This document lists 4 websites: SlideShare.Net for sharing presentations, Zamzar.com for video file conversion, Zoho.com for file sharing, and Bing.com for internet searching.
This webinar describes a 10-step risk-based approach to validating COTS software in order to reduce costs and documentation requirements by up to two-thirds. Attendees will learn how to link requirements, risk management, and testing to efficiently validate computer systems. The speaker is an industry expert who has completed over 200 validation projects and authored a book on risk-based software validation.
The document advertises a live webinar on HIPAA and EHR compliance with new rules. The webinar will discuss recent and proposed changes to HIPAA regulations that impact electronic health records and provide guidance on how to achieve and audit compliance. Attendees include compliance directors, CEOs, and other leadership and IT roles. Individual registration is $189 or a group of up to 10 can register for $499. The webinar speaker is an experienced healthcare compliance consultant.
The Nutriversal Seal of Promise indicates that products have met stringent quality standards and blend sound nutrition with universally appealing ingredients, delivering the finest available food.
Teks tersebut memberikan instruksi lengkap tentang cara merakit komputer pribadi mulai dari persiapan peralatan, pemasangan komponen utama seperti motherboard, processor, RAM, hingga penyambungan kabel dan pengaturan BIOS.
The document discusses Marshall McLuhan's views on electronic media like the telegraph. It provides context on the telegraph's development and impact. According to McLuhan, the telegraph had several key effects: it allowed for instant transmission of information over long distances, it weakened traditional power structures by enabling direct communication across hierarchies, and it fostered interdependence among social institutions. The document examines other media like the telephone and their unintended consequences, noting that new technologies often improve old media before their true effects emerge.
Pengantar Sistem Komunikasi Serat Optik. dalam slide ini menjelaskan mengenai Jenis dan prinsip kerja dari serat optik, frekuensi band, kelemahan - kelebihan serat optik berdasarkan jenisnya, dan penjelasan dasar dari laser.
menjelaskan besar frekuensi dan perhitungan rumus dari dispersi. Total Internal Reflection.
This webinar will provide an overview of design controls for medical devices. It will cover the basics of design controls and how they ensure all requirements are met while not creating barriers to timely market introduction. The webinar will discuss design control requirements at each stage of the design process, including planning, input/output, reviews, documentation, and transfer. It will also cover post-market design control requirements. The speaker is an expert in quality and regulatory compliance for medical devices.
This document lists 4 websites: SlideShare.Net for sharing presentations, Zamzar.com for video file conversion, Zoho.com for file sharing, and Bing.com for internet searching.
This webinar describes a 10-step risk-based approach to validating COTS software in order to reduce costs and documentation requirements by up to two-thirds. Attendees will learn how to link requirements, risk management, and testing to efficiently validate computer systems. The speaker is an industry expert who has completed over 200 validation projects and authored a book on risk-based software validation.
The document advertises a live webinar on HIPAA and EHR compliance with new rules. The webinar will discuss recent and proposed changes to HIPAA regulations that impact electronic health records and provide guidance on how to achieve and audit compliance. Attendees include compliance directors, CEOs, and other leadership and IT roles. Individual registration is $189 or a group of up to 10 can register for $499. The webinar speaker is an experienced healthcare compliance consultant.
The Nutriversal Seal of Promise indicates that products have met stringent quality standards and blend sound nutrition with universally appealing ingredients, delivering the finest available food.
Teks tersebut memberikan instruksi lengkap tentang cara merakit komputer pribadi mulai dari persiapan peralatan, pemasangan komponen utama seperti motherboard, processor, RAM, hingga penyambungan kabel dan pengaturan BIOS.
The document discusses Marshall McLuhan's views on electronic media like the telegraph. It provides context on the telegraph's development and impact. According to McLuhan, the telegraph had several key effects: it allowed for instant transmission of information over long distances, it weakened traditional power structures by enabling direct communication across hierarchies, and it fostered interdependence among social institutions. The document examines other media like the telephone and their unintended consequences, noting that new technologies often improve old media before their true effects emerge.
