How to find a job with Product Development skills

1. Strategic Product Development

This course discusses how companies create new products that customers want while achieving their financial objectives. Learners begin by defining the product strategies necessary to ensure a company’s long-term growth. Learners then explore the different product development processes used by high-tech businesses today, such as Stage-Gate and Lean/Agile techniques. Learners conclude by illustrating the tools to build the high-performance teams that take the development process from concept through product launch. This course can be taken for academic credit as part of CU Boulder’s Master of Engineering in Engineering Management (ME-EM) degree offered on the Coursera platform. The ME-EM is designed to help engineers, scientists, and technical professionals move into leadership and management roles in the engineering and technical sectors. With performance-based admissions and no application process, the ME-EM is ideal for individuals with a broad range of undergraduate education and/or professional experience. Learn more about the ME-EM program at https://www.coursera.org/degrees/me-engineering-management-boulder...

2. Drug Development Product Management

Pharmaceutical and biotech companies are spending years and millions of dollars developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. This specialization will provide you with a 30,000 feet view of the entire process of drug discovery and development. In the first course you will begin with learning how scientists go from selecting a drug discovery target to filing an Initial New Drug application. In the second course you will learn the intricacy of drug development from Phase 0 to Phase 3 clinical trials and filing a New Drug Application. Finally, in the third course, the specialization will provide you an understanding of the complexities in launching new pharmaceutical products, ensuring sales success and patient access. Healthcare in the U.S. is unlike any other developed country, and this third course provides a good overview for anyone wanting to understand how the U.S. market works.\n\nBy the end of the specialization, you will have mastered a better understanding of the process of discovering new drugs. After completing this specialization if you are interested in pursuing a career specializing in drug development and product management you may want to consider exploring our Master of Science in Drug Development & Product Management at ddpm.ucsd.edu...

3. Improving software development productivity

4.3

(299)

What will be in the course:​Personal experience;​How I structured the work in my team;​What my team and I use;​What are the alternatives to my tools;​Which helped speed up development.​What this course will not include:​A huge amount of theory;​Calculations that prove how to design;​Imposing opinions and proving that problems need to be solved only this way and nothing else.​As a result, this course will be useful not only for the technical leader of the development group, but also for managers of different levels, developers and testers.​The topics of the lessons that will be discussed in this course are shown on the slide:​Introductory lesson;​Team and roles in it;​Technical task;​Work planning;​Task management systems;​Architecture;​Version control systems, version accounting;​Codestyle;​Description of the code;​Automatic generation of documentation;​Testing;​Bug life cycle, Bug tracker;​Automatic tests;​Automatic machines and scripts;​Instructions;​Summing up and my results.​For each topic, there will be an explanation of how this innovation in the development process will help increase efficiency.​By efficiency, I mean the following measured parameters:​The number of mechanical errors will decrease;​Development time will be reduced;​The error search time will decrease;​The time to attract a new developer will decrease;​The accuracy of the development forecast and adherence to plans is increased.​And not measurable, which will also get better:​It will become easier to hand over the product to the customer;​Developers' interest will increase.​...

4. Product Development & Systems Engineering

4.6

(3,086)

Product Development & Systems Engineering uses a structured yet flexible approach to provide a holistic, solid foundation to the successful development of complex products or systems. This course will take you step by step through the product life cycle, from conception to design, development, production, deployment, sustainment and disposal. You will learn how the different components of a system interrelate, and how each contributes product accomplishing its missions. Systems engineering terminology, which can so often confuse the newcomer, is presented in an easily digestible form. Video lectures for individual topics will introduce key concepts. This course welcomes anyone who wants to find out how complex products or systems can be developed and implemented successfully. It is relevant to anyone in project management, engineering, quality assurance, product support, operations, management, maintenance and many other areas. No specific background is required, and we welcome learners with all levels of interest and experience. The course aligns closely with ISO/IEC/IEEE 15288:2015 and 29148:2015 - the same standards used by the International Council on Systems Engineering (INCOSE). Therefore, students will be armed with much of the knowledge required to take the INCOSE knowledge exam for Systems Engineering Preparation (SEP) certification. This course covers most of the material from the INCOSE Systems Engineering Handbook 4th edition - and much more!...

