How to find a job with Quality Products skills

1. Advanced Product Quality Planning (APQP)

4.2

(60)

Advanced Product Quality Planning (APQP) is a framework that helps manufacturing organizations develop and implement a structured approach to ensure that their products meet customer needs and expectations while also adhering to relevant industry standards and regulations. The APQP process involves a series of stages, including planning, design and development, process validation, and ongoing production monitoring, which are all designed to minimize the risks of product defects, reduce waste and rework, and ultimately improve the quality and reliability of the product. The benefits of APQP include: Improved quality and reliability: By following a structured approach to product development and validation, organizations can identify and mitigate potential quality issues before they arise, resulting in fewer defects and higher overall product reliability. Better collaboration and communication: APQP emphasizes collaboration and communication between different functional areas within an organization, including engineering, manufacturing, and quality control. This helps to ensure that everyone is aligned around the same goals and priorities and can work together more effectively to achieve them. Greater efficiency and cost savings: By identifying potential quality issues early in the development process, organizations can avoid costly rework and production delays. Additionally, by optimizing the manufacturing process and reducing waste, organizations can achieve cost savings and improve their bottom line. Compliance with industry standards and regulations: APQP helps organizations to ensure that their products meet relevant industry standards and regulations, reducing the risk of legal and reputational damage. In this course, students will learn: Standard practices and approaches to the APQP processThe connections between APQP and cost of qualityThe three levels of APQP. the major positions within the supply chain that use APQPWho is using APQP and whyThe personality attributes of a successful APQP leaderThe 6 stages of the APQP process and the major tools used at eachThe general launch progressionThe launch management levelsA comparison of APQP modelsAnd much more! APQP helps manufacturing organizations improve the quality and reliability of their products, reduce costs, and enhance customer satisfaction, positioning them for long-term success in a competitive marketplace. And manufacturing professionals who effectively use and understand the APQP process also position themselves for greater career growth, promotion and opportunity. This course is far more than an academic approach to APQP. But instead, this course is taught by seasoned manufacturing professionals who have used APQP to launch hundred of new products across multiple industries and processes. Plus, when you purchase this course, you get two major benefits in addition to the course material: Lifetime access to the course materials. No limits to when you start the course or how long you have access to it. Answers to your course-related questions through Udemy's messaging system by industry professionals. So if you are looking to gain critical skills to advance your career, THIS IS THE CLASS FOR YOU!! Sign up today!...

2. Design of Experiments for Product, Process & Quality Manager

4.5

(176)

Structured Experimentation or Design of Experiment (DOE) helps Product Engineers to develop and refine designs. It is simply  not possible to develop optimal designs that deliver right product  performance without understanding the relationship between dependent and  independent factors (& within independent factors). Unstructured  experimentation consumes indefinite resources and time, that no  organizations have. This is true for both Engineering Product Managers and Service Product Managers. Similarly, both Engineering and Service Process Managers cannot optimize process parameters or design products without conducting structured experiments. Quality Managers have to constantly improve the quality of product, its  reliability and that cannot happen without improvising design in a structured manner. As a part of DMAIC or DFSS improvement projects, Lean Six Sigma Black Belts & Lean Six Sigma Green Belts are expected to find ways to improve the process and optimize it and it would not be possible with knowledge of structured experimentation (Design of Experiments - DOE)This course is going to help Product and Process Engineering Managers from both Service & Engineering Sectors  to learn DOE from scratch. Practical Knowledge of DOE is non-negotiable for any Product, Process, Quality Managers & Lean Six Sigma Black Belts. Target Audience: Product ManagersProcess ManagersQuality ManagersLean Six Sigma Black Belts What you will accomplish after completing this course: After completing the course you will be able to plan, set up, perform and  analyze Full Factorial, Fractional Factorial and Taguchi DOEWhat is Covered: Structured ExperimentsTypes of ExperimentsPhases of ExperimentsTerms used in DOEFull Factorial Experiment (Performing & Analyzing)Fractional Factorial Experiment (Performing & Analyzing)Taguchi Designs (Performing & Analyzing)...

3. 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...