Pengantar Sistem Komunikasi Serat Optik. dalam slide ini menjelaskan mengenai Jenis dan prinsip kerja dari serat optik, frekuensi band, kelemahan - kelebihan serat optik berdasarkan jenisnya, dan penjelasan dasar dari laser.
menjelaskan besar frekuensi dan perhitungan rumus dari dispersi. Total Internal Reflection.
This webinar will provide an overview of design controls for medical devices. It will cover the basics of design controls and how they ensure all requirements are met while not creating barriers to timely market introduction. The webinar will discuss design control requirements at each stage of the design process, including planning, input/output, reviews, documentation, and transfer. It will also cover post-market design control requirements. The speaker is an expert in quality and regulatory compliance for medical devices.
Voen presentation cherries with movie 2011Franklin Trouw
The document discusses OakSun Rain Cover Systems for protecting cherry and other orchards. Key points include:
- The cover system was invented by Reinhard Vöhringer, a cherry grower seeking a stable, wind-resistant, and affordable cover solution for his orchard.
- The system is based on proven hailnet technology and provides permanent ventilation and storm resistance to regulate temperature and improve plant health and fruit quality.
- OakSun has designed steel structures and mounting clips to adapt the system for Australian conditions, and installations have occurred worldwide over the past 20 years.
The document discusses how the United States is nearing a hyperinflationary great depression due to actions by the Federal Reserve and government that have exacerbated fiscal and economic crises. It argues that while 2014 remains the outer limit, conditions have moved this potential currency catastrophe into closer proximity, with risks of aspects unfolding in the coming months. The document provides background on previous related reports and outlines coming economic difficulties like a collapse in the purchasing power of the dollar and normal commercial activity.
This document discusses tunnel technology for crop protection and cultivation. It provides advantages such as environmental protection, cost effectiveness, crop timing assurance, and protection from weather elements. However, it also notes issues like temperature and humidity control, wind resistance, maintenance needs, and pest and irrigation management. The main challenges are wind damage and climate control. It then discusses ventilation principles and realized projects using venting tunnels for tomatoes, berries, and stone fruits. Technical specifications for venting area and angles in single and multi-bay tunnels are also covered. Finally, it considers options for wind protection and climate control, as well as the advantages and disadvantages of self-ventilating plastics for tunnels.
Marshall McLuhan, the man who coined the term of the "Global village" - when the internet was still far away - was one of the most interesting scholars worldwide. What he has to tell has lost nothing of its relevance - his book "understanding media" could be the key for understanding all those social changes electronic media brought in the last century starting already with the telegraph and radio and the beatnik generation.
For this reason in my opinion, every student of economics, media, sociology, organizational behavoiur etc. should once in his livetime have heard about his thoughts. That was the reason why I concentrated my lecture about business communication (or Public relations) at the fabulous Karlshochschule in Karlsruhe, Germany mainly on that topic - allthough it is really a somewhat strange stuff for a lot of people - but I love it and I hope you will also like it.....
The second part of the presentation is uploaded separately
This webinar teaches how to perform risk assessment in order to reduce time for software testing using a 10-step risk-based approach. Attendees will learn step-by-step instructions for performing and documenting a hazard analysis using templates. They will also have the opportunity to perform their own hazard analysis during the workshop. The speaker is an industry leader in computer system validation and software validation.
The webinar discusses preparing for and handling FDA inspections of clinical research. It covers how to prepare for an FDA inspection, how to respond during one, and possible outcomes like 483 observations or warning letters. The webinar is presented by Lee Truax-Bellows, an experienced regulatory consultant, auditor, and clinical research project manager. Attendees include clinical research managers and staff who want to learn how to properly handle FDA inspections of their research.
The webinar discusses the new HIPAA random audit program and how to prepare for and avoid penalties. It will cover the increased fines for HIPAA violations, the launch of random compliance audits of up to 150 covered entities in 2012, and the key areas the audits will focus on. Attendees will learn what documentation needs to be prepared in advance of an audit, how to stay compliant with changing HIPAA rules, and how to implement policies to reduce risks and penalties. The speaker is an expert in HIPAA compliance services who will provide an in-depth look at the audit process and how to be prepared.
The document announces a live webinar on HIPAA and EHR compliance. It notes that HIPAA enforcement is increasing, with new fines and penalties. The webinar will cover HIPAA audit processes, documentation required for compliance, and how to prepare for an audit. It will also discuss complying with HIPAA regulations, information security best practices, and learning from prior HHS audits and penalties. The speaker is an expert in HIPAA and information privacy and security compliance.