5. Product Management & Development Professional Certification

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Welcome to the Product Management & Development Professional CertificationThat assessment helps to employees and companies in internal certification procedures. Its not a course with theory, its exam for certification / assessmentUdemy doesn't provide certificates for exam type of courses yet. You may: Include info about Assessment / Certification to your CV / Linked in (with choosing of RBS as a Educational Provider) after successful finishing of testWrite us with screens of finished tests for getting of MTF type of diplomaplease also provide name/surname at Udemy and your preferred name for diplomaIn case of any questions, or for certificate getting you may write us to email welcome  gtf. pt ot find the contacts at our web site gtf. ptAssessment Description: Product management and development are critical functions within any organization. They involve the creation, launch, and ongoing improvement of products and services to meet customer needs and drive revenue growth. As such, assessing an employee's proficiency in these areas is essential for companies to ensure that their product strategy is on track and aligned with their business goals. A product management and development assessment can help companies identify skill gaps and areas of improvement for their employees, leading to better performance and increased productivity. By measuring an employee's understanding of market trends, customer needs, product development, and product launch strategies, companies can better equip their workforce to deliver products that meet customer demands and stay ahead of competitors. For employees, a product management and development assessment is an opportunity to showcase their skills and knowledge in this critical area. It allows them to demonstrate their understanding of product strategy, market analysis, and development processes, which can lead to career advancement opportunities within their organization. As they gain experience in product management and development, employees can hone their skills and become valuable contributors to their company's success. In addition to career advancement, product management and development topics are also useful for building a successful career. These skills are transferable across industries and can be leveraged to drive innovation, create new products, and launch successful startups. For individuals who are passionate about creating products that solve customer needs, a career in product management and development can be highly rewarding and fulfilling. Overall, a product management and development assessment is a critical tool for companies and employees alike. It allows companies to evaluate their workforce's proficiency in this area, identify areas of improvement, and build a culture of product innovation. For employees, it is an opportunity to showcase their skills, advance their careers, and build a successful future in product management and development. By investing in product management and development assessment, companies can stay ahead of the competition and drive growth and innovation in the market. Linked topics: AssessmentCertificationProduct Management & DevelopmentProduct ManagementProduct DevelopmentProduct managerProductproduct ownerproduct management certificationproduct design...

6. Product and Service Development: Empathy Mapping with Miro

By the end of this project, you will be fluent in identifying and creating Empathy Maps based on persona for new products and services and in deriving opportunities from your analysis, thus generating positive results for your business venture. This project is designed to engage and harness your visionary and exploratory abilities. You will use proven models in strategy and product development with the Miro platform to explore and analyze customer data combined with the development of Empathy Maps. This is an important step for individuals or companies wanting to explore new products or services. We will practice critically examining the developed persona. You will engage in evaluating, through examples and hands-on practice, making decisions on product orientation...

7. Manufacturing Guide for Mechanical Product Development

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(491)

Welcome to the course that will explain Manufacturing from the very basics - "Manufacturing Guide for Product Development". Whether you are an engineer, product developer, emerging entrepreneur, or simply an Android or Java Developer who is intrigued by the world of manufacturing, this course will provide skills that will help you in many aspects of your engineering or non-engineering career. Gain Manufacturing Knowledge without Spending $60,000 in Colleges and Universities Complete overview of modern manufacturing methodsVideo links that demonstrate these manufacturing methods to understand them visuallyAll complex industrial processes explained in the easiest manner; No unnecessary technical terms and jargonsConnection between manufacturing and product developmentUnderstanding of how everyday products are made like bottles, grocery bags, smartphone case, pipes, metal containers etc. Course Summary Sometimes, even engineers who spend 4 years of college learning theories do not know enough about manufacturing. I have spent countless hours learning manufacturing theories and just as many hours practising in the mechanical engineering industry. I have compiled all the juicy and interesting things in this Udemy course while leaving out unnecessary things so this course is all you need. Unlike computer programming, manufacturing and mechanical engineering are hands-on fields. You need to visit machine shops and factories to see the actual physical processes in order to learn properly. But, I have manufacturing-related video links in this course that will allow you to learn everything without having to visit hot and dirty factories. The best thing about this course is that it uses the simplest language and avoids all the technical and unnecessarily complicated wording so you can understand even the most complicated topics with ease. As long as you have passion to learn amazing things, YOU MUST TAKE THIS COURSE. Contents and Overview This course contains over 40 lectures, 2+ hours of contents, and a compilation of the best video demonstrations for each topic discussed. I will cover these topics MaterialsPlastic TypesConcept GenerationCastingMoldingFormingMachiningPowder Processing3D PrintingJoining By the time you complete this course, you will feel very accomplished and look at products around you differently depending on your profession. If you are in engineering, you will be able to make great prototypes for your design projects and have more hands-on skills compared to your other classmates. If you are not in engineering, you will develop a good eye for seeing things in terms of manufacturing. you will be able to see your smartphone or your window frames and think how they must have been made! There is a lot to learn and you will have questions along the way. Feel free to post your questions and ideas onto the discussion board of this course and I will reply with an answer within 48 hours. I encourage students to participate as much as possible...

