweight facilitation approach to coherence, engagement to succeed.
Switching horses midstream - From Waterfall to AgileDoc Norton
You’ve been working for several months on a key software initiative for the company and leadership has decided they want it faster than projected, so the team has been told they’re getting “the agile” installed next week.
“Great.”, you think, “Right in the middle of the project. Nothing like changing horses in midstream. One way or another, this will go swimmingly.”
Sarcasm and puns aside, you’ve got a point. It isn’t easy to switch methodologies in the middle of a project. Doc shares some stories from his own experiences helping teams make this change and provides a few pointers that can help you do the same.
While this talk is focused on testing, it involves the whole team, as agile methods usually do.
Improve your ehs performance through budgeting last versionTankou Gildas
This is a presentation I shared last month during a Safety and health meeting. Originally, the ideas are from EHS Today magazine (6 steps for efficicient EHS budgeting). I worked through the idea to make it more relevant for the public background. Personnaly, it improved the way I used to work.
Yard + Cubed - The State of Marketing Planning Whitepaper - Preparing for 2022 Yard Digital
Digital marketing agency Yard partnered with multi-touch attribution vendor Cubed and commissioned a YouGov survey of 1,000 marketing leaders, to determine the state of marketing planning in 2021. Here's a summary of the results and a roadmap to plan and succeed in 2022.
Creating Pay Transparency in the WorkplaceBambooHR
Create pay transparency involves more than publishing employee salaries. This slideshare looks at the different stages of pay transparency and what may be right for your organization.
In this presentation from, Janeen Santorosa discusses the best practices for harmonization of GMP auditing, domestic and international regulations for supplier auditing, integration of risk-based practices, and supplier audit practice tools.
In this presentation from IVT's 4th Annual Validation Week EU, Paul Pluta, discussed the differences between the traditional approach to cleaning validation and the lifecycle approach, applicable regulatory guidance, current industry trends, the necessary phases of the lifecycle approach (design and definition, cycle development, validation, and implementation), how to continously monitor the process, change control, and common obstacles to compliance.
This session from the Institute of Validation Technology's 14th Annual CSV Conference looks at B. Braun’s journey in moving from an in-house validated training tracking system to learning management in the cloud.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
This session from the Institute of Validation Technology's Contamination and Control Week discusses regulatory expectations and industry drivers for aseptic cleaning and environmental monitoring, regulatory expectations for cleanrooms, and current FDA and EU expectations during inspection of sterile and aseptic operations.
In this presentation from the Institute of Validation Technology's Life Sciences Aseptic Processing, Kim Van Antwerpen discusses collecting environmental data, methods for trending, and interpreting and sharing environmental monitoring data.
Regulatory inspections have had a significant impact on the number of drug shortages and companies facing adverse regulatory actions.
Review of the inspection trends can be useful in assessing the regulatory status of your own company and help aid in the preparation for upcoming inspections. This session from IVT's Contamination and Control Week provides an in-depth, practical look at some of the recent Warning Letters and discusses current trends.
The Validation Master Plan is a a valuable opportunity to provide an overview of your company’s validation process, including organization structure, content, and planning.
Regulatory guidelines on stability testing are mainly designed to address studies that will be applied to support NDAs. However, in any pharmaceutical development program, a number of other stability studies are also required, for example, to help select appropriate formulations and to support regulatory applications for clinical programs. This session from the Institute of Validation Technology's Stability Programs Forum outlines a number of examples of early development stability studies.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
This workshop examines the approach to Continued Process Verification and demonstrating that your product and process are operating in a state of control and continue to do so over the life of the product. Without any prior coordination, the theme was elaborated by the afternoon speakers once the conference itself was underway. The concept of “step up step down” for adjusting the level of product scrutiny both for process parameters monitoring and for sampling and testing quality attributes was explored and developed.
In this presentation from IVT's GMP Week, Journal of Validation Technology Editor-in-Chief, Paul Pluta, Ph.D., asks "can compliance be improved by using quality by design [QbD] concepts?" Pluta discussed the QbD application, development of validation master plans, and the lifecycle approach to process validation. Furthermore, he discusses how to incorporate these essential parts of the validation process to implement effective, and efficient, compliance by design into the quality system.
This presentation from IVT's 2nd Annual Validation Week Canada covers the 2011 FDA Process validation and the subsequent statistical processes. Statistics in process validation is introduced as well as the integration with six sigma and solutions to common mistakes.
A comprehensive presentation on GMP systems and integration. This includes validations, vendor qualification, preventative maintenance, audits, CAPA, and utilization of system results.
This presentation from IVT Network's Method Validation Conference covers required and suggested regulations and guidances for biological process specifications. It also covers dosage form considerations and specifications for other components.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
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Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
How to Give Better Lectures: Some Tips for Doctors
Conduct a Gap Analysis of a Validation Programme
1. Conduct a Gap Analysis of a
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4 TH A N N U A L V A L I D A T I O N W E E K E U
20-22 MARCH 2013
COPENHAGEN, DENMARK
DEBORAH S. TURNER
ASSOCIATE DIRECTOR VALIDATION
ALKERMES, PLC
DEBBIE.TURNER@ALKERMES.COM
2. Disclaimer
The thoughts, ideas, suggestions, recommendations, etc.
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endorsed by any company, past or present, that I have
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thought processes and new tools to accomplish those
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processes. Each company and situation is different and
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requires thought about the existing environment and
consideration of all factors before implementation. Any
risk or reward derived from implementing these
processes or tools, positive or negative, is entirely your
own.
4. Getting Acquainted
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1. COMPANY
2. POSITION
3. HOW LONG YOU HAVE BEEN IN THE
INDUSTRY
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PROBLEM, THIS WHOLE CONFERENCE
WILL HAVE BEEN WORTH MY TIME.”
5. Defining “GAP Analysis”
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•H O W D O E S I T D I F F E R F R O M A N A U D I T ?
•W H Y I S I T B E N E F I C I A L ?
6. Preparing for a GAP Analysis
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•U N D E R S T A N D I N G T H E S H A R E H O L D E R S A N D
THEIR REQUIREMENTS
•D E F I N I N G S T A N D A R D S
•T O O L S F O R C O N D U C T I N G A G A P A N A L Y S I S
7. During the GAP Analysis
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•C O M M U N I C A T I O N S
•D E F I N E E X P E C T A T I O N S
•W H A T T O L O O K F O R
8. After the GAP Analysis
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•M E T R I C S
•F I N A L R E P O R T
•I M P L E M E N T I N G I M P R O V E M E N T S A N D
REMEDIAL ACTION PLANS
10. Conduct a Gap Analysis of a
Validation Programme
g
4 TH A N N U A L V A L I D A T I O N W E E K E U
20-22 MARCH 2013
COPENHAGEN, DENMARK
DEBORAH S. TURNER
ASSOCIATE DIRECTOR VALIDATION
ALKERMES, PLC
DEBBIE.TURNER@ALKERMES.COM