The document announces a webinar on regulatory documents for medical devices, including the Design History File, Device Master Record, Device History Record, and Technical File. The webinar will cover ensuring these documents are accurate, accessible to operators, and contain all required production and testing data. It will take place on February 29, 2012 from 1-2pm EST. Early bird discounts are available using the promo code "CGO15". The speaker is Angela Bazigos, CEO of Touchstone Technologies, with almost 30 years of experience in the life sciences industry.
This webinar discusses developing a compliant and cost-effective document approval, control, and distribution system. It will cover the requirements for document control under the QSR and ISO 13485, describe typical document control systems, and provide a streamlined paper-free process. Attendees will learn how to spend less time preparing and distributing documents while maintaining compliance. The webinar speaker is Jeff Kasoff, who has over 13 years of experience in regulatory affairs and document control.
The document advertises a webinar on HIPAA compliance and electronic health records. It discusses recent changes to HIPAA regulations that expand its scope and increase penalties. The webinar will cover how the new rules impact electronic health records and what systems need to do to maintain compliance, such as tracking all access to patient records. It aims to help attendees understand and meet new HIPAA requirements for adopting electronic records while qualifying for federal incentive programs.
This webinar will discuss how to ensure Excel spreadsheets comply with 21 CFR Part 11 requirements for electronic records and electronic signatures. It will cover FDA recommendations for spreadsheet design, development, and maintenance. Attendees will learn how to validate Excel applications, document requirements, and future compliance trends. The webinar leader Angela Bazigos has nearly 30 years of life sciences experience helping companies achieve regulatory compliance.
This webinar discusses HIPAA compliance and preparing for audits. It covers increased fines for noncompliance, mandatory audits by HHS, and documentation required. Attendees will learn about recent rule changes, audit procedures, and how to develop security policies to meet requirements. The webinar founder has 30 years of healthcare compliance experience and will provide tools and best practices for avoiding penalties.
This document advertises a webinar on Drug Master Files (DMFs) that will discuss DMFs' role in the FDA regulatory approval process for drugs and biologics. The webinar will explain how to prepare and maintain DMFs for different types of products and businesses, how DMFs fit into FDA review processes, and how to avoid common errors. Attendees will learn about DMF requirements in the US as well as other countries like the EU, Japan, Canada, and Australia. The webinar speaker is an expert in global regulatory compliance with over 27 years of experience in the pharmaceutical industry.
This document advertises a live webinar on how to write standard operating procedures (SOPs) and work instructions that meet compliance requirements. The webinar will be held on August 16, 2011 and will provide information on differentiating between SOPs and work instructions, and steps for effectively writing each. Attendees will receive an e-book on the topic. The webinar is aimed at quality managers, engineers, and others in regulated industries. Pricing and registration information is provided.
This webinar discusses establishing a reduced testing program for incoming components in accordance with GMP quality principles and regulations. It will review the reduced testing lifecycle, including specifications, supplier qualification, auditing, and validation. Examples will demonstrate how to design systems to reduce costs while ensuring compliance. Attendees will learn how to qualify suppliers, control specifications, and reduce testing while maintaining quality. The speaker has 30+ years of experience implementing quality systems and will discuss applying quality assurance principles to medical devices and pharmaceuticals.
The document summarizes a live webinar on the regulatory requirements for medical devices in the EU. The webinar will cover the EU directives, guidance documents, CE marking process, and ISO certification programs for medical devices. Attendees will learn about classifying their products, the requirements for marketing medical devices in the EU, and how to comply with standards for quality assurance, clinical investigations, and labeling. The webinar leader has over 27 years of experience in the medical device industry and regulatory compliance.
This document advertises a webinar on Drug Master Files (DMFs) that will discuss DMFs' role in the FDA regulatory approval process for drugs and biologics. The webinar will explain how to prepare and maintain DMFs for different types of products and businesses, how DMFs fit into FDA review processes, and how to avoid common errors. Attendees will learn about DMF requirements in the US as well as other countries like the EU, Japan, Canada, and Australia. The webinar speaker is an expert in global regulatory compliance with over 27 years of experience in the pharmaceutical industry.