8. Introduction to Automotive Product Design & development

4.4

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The Automotive product development process is based on he Mechanical design and development process Starting from product planning to Detail DesignThis course will cover the key aspects of these stages and key activities carried out along with major milestonesConcepts coveredConcept of Concurrent engineering and how teams are formed in cross functional setupMajor milestones at each stage The nature of product development and types of product developmentHow concepts are developed and differences between industrial design and engineering design What are ergonomic analyses and H point. Importance in establishing the concept What is Vehicle architecture and types of Vehicle construction and types of Suspension used in different types of vehiclesWhat are vehicle platforms and modular designs. Importance of standardizationActivities in Systems design - Interfaces and Integration of complex systemsActivities in Detail design phase including DFMEA, DVP preparation and Concern resolutionWhat is BOM , PLM and engineering releaseThe Main outcome of the course is to develop a holistic understanding of the whole process from idea to production level design The course is useful for Design engineering aspirants in automotive domain or for anyone interested in gaining insights how automobiles are developed in industry...

9. Engineering Design Process - Product Development

4.5

(76)

In this course, you will learn how to plan, develop, and maintain a physical product according to a systematic method without having to rely on elusive creativity or luck. The content of this course is based on the German Konstruktionslehre (En. Theory of Design) - an engineering methodology established in the 1970s, taught at elite German technical universities and used by many organizations. The premise of this method is to give engineers or product designers the tools and resources to easily break down any technical problem and arrive at an optimal solution that fulfills the customer's needs. Together with Design Sprint, TRIZ and VDI 2221, the German Konstruktionslehre is one of the most commonly applied design methods in the industry. We will start by getting to know the scope and background of modern Product Development Processes, the current trends and challenges that impact the way we work. We will then learn why a systematic approach is best suited for tackling product development and introduce methods that form the basise of our technique. Once this is covered, we will jump into the hands-on part of the course. It starts with gathering the product requirements, formulating its specs, and setting up a solution-neutral, graphical representation of our product's functionality - the Function Structure. It serves as a basis for developing discrete engineering solutions for each functionality and combining them into a working Product Concept. In the next step, we will learn how to transform the Concept into a final product ready to be manufactured, applying rules for simple, clear, and safe design. The resulting Embodiment Design of the product forms a basis for Simulation, CAD modeling, Tolerancing and Dimensioning, and Rapid Prototyping. The last chapter will teach you how to recognize, trigger, and handle Engineering Change Management after the Product release to accommodate changing customers' needs. By the end of this course, you will be able to systematically develop your product idea and design it into a successful product without the risk of getting stuck or arriving at a sub-optimal result...

10. Mechanical design and Product development process

4.2

(604)

Product development is the process through which  a mechanical product is realized from just an idea into a fully detailed entity ready for production. This course is an attempt to cover that process at an introductory level covering all the key concepts, ideas and details from a perspective of a Mechanical design engineer. The course is structured in a way as to build on the product development process step by step. From the way an Idea is generated, incubated, to how a concept is generated, evaluated, how specifications are created and set  towards the system design of a product , followed by a overview of  activities in Detailed design and prototyping. Topics covered: Opportunity identification and product idea generationWhat are customer needs?What are specifications and when are they set ? how are they set?How are concepts generated?How to select and score concepts?Techniques for Generating ideas and conceptsWhat is modularity? and difference between modular designs and integral designsWhat is product architecture  along with the example of a Vehicle architectureImportance of the Engineering drawing in Detail designDesign for X and Design for manufacturing and Assembly Types of prototypes and the purpose of prototypingWhat you will learn from this course?To understand the overall process of product development and develop a Holistic understanding of how products are developedTo learn ways of developing ideas, opportunities for new product developmentTo understand concepts like product architecture, modularity  and Interfaces relating to mechanical design...

