Beyond CMC’s Post

🖥 Very Happy to share that QbD-Expert™ successfully completed “Quality by Design (#QbD)” Hands-On Online Practical Training Workshop Worldwide during Q3:Q4 2023-24 ! ➕️⌨️ #Feedback from all the participants was #EXCELLENT as "genuinely this was the best DoE | QbD | SPC Practical Training Workshop We've attended ever. Dr. Shivang has simplified entire complex subjects of #DoE #QbD #SPC into directly easy to apply systematic methodology through his creative presentation skills along with Practical #Case_Studies & entire relevant #Course_Materials (Master Guides - Manuals - Templates - Worksheets - Calculators) on almost all the types of Pharma Products & its Mfg Processes". ➕️🖱 #Participation of each participant in all the basic technical modules of QbD/DoE/SPC was #COMMENDABLE which could be felt & observed by their very active dedicated involvement in all the advanced practical case studies during entire practical workshop. 🔝QbD-Expert™ is wholeheartedly thankful to all the participants worldwide across 13+ countries for their very actice participation. QbD-Expert™ ensures that we will be your lifetime partner towards EXCELLENCE !🎖

🏁🖥 Very Happy to share that recently QbD-Expert™ successfully completed “Quality by Design (#QbD)” Hands-On Online Practical Training Workshop Worldwide during Q3:Q4 2023-24 ! ➕️⌨️ #Feedback from all the participants was #EXCELLENT as "Genuinely this was the best DoE | QbD | SPC Practical Training Workshop We've attended ever. Dr. Shivang Chaudhary 🎲 has simplified entire complex subjects of #DoE #QbD #SPC into directly easy to apply systematic methodology through his creative presentation skills along with Practical #Case_Studies & entire relevant #Course_Materials (Master Guides - Manuals - Templates - Worksheets - Calculators) on almost all the types of Pharma Products & its Mfg Processes". ➕️🖱 #Participation of each participant in all the basic technical modules of QbD/DoE/SPC was #COMMENDABLE which could be felt & observed by their very active dedicated involvement in all the advanced practical case studies during entire practical workshop. 🔝QbD-Expert™ is wholeheartedly thankful to all the participants worldwide across 13+ countries for their very actice participation. QbD-Expert™ ensures that we will be your lifetime partner towards EXCELLENCE !🎖

Did you know that FDA has a Learning Portal for students, academia, and industry? So, no matter what stage you are in your career, or what type of career you have, you can learn about FDA's regulatory, product quality, and safety responsibilities. #fda #continuingeducation #gcp #glp #gmp #gvp

I struggled academically in junior secondary school, particularly with reading comprehension. Reading and comprehending proved to be a difficult course for me, but with brilliant supportive friends surrounding me I began to walk rather than crawl. I recall in JSS 2, out of my friend group, I had a particular friend who took out time to help me prepare for an exam. From this friend, I improved my reading skills and learned valuable techniques like using acronyms to recall important information. This skill has stuck with me, and I'm now a confident reader. In the pharmaceutical industry, acronyms like the 5Ps of Good Manufacturing Practices (GMP) are used from time to time. These 5Ps are crucial for ensuring product quality and consistency. GMP is a comprehensive system that guarantees quality standards throughout a product's lifecycle. The 5Ps stand for: ✍🏼 People: The foundation of a successful GMP implementation. Employees are expected to adhere strictly to the regulations and all production processes. This is ensured by regular GMP training to increase the understanding of their roles, responsibilities, and the importance of their contributions to product quality and safety. Productivity, efficacy and competency can be aided by regular performance assessment. ✍🏼 Products: Clearly defined specifications for all primary materials including raw materials, other components, intermediate and finished products must be available at every production phase. It is essential to adhere to standard methods for manufacturing and packing, testing, sampling, status control, stability studies and records. ✍🏼 Processes: Simple, consistent and properly documented processes should be accessible to all employees. Regular evaluations should be conducted to ensure compliance with the current process and quality standards. ✍🏼 Procedures: A set of guidelines covering all critical processes play a pivotal role in achieving consistent results. Immediate reporting and thorough investigation is done in the occurrence of a deviation from standard procedures. ✍🏼 Premises: It is essential to enhance cleanliness to prevent cross-contamination, accidents or other fatalities. Equipment placement, proper storage, validation and regular calibration are required to ensure their optimal performance thereby producing reliable and consistent results and preventing failure. These components ensure stringent quality control in the pharmaceutical industry. #quality #gmp #5Ps #procedure