This webinar provides instruction on how to design and manage a CAPA system that meets regulatory compliance requirements. Attendees will learn about the CAPA life cycle and documentation requirements. The speaker has over 15 years of experience in quality roles and will discuss how CAPA is frequently cited by regulators and how to design an effective system. Early registration provides a 15% discount for the 60 minute webinar on September 8, 2011.
Voen presentation cherries with movie 2011Franklin Trouw
The document discusses OakSun Rain Cover Systems for protecting cherry and other orchards. Key points include:
- The cover system was invented by Reinhard Vöhringer, a cherry grower seeking a stable, wind-resistant, and affordable cover solution for his orchard.
- The system is based on proven hailnet technology and provides permanent ventilation and storm resistance to regulate temperature and improve plant health and fruit quality.
- OakSun has designed steel structures and mounting clips to adapt the system for Australian conditions, and installations have occurred worldwide over the past 20 years.
The document discusses how the United States is nearing a hyperinflationary great depression due to actions by the Federal Reserve and government that have exacerbated fiscal and economic crises. It argues that while 2014 remains the outer limit, conditions have moved this potential currency catastrophe into closer proximity, with risks of aspects unfolding in the coming months. The document provides background on previous related reports and outlines coming economic difficulties like a collapse in the purchasing power of the dollar and normal commercial activity.
This document discusses tunnel technology for crop protection and cultivation. It provides advantages such as environmental protection, cost effectiveness, crop timing assurance, and protection from weather elements. However, it also notes issues like temperature and humidity control, wind resistance, maintenance needs, and pest and irrigation management. The main challenges are wind damage and climate control. It then discusses ventilation principles and realized projects using venting tunnels for tomatoes, berries, and stone fruits. Technical specifications for venting area and angles in single and multi-bay tunnels are also covered. Finally, it considers options for wind protection and climate control, as well as the advantages and disadvantages of self-ventilating plastics for tunnels.
Marshall McLuhan, the man who coined the term of the "Global village" - when the internet was still far away - was one of the most interesting scholars worldwide. What he has to tell has lost nothing of its relevance - his book "understanding media" could be the key for understanding all those social changes electronic media brought in the last century starting already with the telegraph and radio and the beatnik generation.
For this reason in my opinion, every student of economics, media, sociology, organizational behavoiur etc. should once in his livetime have heard about his thoughts. That was the reason why I concentrated my lecture about business communication (or Public relations) at the fabulous Karlshochschule in Karlsruhe, Germany mainly on that topic - allthough it is really a somewhat strange stuff for a lot of people - but I love it and I hope you will also like it.....
The second part of the presentation is uploaded separately
This webinar teaches how to perform risk assessment in order to reduce time for software testing using a 10-step risk-based approach. Attendees will learn step-by-step instructions for performing and documenting a hazard analysis using templates. They will also have the opportunity to perform their own hazard analysis during the workshop. The speaker is an industry leader in computer system validation and software validation.
The webinar discusses preparing for and handling FDA inspections of clinical research. It covers how to prepare for an FDA inspection, how to respond during one, and possible outcomes like 483 observations or warning letters. The webinar is presented by Lee Truax-Bellows, an experienced regulatory consultant, auditor, and clinical research project manager. Attendees include clinical research managers and staff who want to learn how to properly handle FDA inspections of their research.
The webinar discusses the new HIPAA random audit program and how to prepare for and avoid penalties. It will cover the increased fines for HIPAA violations, the launch of random compliance audits of up to 150 covered entities in 2012, and the key areas the audits will focus on. Attendees will learn what documentation needs to be prepared in advance of an audit, how to stay compliant with changing HIPAA rules, and how to implement policies to reduce risks and penalties. The speaker is an expert in HIPAA compliance services who will provide an in-depth look at the audit process and how to be prepared.
The document announces a live webinar on HIPAA and EHR compliance. It notes that HIPAA enforcement is increasing, with new fines and penalties. The webinar will cover HIPAA audit processes, documentation required for compliance, and how to prepare for an audit. It will also discuss complying with HIPAA regulations, information security best practices, and learning from prior HHS audits and penalties. The speaker is an expert in HIPAA and information privacy and security compliance.