11. Introduction to Design Thinking and Product Development

3.9

(315)

Crisp and straight to the point lectures! This course will cover the following topics.· Design thinking- You will learn about the 5 stages of Design thinking process: Empathize, Define, Ideate, Prototype & Test· Challenges faced during successful Product development· Characteristics of Product development· Cost & Duration of product development· Case study on Electronic brakeforce distribution system· Difference between Agile, Design thinking Design sprintAt the end of the course, you will have a good knowledge on Design thinking approach that is carried out in almost all big companies and also the Product development strategies followed in there. In this course, a case study on Electronic brake-force distribution is compared side-by-side with the explained Design thinking and Product Development topics for your easy understanding. Quizes were added to make the course more interactive and fun. What you'll learn· 5 Step design thinking approaches- Empathize, Define, Ideate, Prototype & Test· Characteristics of Product development process· Cost & Duration of product development· Challenges faced during Product development· Industrial Case study on Design thinking (Electronic brake-force distribution system)· Difference between Design thinking, Agile & Design SprintAre there any course requirements or prerequisites?· No prerequisites required. Best for beginners.· 30 mins of free timeWho this course is for:· Students and early professionals who want to know about the Design  Approach and procedure of Product development...

12. 50 Personal Development And Personal Productivity Skills

4.7

(1,142)

Get 50 productivity and self-improvement courses in 1 with this course! Here are just a few of the skills you'll learn: Personal development skills like mindfulness Improve your focus and concentrationGoal settingIncrease motivationProductivity fundamentals like time managementEliminate interruptionsHealthy, growth mindsetsBoosting your efficiencyMobile apps and software tools to boost your focus and productivityOrganizing your work environmentBecome more disciplinedEmail productivityRealize your life purpose to direct your work in the most optimal directionUse the pursuit of your life purpose to get you as motivated as possible and boost your long-term intrinsic motivationThis is a one-of-a-kind productivity course that will change the way you work to become more efficient and productive. LIFELONG BENEFITSYou'll use the productivity and personal development skills in this course for the rest of your life. As you practice these skills, you'll become better and better at using them to improve your life. The productivity skills will help you at work and business, and the personal development skills will help you in every facet of your everyday life! FIND ENDLESS MOTIVATION WITH MINDFULNESS AND GOAL SETTING  Mindfulness is a tremendous personal development skill because through mindfulness, you'll build a stronger relationship with yourself and develop a richer inner life. Understanding your deeper needs will give you the steering with your life. Once you'll understand where to take your life, you'll unlock incredible and long-term motivation. It will all be aided by goal-setting to help you set a clear target towards which to channel your efforts. ORGANIZE AND STRUCTURE YOUR LIFEOnce you know your life's purpose and direction, you'll have the drive to get there as fast as possible. This is where your quality of execution will become important. This course will show you how to use time management to get more organized, and plan your days and weeks to only focus on the highest-priority projects. ATTAIN COMPOUNDING PRODUCTIVITY GAINS! With personal development, you'll get rid of bad habits that hold you back, with mindfulness you'll get a direction for your life, and with the many productivity skills in this courses, you'll increase your daily output by leaps in bounds! Since there are so many productivity skills in this course, as you become better at applying them, you'll grow your productivity exponentially, and accomplish more and more over time! SIGN UP FOR THIS COURSE AND BECOME A PRODUCTIVITY MACHINEYou will learn how to be productive in: Your daily workYour weekly schedulingAnd most importantly, you will learn to choose the right projects to work on in order to take your life in its best and most optimal directionNOTEIn the course, I go over some productivity apps which might ask you for your email address, and some productivity products which are not free. I DO NOT collect any revenue or your emails for myself. I do not benefit from promoting those productivity products/apps. The only reason I recommend them in the course is that I think they will help you achieve the goals of the course. INSTRUCTOR BACKGROUNDI've been an entrepreneur for 15+ years, have coached 1,000+ entrepreneurs in person, taught 700,000+ students, impacted millions of entrepreneurs worldwide creating 6 and 7-figure businesses in the process, and I would love to help you. BONUSES INCLUDED* Lots of extra freebies, downloadable worksheets, and exercises to make the course more interactive and valuable* Personal invitation to my Facebook community after you complete the course* Be entered to get chosen for my student of the month status and have your business featured RESPONSIVE AND CARING INSTRUCTOR: WORLD-CLASS STUDENT SUPPORTIf you have questions, I am here to help! I answer 99% of student questions within 24 hours. Many students tell me that other instructors don't respond. Well, I do because: 1) I care about my students.2) I feel a responsibility to make sure that students get their money's worth from the course. MONEY-BACK GUARANTEE  This productivity course comes with an unconditional, Udemy-backed, 30-day money-back guarantee. This is not just a guarantee, it's my personal promise to you that I will go out of my way to help you boost your productivity just like I've done for thousands of my other students. Invest in your future. Enroll now and become a productivity star...