I'm excited to share that I have completed the Quality by Design (QbD) course on Udemy. This comprehensive program deepened my understanding of critical concepts such as- Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), risk assessment (RA) techniques including normal operating range (NOR), risk estimarion matrix (REM), Ishikawa digram, failure mode effect analysis (FMEA). I also explored design methodologies, including Design of Experiments (DoE) and Response Surface Plots and application of all those in pharmaceutical industry and research projects. This Course covers all the statistical tools for QbD framework, with industry specialists and experts facilitating quality implementation in various industries. It also familiarizing myself with ICH Q8, Q9, Q10 guidelines. #QualityByDesign #PharmaceuticalDevelopment #DesignofExperiment #Continuousimprovement

Master QbD Implementation with Our Online Training Program ➡️LEARN MORE: https://hubs.ly/Q02KggS90 For those tasked with the exploration or implementation of Quality by Design (QbD) in their organizations, starting on the right footing is crucial. Our accredited training course addresses the gap often found in available guidance documents, providing concrete, actionable methods to ensure success in QbD initiatives. Highlights of the course include: ✔️ Deep dives into product and process understanding, essential for QbD excellence. ✔️ Detailed training on the creation and application of Risk Priority Numbers (RPN) for effective risk management. ✔️ Practical use of simplified factorial analysis and multivariate data analyses, accompanied by efficient software tools, to minimize experimental burden. Upon completion, you will possess a toolbox of options for managing the details of a QbD program, setting the stage for success in their respective fields. Attend LIVE August 22, 2024 and learn and engage with expert Ranjit Barshikar, CEO of QbD International, United Nations Adviser-Geneva #QbD #riskmanagement #rpn #pharmaceuticalindustry #qualitytraining #regulatorycourses #cobblestone #careeranddevelopment #researchanddevelopment

I'm excited to share that I have completed the Quality by Design (QbD) course on Udemy. This comprehensive program deepened my understanding of critical concepts such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs) and risk assessment (RA) techniques including risk estimarion matrix (REM), Ishikawa digram, failure mode effect analysis (FMEA). I also explored design methodologies, including Design of Experiments (DoE) and Response Surface Plots and application of all those in pharmaceutical industry and research projects. while familiarizing myself with ICH Q8, Q9, Q10 guidelines. This knowledge will enhance my ability to contribute effectively to product development and lifecycle management in the pharmaceutical industry. #QualityByDesign #PharmaceuticalDevelopment #ContinuousImprovement #ICH

🚨 TOMORROW!! Join us live at 10am PT on May 23rd for our quarterly webinar showcasing the latest features and capabilities of Kivo GO. We'll be covering... 📄 Multi-document placeholders 📚 Quality curricula ⚠️ Incident workflows 🪄 Reflowing content plans or projects when dates change Hope to see you there! Register: https://lnkd.in/gVTfPr-a #quality #clinical #regulatoryaffairs #regulatoryoperations #qms #etmf #rim #dms #documentmanagement #compliance #dataintegrity #capa #capamanagement #projectmanagement #regulatoryapproval #clinicaltrials #clinicalresearch #lifesciences #pharma #medtech #biotech

Hello Everyone, I am thrilled to announce that officially I have completed the QBD Lean Six Sigma Yellow Belt . In this course I have gained various learnings like Statistical Predictive Models , Statistical Process Control by completing Modules of Level - 1. #pharmacy #yellowbelt #QBD #certificate #pursullence #drugdevelopment

Check out this Educo team training case study where we designed and delivered a bespoke course for a Regulatory Agency. Educo provided CMC Reviewers a structured, in-depth exploration of ICH Quality Guidelines. Reviewers gained a holistic understanding of the critical aspects of product quality by addressing both chemical and biological products and focusing on topics from stability to lifecycle management. Get in touch to learn how we can support you and your team with bespoke training. #educolifesciences #teamtraining