The document announces a webinar on regulatory documents for medical devices, including the Design History File, Device Master Record, Device History Record, and Technical File. The webinar will cover ensuring these documents are accurate, accessible to operators, and contain all required production and testing data. It will take place on February 29, 2012 from 1-2pm EST. Early bird discounts are available using the promo code "CGO15". The speaker is Angela Bazigos, CEO of Touchstone Technologies, with almost 30 years of experience in the life sciences industry.
This webinar discusses developing a compliant and cost-effective document approval, control, and distribution system. It will cover the requirements for document control under the QSR and ISO 13485, describe typical document control systems, and provide a streamlined paper-free process. Attendees will learn how to spend less time preparing and distributing documents while maintaining compliance. The webinar speaker is Jeff Kasoff, who has over 13 years of experience in regulatory affairs and document control.
The document advertises a webinar on HIPAA compliance and electronic health records. It discusses recent changes to HIPAA regulations that expand its scope and increase penalties. The webinar will cover how the new rules impact electronic health records and what systems need to do to maintain compliance, such as tracking all access to patient records. It aims to help attendees understand and meet new HIPAA requirements for adopting electronic records while qualifying for federal incentive programs.
This webinar will discuss how to ensure Excel spreadsheets comply with 21 CFR Part 11 requirements for electronic records and electronic signatures. It will cover FDA recommendations for spreadsheet design, development, and maintenance. Attendees will learn how to validate Excel applications, document requirements, and future compliance trends. The webinar leader Angela Bazigos has nearly 30 years of life sciences experience helping companies achieve regulatory compliance.
This webinar discusses HIPAA compliance and preparing for audits. It covers increased fines for noncompliance, mandatory audits by HHS, and documentation required. Attendees will learn about recent rule changes, audit procedures, and how to develop security policies to meet requirements. The webinar founder has 30 years of healthcare compliance experience and will provide tools and best practices for avoiding penalties.
This document advertises a webinar on Drug Master Files (DMFs) that will discuss DMFs' role in the FDA regulatory approval process for drugs and biologics. The webinar will explain how to prepare and maintain DMFs for different types of products and businesses, how DMFs fit into FDA review processes, and how to avoid common errors. Attendees will learn about DMF requirements in the US as well as other countries like the EU, Japan, Canada, and Australia. The webinar speaker is an expert in global regulatory compliance with over 27 years of experience in the pharmaceutical industry.
This document advertises a live webinar on how to write standard operating procedures (SOPs) and work instructions that meet compliance requirements. The webinar will be held on August 16, 2011 and will provide information on differentiating between SOPs and work instructions, and steps for effectively writing each. Attendees will receive an e-book on the topic. The webinar is aimed at quality managers, engineers, and others in regulated industries. Pricing and registration information is provided.
This webinar discusses establishing a reduced testing program for incoming components in accordance with GMP quality principles and regulations. It will review the reduced testing lifecycle, including specifications, supplier qualification, auditing, and validation. Examples will demonstrate how to design systems to reduce costs while ensuring compliance. Attendees will learn how to qualify suppliers, control specifications, and reduce testing while maintaining quality. The speaker has 30+ years of experience implementing quality systems and will discuss applying quality assurance principles to medical devices and pharmaceuticals.
The document summarizes a live webinar on the regulatory requirements for medical devices in the EU. The webinar will cover the EU directives, guidance documents, CE marking process, and ISO certification programs for medical devices. Attendees will learn about classifying their products, the requirements for marketing medical devices in the EU, and how to comply with standards for quality assurance, clinical investigations, and labeling. The webinar leader has over 27 years of experience in the medical device industry and regulatory compliance.
This document advertises a webinar on Drug Master Files (DMFs) that will discuss DMFs' role in the FDA regulatory approval process for drugs and biologics. The webinar will explain how to prepare and maintain DMFs for different types of products and businesses, how DMFs fit into FDA review processes, and how to avoid common errors. Attendees will learn about DMF requirements in the US as well as other countries like the EU, Japan, Canada, and Australia. The webinar speaker is an expert in global regulatory compliance with over 27 years of experience in the pharmaceutical industry.