13. How to Develop a Sound Product Design Portfolio

This class is a primer in putting together a Product Design portfolio I’ll will cover different components that are commonly seen in portfolio and then cover the most important piece - how to succinctly tell the story of your project...

14. New Product Development for Small Businesses and Entrepreneurs

This course is designed to give the foundations of new product development and will focus on the principles and practices of developing new products including product development go-to-market strategy pricing design branding and advertising...

15. New Product Development For Small Businesses and Start-Ups

In this 1 hr 40 mins long project-based course, you will learn about the process of developing a new product for start-up companies, and small and medium-sized enterprises (SMEs). You will learn about idea generation and the evaluation processes in product development by using an idea generation model and online resources like Google Trends and Amazon. You will use methods to evaluate your product concept through market segmentation, growth potential, and the competition to your product. You will also evaluate a supplier and the cost to your product by analyzing component prices and production rates. By the end of this project, you will be able to create a full retrospective plan for the product launch and understand how and why the specifications are done. Note: This course works best for learners who are based in the North America region. We’re currently working on providing the same experience in other regions...

16. AGILE Product Development Playbook: What Is Real Agile?

4.6

(242)

Course DescriptionAt the turn of the century, a new wave began to move through the product delivery Arena. This wave that began as a ripple in 1986, and then entered the arena information technology in 1993, has now become a tidal wave, Sweeping through our businesses. It is known simply by the term Agile. Our major focus within this course is to look at the delivery of products, especially in the arena of Information Technology. In I. T., the agile philosophy is making a world of difference in areas such as commercial off-the-shelf software implementation, software-as-a-service implementation, platform-as-a-service implementation, and infrastructure-as-a-service implementation. Especially, major differences are being seen in the area of custom software development. It does not matter whether you rent, buy, or build software, agile will increase the chances of success greatly. Success in the area of product development is growing faster and faster on an annual basis. In the introduction section of our course, you will see statistics and examples from very credible sources that show these amazing successes. This course will open your eyes to what agile really is. There are many definitions, interpretations, and misconceptions as to what Agile is all about. This course will give you the foundation that you require if knowledge in this area is essential where you are in your business. So sit back and enjoy what you are about to experience. Key Concepts Covered Include: what Agile really is, who uses Agile, history of where Agile started, the Agile Manifesto, where Agile should be used, where Agile should not be used, key organizational requirements for success with Agile, what will cause Agile to fail in your organization, and finally, how to deliver Agile in your organization. Sit back and enjoy what you are about to discover. It will change your life!...

17. Master Pycharm IDE Become a Productive Python developer

4.3

(336)