This webinar provides instruction on how to design and manage a CAPA system that meets regulatory compliance requirements. Attendees will learn about the CAPA life cycle and documentation requirements. The speaker has over 15 years of experience in quality roles and will discuss how CAPA is frequently cited by regulators and how to design an effective system. Early registration provides a 15% discount for the 60 minute webinar on September 8, 2011.
This webinar discusses the increasing importance and scope of post-market pharmacovigilance trials. It will cover why the FDA is now mandating larger post-approval studies, the design and goals of phase IV trials, and operational strategies for successful studies. Attendees will learn about FDA guidance on risk evaluation and safety monitoring plans for post-market research. The speaker is an expert in clinical research and drug development regulation who will explain new requirements around pharmacovigilance and rare adverse event reporting.
This webinar discusses how to prepare for and host an FDA inspection related to 21 CFR Part 11. Attendees will learn a quick overview of Part 11, how to prepare for an inspection, how to handle an inspection, trends in Part 11 inspections, and what the future may hold. The webinar speaker is an expert in Part 11 with experience in medical devices and quality certifications. Attendees from quality, engineering, management and regulators will benefit from learning how to ensure compliance and manage inspections of electronic records and signatures.
This webinar discusses lyophilization process development and cycle design. It will cover using thermal characterization techniques like DSC and FDM to design optimized freeze-drying cycles. The webinar will discuss designing the freezing, primary drying, annealing if used, and secondary drying steps of a cycle. It is aimed at scientists and quality professionals involved in handling powders and lyophilized products. The speaker is an expert in lyophilization with a PhD focused on changes to biological molecules during freeze-drying.
2011 Webinar on Medical Devices: EU Directives, Guidance Documents, CE Markin...supportc2go
The document summarizes a live webinar on medical device regulations in the EU. The webinar will discuss EU directives, guidance documents, the CE marking process, and ISO certification requirements for commercializing medical devices in Europe. Attendees will learn about classifying devices and the regulatory requirements for approval and marketing in the EU. The webinar leader has over 27 years of experience in medical device regulation in Europe and globally.
Live Webinar on Lyophilization Process Development and Cycle Designsupportc2go
This webinar discusses lyophilization process development and cycle design. It will cover using thermal characterization techniques like DSC and FDM to design optimized freeze-drying cycles. The webinar will discuss designing the freezing, primary drying, annealing if used, and secondary drying steps of a cycle. It is aimed at scientists and quality professionals involved in handling powders and lyophilized products. The speaker is an expert in lyophilization with experience developing formulations and cycles for parenteral products.
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How are Lilac French Bulldogs Beauty Charming the World and Capturing Hearts....Lacey Max
“After being the most listed dog breed in the United States for 31
years in a row, the Labrador Retriever has dropped to second place
in the American Kennel Club's annual survey of the country's most
popular canines. The French Bulldog is the new top dog in the
United States as of 2022. The stylish puppy has ascended the
rankings in rapid time despite having health concerns and limited
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[To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
This PowerPoint compilation offers a comprehensive overview of 20 leading innovation management frameworks and methodologies, selected for their broad applicability across various industries and organizational contexts. These frameworks are valuable resources for a wide range of users, including business professionals, educators, and consultants.
Each framework is presented with visually engaging diagrams and templates, ensuring the content is both informative and appealing. While this compilation is thorough, please note that the slides are intended as supplementary resources and may not be sufficient for standalone instructional purposes.
This compilation is ideal for anyone looking to enhance their understanding of innovation management and drive meaningful change within their organization. Whether you aim to improve product development processes, enhance customer experiences, or drive digital transformation, these frameworks offer valuable insights and tools to help you achieve your goals.
INCLUDED FRAMEWORKS/MODELS:
1. Stanford’s Design Thinking
2. IDEO’s Human-Centered Design
3. Strategyzer’s Business Model Innovation
4. Lean Startup Methodology
5. Agile Innovation Framework
6. Doblin’s Ten Types of Innovation
7. McKinsey’s Three Horizons of Growth
8. Customer Journey Map
9. Christensen’s Disruptive Innovation Theory
10. Blue Ocean Strategy
11. Strategyn’s Jobs-To-Be-Done (JTBD) Framework with Job Map
12. Design Sprint Framework
13. The Double Diamond
14. Lean Six Sigma DMAIC
15. TRIZ Problem-Solving Framework
16. Edward de Bono’s Six Thinking Hats
17. Stage-Gate Model
18. Toyota’s Six Steps of Kaizen
19. Microsoft’s Digital Transformation Framework
20. Design for Six Sigma (DFSS)
To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations
𝐔𝐧𝐯𝐞𝐢𝐥 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐧𝐞𝐫𝐠𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐰𝐢𝐭𝐡 𝐍𝐄𝐖𝐍𝐓𝐈𝐃𝐄’𝐬 𝐋𝐚𝐭𝐞𝐬𝐭 𝐎𝐟𝐟𝐞𝐫𝐢𝐧𝐠𝐬
Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
Part 2 Deep Dive: Navigating the 2024 Slowdownjeffkluth1
Introduction
The global retail industry has weathered numerous storms, with the financial crisis of 2008 serving as a poignant reminder of the sector's resilience and adaptability. However, as we navigate the complex landscape of 2024, retailers face a unique set of challenges that demand innovative strategies and a fundamental shift in mindset. This white paper contrasts the impact of the 2008 recession on the retail sector with the current headwinds retailers are grappling with, while offering a comprehensive roadmap for success in this new paradigm.
Best practices for project execution and deliveryCLIVE MINCHIN
A select set of project management best practices to keep your project on-track, on-cost and aligned to scope. Many firms have don't have the necessary skills, diligence, methods and oversight of their projects; this leads to slippage, higher costs and longer timeframes. Often firms have a history of projects that simply failed to move the needle. These best practices will help your firm avoid these pitfalls but they require fortitude to apply.
The Most Inspiring Entrepreneurs to Follow in 2024.pdfthesiliconleaders
In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
HOW TO START UP A COMPANY A STEP-BY-STEP GUIDE.pdf46adnanshahzad
How to Start Up a Company: A Step-by-Step Guide Starting a company is an exciting adventure that combines creativity, strategy, and hard work. It can seem overwhelming at first, but with the right guidance, anyone can transform a great idea into a successful business. Let's dive into how to start up a company, from the initial spark of an idea to securing funding and launching your startup.
Introduction
Have you ever dreamed of turning your innovative idea into a thriving business? Starting a company involves numerous steps and decisions, but don't worry—we're here to help. Whether you're exploring how to start a startup company or wondering how to start up a small business, this guide will walk you through the process, step by step.
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Taurus Zodiac Sign: Unveiling the Traits, Dates, and Horoscope Insights of th...my Pandit
Dive into the steadfast world of the Taurus Zodiac Sign. Discover the grounded, stable, and logical nature of Taurus individuals, and explore their key personality traits, important dates, and horoscope insights. Learn how the determination and patience of the Taurus sign make them the rock-steady achievers and anchors of the zodiac.
Industrial Tech SW: Category Renewal and CreationChristian Dahlen
Every industrial revolution has created a new set of categories and a new set of players.
Multiple new technologies have emerged, but Samsara and C3.ai are only two companies which have gone public so far.
Manufacturing startups constitute the largest pipeline share of unicorns and IPO candidates in the SF Bay Area, and software startups dominate in Germany.
Zodiac Signs and Food Preferences_ What Your Sign Says About Your Tastemy Pandit
Know what your zodiac sign says about your taste in food! Explore how the 12 zodiac signs influence your culinary preferences with insights from MyPandit. Dive into astrology and flavors!
1. Live Webinar on : Latin America: Regulatory Compliance Requirements for Life Science
Products (Focus: Brazil, Mexico, Argentina) Tuesday, March 20, 2012
duration : 01:00 to 02:30 PM EST
Description
Why Should You Attend:
This course specifically focuses on the overall regulatory
Get 15 % Discount as an early bird
compliance requirements and procedures for
registration. Use Promo Key :
Pharmaceuticals, Medical Devices, Biologics and
CGO15
Combination Products in Latin America. The primary
countries covered will include: Argentina, Brazil and
Who will benefit Mexico. Other countries such asChile, Costa Rica,
Dominican Republic, Panama, Peru and Venezuela will
be discussed. The course will cover topics relating to
• Regulatory personnel whose pre-clinical and clinical requirements, as well as,
responsibilities require knowledge of addressing the structure of the regulatory agencies in
the Latin American regulatory Latin America. Content will include descriptions of the
environment methods by which regulators in the corresponding
agencies process filings and registrations and what is
• Administrative staff responsible for expected in the authorization and dossier maintenance
ensuring compliance with regulatory of licensed products.