This bootcamp is for complete beginners and teaches you everything you should know about Pycharm (one of the best IDE's for Python programming). This is not a theoretical course, but instead I will teach you step by step, practically. WHY SHOULD YOU TAKE THIS COURSE?The goal of this course is to make sure you learn how to use Pycharm the right way so that you can become a better and productive Python developer. This course is not a theoretical course, but we will be actually using Pycharm to learn and explore every feature that it has to offer developers. I will be teaching you how can you customize the appearance of the IDE to suite your needsWe will be exploring how you can change themes, move windows around to get the right productive setup for you. We will be learning about how you can use the IDE only with the keyboard without touching the mouse. Do you know you can do things like moving your code around in the editor, moving methods around, collapsing code, etc by just using keyboard shortcuts. We will be learning all those shortcuts. We will be also learning about how can you refactor your code with Pycharm. Pycharm also has features like version control and debugging. We will be exploring how you can work with the version control system like git, how you can do debugging and debug your code with Pycharm in an easy way. Pycharm makes test driven development very easy by having strong integration with testing libraries. We will be exploring how you can do test driven development with Pycharm. This course is designed keeping beginners in mind, we have made sure that each and every concept is clearly explained in an easy to understand manner. So if you have never used Pycharm, don't worry, I am 100% committed to helping you succeed. After completing this course, you will be very comfortable with Pycharm and you will be able to at least double your coding speed. You will become productive and be able to save a lot more time by using all the techniques that we have learned throughout the course. This course is designed keeping beginners in mind, we have made sure that each and every concept is clearly explained in an easy to understand manner. So if you are a beginner, don't worry, I am 100% committed to helping you succeed. GUARANTEEThis course is backed by Udemy's 30-day money-back guarantee. If after taking this course you realize that this is not for you. Please request a refund, I only want satisfied studentsWHAT ARE THE BENEFITS OF THIS COURSE?Learn how to use Pycharm the right way so that you can become a better and productive developerLearn everything about PycharmCustomize the appearance of the IDE by changing themes, moving windows around, etcLearn how to use the IDE with your keyboard without touching the mouseLearn how to move your code around in the coding editorLearn how can you refactor your code with PycharmLearn how can you extract your code to make it more readableLearn how can you change signatures of methods and classes without impacting its usagesLearn how can you use the version control system and the debuggerLearn how Pycharm makes it easy to work with testing frameworks with its strong integrationWHO IS THIS COURSE FOR?Any developer who wants to use Pycharm and be more productiveAny developer or engineer who wants to learn about PycharmSO ARE YOU READY TO GET STARTED?What are you waiting for? Press the BUY NOW button and start the course. See you inside...

18. Qbd: Quality by Design in Pharmaceutical Product Development

4

(65)