filings and overall regulatory
compliance requirements The current regulatory climate in Latin America is
discussed in detail and several examples will be
• QA / QC Personnel provided to illustrate effective compliance procedures
and techniques. Common issues that have caused
difficulties for Life Sciences firms in the region are
• Global Supply Chain personnel
outlined. Course content will explain how Latin
America interacts with and utilizes ICH standards and
• Clinical / Pharma & Device
how they relate with other national regulatory agencies.
personnel
Additionally, participants will learn how personnel can
best address the conflicts, which arise and the best
• Manufacturing personnel
course for resolution.
2. • Global Business Development
personnel
Agenda: (All time in EST)
• Any sales or general management
employee requiring an understanding 1:00 – 2:15 pm Course Delivery
of how regulations and compliance
issues impact the organization 2:15 – 2:30 pm Q&A Session
Areas Covered in the Session:
• Glossary of Terms.
purchase formats
$189 One Dial In - One • Defining the Opportunity.
Attendee
• Country Facts: Argentina, Brazil, Mexico.
$249 One Dial In - Unlimited
• Latin America's Regulatory Structure for the Life Science
attendance (To be arranged in a
Product Industries
Conference room/Meeting room.
Note : Only One Dial In Allowed)
• Mercosur - Southern Common Market.
$289 On Demand (Recording • Beginning Your Company Involvement in Latin America:
available within 48 hrs after the Examples of Country Requirements.
completion of the webinar)
• Registration / Required Country Licenses.
$349 Get Training CD
• Common Fees.
More Trainings • Overview of the Rules Governing Medicinal Products &
Medical Devices.
o Select Examples of:Clinical Trials, GCP, GMP, Specials,
Marketing Authorizations, Product Classifications, Scientific
Advice, Generics Pricing, Patents, Labeling, SPC, Variations,
Manufacturing Licenses, Renewals, Pharmacovigilance,
Orphan Drugs.
3. • Marketing Authorization Processes - Filings &
Registrations.
o Drug vs. Medical Device vs. Biologic vs. Combination
Product.
• Drug Master File (DMF) Use in Latin America Registrations.
• Use of Expert Reports.
• Processing Variations on Licensed Products.
o Variations: Changes to Marketed Products.
o Types of Variations.
o Dossier Maintenance Expectations.
o Changes Concerning Manufacturing Aspects (Product &
Process).
• Labeling & Packaging Leaflet Requirements.
• Orphan Drugs / Rare Diseases.
• Comparing and Contrasting Latin American Procedures vs.
the U.S. FDA.
o Comparison of Processes.
o Agency Interactions.
o Accepted Practices.
4. • How and When to Influence the Regulatory Process.
o Accepted Country Practices.
o Effective Monitoring Activity.
o Association vs. Individual Company Involvement &
Intervention.
• The Regulatory Negotiation Process.
o Effective Approaches.
o The Do's and Don'ts of Regulatory Involvement.
• How to Use Regulations / Regulatory Contacts to Your
Advantage.
o Check-in Procedure.
o Agency Interactions.
o Business Impact Within and Outside Latin America.
o Professionalism in Regulatory Lobbying.
• Resources / Helpful Websites
About Speaker:
Robert J. Russell, is President and CEO of RJR
Consulting, Inc, a leading Global Regulatory Consulting
firm focusing on assisting the Life Science Industry.
Prior to founding the firm in 2000, Mr. Russell had
5. over 27 years of experience in CMC, Global Business
Development and Regulatory Compliance for
pharmaceuticals, biologics, medical devices and
combination products. The company has an office in
Brussels, Belgium where they interact with the
European Commission and the Competent Authorities
across the EU. Country establishment, marketing
authorizations, variations and license renewals are
core competencies of the course director. Mr. Russell
has received a B.S. and M.S.in Chemistry
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