Become Certified Professional in Quality by Design (QbD)The certification covers all the statistical tools for QbD framework. The certification features with industry specialists and experts facilitating quality implementation in various industries. QBD implementation can give manufacturers much more confidence in the robustness of their product, potentially increases the efficiency and quality of their development and manufacturing process as well as reduces profit leakages. QbD elements include the following: (QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). This certification will provide insight into the key principles of QbD covering quality risk management and formal experimental design. The certification is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The certification will offer an excellent introduction for those less familiar with QbD and provide those with more experience with QbD, new ideas on how to further implement the QbD programme. The case study based approach in certification programme is designed for working professionals in full time employment who want to update their knowledge and gain required skills and attitude in the area in order to become a certified GMP professional in the domain. This certification is also beneficial for professionals from different streams to help them intensify their knowledge. This is an advanced certification having rigorous case studies based methodology throughout the duration. While quality by design principles have been used to advance product and process quality in industry, and particularly the automotive industry, they have also been adopted by the U. S. Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs. QbD Overview - a US FDA initiative and its advantagesSince the introduction of Quality-by-Design (QbD) concepts, it has been accepted that quality of pharmaceutical products should be designed and built during the manufacturing process. Most of quality problems are related to the way in which a pharmaceutical product was designed. A poor-designed pharmaceutical product will show poor safety and efficacy, no matter how many tests or analyses have been done to verified its quality. Thus, QbD begins with the recognition that quality will not be improved by merely increasing testing of pharmaceutical products. In other words, quality must be built into the product. Quality by Design (QbD) is one of the most important initiative by US FDA. "Pharmaceutical Quality for the 21st Century: A Risk-Based Approach in 2002 by FDA was the first step towards this goal of QbD compliance. Same period FDA issued another guideline on "Process Analytical Technology" (PAT) to guide the Generic Industry about the advantages of PAT in Real Time Release. This was the beginning of the journey towards implementing QbD. The concept is based on enhancement of Process & Product understanding with the help of Risk assessments, identifying Critical Quality Attributes & Critical Process Parameters to be monitored thru right control strategy. Customers are benefitted thru consistency in commercial manufacturing. FDA recommended the implementation since 2013. US FDA initiative on QbDQbD principles have been adopted by the US Food and Drug Administration (FDA) for the discovery, development, and manufacture of drugs. The FDA initiative is outlined in its report "Pharmaceutical Quality for the 21st Century: A Risk-Based Approach (1). FDA has taken this initiative to guide the Pharmaceutical Industry on how to implement the concepts of QbD into its processes. The focus is on quality should be built into a product with an understanding of the product and process by which it is developed and manufactured with understanding risks involved in manufacturing the product and how best to manage those risks. This is improvement is over "Quality by Testing" (QbT), traditional approach, by the Industry. QbD facilitates design of products and processes that enhances the product's Qurity, Efficacy and Safety in the interest of Patients. While QbD will provide design space (DS), the scale-up and commercial manufacturing experience provides knowledge about the process and the interactions of raw materials used therein with excipients. FDA's Process Validation (2) guidance in January 2011 is for companies to continue benefiting from knowledge gained, and continually improve throughout the process lifecycle by making adaptations to assure root causes of manufacturing problems are addressed. International Conference on Harmonization (ICH) Guidelines Working with regulators in the European Union (the European Medicines Agency) and Japan, the US FDA has improved Quality by Design objectives through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH introduced the guidelines: ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System). These ICH guidelines improve understanding to build "Quality by Design" into Formulation development. This will ensure that "Quality Risk Management and Knowledge Management" are used to monitor the lifecycle management that maintain process control and product quality. The difference between QbD for New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) products is most apparent at the first step of the process(4). US FDA defines QbD as "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". QbD is a systematic process to generate Robust processes with the help of Quality Risk Management (ICH Q9). It is important to control the "Variability" of Raw materials as well as in Manufacturing process by identifying Critical Quality Attributes (CQA) / Critical Material Attributes (CMA) and Critical Process Attributes (CPP) through Risk Management process. It helps to have better understanding of Process & Product thus helping Life Cycle Management of the product (LCM) as explained in diagram no.1Elements of QbD1. Quality Target Product Profile (QTPP) that identifies CQAs of the drug product.2. Product design and understanding including the identification of Critical Material Attributes (CMAs).3. Process design and understanding including the identification of Critical Process Parameters (CPPs) and a thorough understanding of scale-up principles, linking CMAs and CPPs to CQAs.4. A control strategy that includes specifications forthe drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process.5. Process capability and continual improvement. Regulatory agencies objectives (7) for QbD initiatives are to:"Encourage early adoption of new technological advances by the pharmaceutical industry. Facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance. Encourage implementation of risk-based approaches that focus both industry and the agency attention on critical areas. Ensure regulatory review and inspection policies are based on state-of-the-art pharmaceutical science. Enhance consistency and coordination of the FDA's drug quality regulatory programs, in part, by integrating enhanced quality systems approaches into the agency's business processes and regulatory policies concerning review and inspection activities". By obtaining increased process & product understanding in order to identify and monitor critical sources of variability helps to achieve Right First Time Performance. Therefore it is essential we shift from Compliance to improved Process & product understanding , which will allow QbD of effective and efficient manufacturing process as well as Real Time Quality Assurance. One of the important goals of QbD is to ensure that all Sources of Variability affecting a process are identified, explained and managed by appropriate measures. This enables the finished medicine to consistently meet its predefined characteristics from the start to achieve "Right first time". QbD focuses on the use of multivariate analysis, often in combination with modern process-analytical chemistry (PAT) methods and knowledge-management tools to enhance the identification and understanding of critical attributes of materials and critical parameters of the manufacturing process. This enhanced understanding of product and process is used to build quality into manufacturing and provide the basis for continuous improvement of products and processes. Knowledge gained through such process and product understanding helps to monitor Life Cycle Management of the product. process & product understanding to support Continual Improvement. Advantages of QbD to the Generic IndustryBetter understanding of the process and the product. Minimum batch failures. Better understanding of risks involved & mitigation. Minimising variations to achieve consistency in manufacturing quality. An enhance QbD approach to pharmaceutical development provides opportunities for more flexible regulatory approaches for example: Manufacturing changes within the approved design space can be without regulatory review or approval. Reduction of post-approval submissions. Greater regulator confidence of robust products. Innovative Process Validation approaches. More drug availability and less recalls from market. Improved yields, lower cost, less investigations, reduced testing, etc. Timely launch of products. Right first time & every time concept. Continuous improvement over the total product life cycle. Real time Release thru PAT implementation. Return on investment / cost savings. More efficient technology transfers. QbD Applications Scope: It can be applied to Drug substance development (ICH Q11); Drug Product (ICH Q8 R2) , Analytical method development. FDA strongly recommends to include QbD elements in ANDA submissions since JanuaryBenefits: Robust product and processesReduce Production lossesReduce deviations and recalls...

19. The Docker for DevOps course: From development to production

4.5

(1,772)

From Docker novice to DevOps expert in 7 hoursHuge update for 2020: Many videos from this course were completely re-recorded to bring everything up to date. All of the Docker content is up to date as well as all of the other technologies we use, such as nginx, Ubuntu, Debian and more! Looking to level up your skills by deploying your own web application? How about furthering your career by picking up years worth of general DevOps skills?Prepare to get excited about Docker (and this course)! Dozens of massive companies are using Docker every day but the awesome thing about Docker is it works incredibly well even for the smallest projects. Nowadays learning about Docker and general DevOps skills is gaining massive momentum in the tech scene. It's similar to how mobile app development was a few years ago. Companies are EXPECTING new developers to manage the full life cycle of their web applications. This means BOTH developing and deploying your apps. Here's your chance to STAY AHEAD OF THE CURVE. The Docker for DevOps course isn't just your run of the mill introduction to Docker course, you can get that info by skimming Docker's website. This course shows you WHAT you can build with Docker and HOW to do it - of course you'll learn the Docker basics along the way! Together we'll walk through developing and deploying a multi-service Flask and Ruby on Rails application (more framework examples will be provided as bonus lectures too). Oh and don't worry, you won't need Flask or Ruby on Rails experience to understand this course. The emphasis is on deploying a web application, not building one. Learning by example is a great way to retain information and learn quickly. The course has a perfect balance between theory and practical material. At the end of the course, you have a working and secured web app with fully automated deployment along with an understanding of how it works. This is exactly what I wanted from the course. Ready to level up?Here's what you'll get when you sign up to my course today: You'll learn how to get your development environment set up to run Docker. Windows, Mac and Linux users will be able to follow along. Next, you'll learn the Docker basics and we'll complete a hello world example. You'll Dockerize a Flask or Ruby on Rails application and pickup a few best practices on how to create a production ready application with those frameworks. You'll learn how to create a staging server so you can test your app. You'll learn how to keep your app running forever by getting a crash course with systemd. You'll learn how to configure and serve your app over SSL (HTTPS) with nginx. You'll get $10 in free hosting credits on DigitalOcean to deploy your application. You'll learn how to purchase and configure a domain name (and make it work with your new server). Finally, you'll learn how to obtain a FREE SSL certificate and hook it up. I'll also give you tips on where to go next for topics such as: Adding more services to your appScaling out beyond 1 hostMonitoring and alertingHooking up a continuous integration pipelineDealing with centralized loggingLooking into using various configuration management toolsYou're getting all of that AND additional bonus lectures for just $25. This course is jam packed with over 100 lectures, 7+ hours of videos and quizzes. You'll also receive full PDF text directions for each video lecture and complete source code examples. This course was really well put together and covers a wide range of topics around both DevOps and Docker. I chose it primarily for the Docker side, but learned a lot about Ruby and Python too. I am very pleased with this course. Why is it worth using Docker?Saves a ton of time and headaches when setting up development environments. Easily move an application across environments or servers. Removes issues such as well, it worked on my machine!. Makes developing with teams a much more pleasant experience. Works on most major platforms. Has amazing support on most cloud hosting providers. You won't need expensive hosting to deploy your web applications. Docker as a company is well funded and moving forward quickly. Well structured course with high quality information. Source code is really well written and well structured. The tutor support is like 24/7. He replied to my all questions within few hours and most of the times in few minutes. Why is this course for you?After finishing this course you'll have enough knowledge about Docker and general DevOps skills to start applying for jobs, so by investing in this course you're jump starting your DevOps career. Or perhaps you have a thirst to broaden your skill set and want to save a ton of time by avoiding the tedious task of researching all of these topics on your own. In either case, you're going to walk away with years of knowledge and best practices that I've accumulated while working as a consultant. Meticulous hands-on descriptions and recipes of how to utilize Docker and a lot of associated software in the real world scenario of building a web-app! I especially enjoyed the clear delivery of content: well structured, superbly produced, written summaries for each shown topic. Who am I?Hi, I'm Nick. I'm a consultant by day and open source contributor by night. I write software and help companies being their ideas to life. I love learning new things and then sharing my knowledge with others. I don't have a fancy degree but I do have experience shipping code and explaining my thought process to others while I talk about various technical topics...