Dr. Shivang Chaudhary 🎲’s Post

🏁🖥 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 !🎖

Product characterization is the deep analysis we run to learn of the properties that are not readily available to us in routine testing. These characteristics are often critical for ensuring product quality and performance, and serve as guiding stars when making changes along the way, and establishing the Critical Quality Attributes. In Session 3.1 of the CMC Essentials Training Course, we discuss more about the importance of product characterization, and when we do these efforts during development. Now available on-demand- more details here: https://lnkd.in/dqEBvvu7

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

At mdi, quality is integral to every step of our process. That is why we embrace Quality by Design (QbD) in our product development and manufacturing. QbD is a proactive approach that ensures high quality outcomes through statistical, analytical, and risk-management methodologies during design, development, and manufacturing phases. A key goal of QbD is to identify, explain, and manage all Quality Target Product Profiles, Critical Process Parameters, Critical Quality Attributes, variability, and mitigate risks at every stage. QbD allows us to build quality into our products from the start rather than relying solely on end-product testing. QbD also guarantees that the final products consistently meet predefined specifications. At mdi, exceeding expectations is our mission, and QbD is fundamental to that commitment. It is also a powerful tool to drive innovation.   Want to learn more about how mdi leverages QbD? Check out our blog article for an in-depth exploration: https://lnkd.in/ghC83t2A #QbD #innovationwithmdi

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

Joseph Juran, the originator of QbD, distinguished “quality improvement” from “quality planning”: Lets understand Quality By Design improvement is concerned with solving existing problems; planning is concerned with shutting down the hatchery that creates those problems in the first place. In the pharma industry, we know QbD as a systematic approach to development that starts with predefined objectives, and emphasizes product and process understanding, as well as process control based on sound science and risk management. The DFSS methodology and toolbox fits neatly into the QbD framework of developing robust products with good process understanding 

🚀 Thrilled to announce that I've completed an intensive course on Corrective and Preventative Action (CAPA) and 8D Problem Solving on Udemy! Mastering CAPA: A Crucial Skill in Quality Management This course has significantly deepened my expertise in CAPA systems, an essential framework in the medical and pharmaceutical industries for ensuring product and process quality. Key Highlights and Skills Acquired: CAPA Mastery: Gained in-depth knowledge of each step in the CAPA process, from identifying and analyzing problems to implementing effective solutions and preventive measures. Root Cause Analysis (RCA) Tools: Developed skills to create and utilize RCA tools such as Fishbone Diagrams, Pareto Charts 📊, Five Whys, Process Maps, and Fault Tree Analysis. Continuous Improvement: Learned to apply Lean Six Sigma methodologies, including DMAIC and PDCA cycles, to drive continuous improvement and operational excellence. Differentiating CAPA and Non-Conformance: Acquired the ability to distinguish between CAPA and non-conformance, ensuring appropriate actions based on the level of risk each failure presents. Integration with GMP: Understood the critical role of CAPA in maintaining Good Manufacturing Practices (GMP) 🏭 and ensuring compliance in regulated industries. Having completed my master's in Regulatory Affairs, I am excited to apply these new skills in the regulatory field. This certification complements my academic background and prepares me to excel in roles focused on regulatory compliance and quality management, such as Regulatory Affairs Specialist, Regulatory Compliance Manager, or Quality Assurance Specialist. The knowledge and skills gained will enable me to contribute effectively to quality management and regulatory compliance. With lifetime access to the course material, I am committed to continuously honing these skills to stay at the forefront of quality management. #CAPA #QualityManagement #RegulatoryAffairs #ContinuousImprovement #LeanSixSigma #RootCauseAnalysis #GMP #MedicalDevices #PharmaceuticalIndustry #ProfessionalDevelopment

Thing that really matters.... It is the small things that are important in life and same applies to the minor components in the formulation and analytical methods that play a critical role in determining the functionality of products as well analytical results. Many a time we ignore these small things and it leads to recurring product and method failures. For these reasons, the AQbD &QbD approach is a statistical and systematic way of doing the product development and analytical method development. We at QDraft services can assist you in accomplishing the same.

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

Certificate achieved on the completion of course "Introduction to Good Manufacturing Practices (GMP)" This course had extensive and knowledgeable presentations on how Good Manufacturing Practice (GMP) ensures the quality and safety of products by outlining a system of procedures, documentation, and controls for manufacturing processes. #certificate #pharmacist #pharmuni #pharmd #student #pharmaceuticalindustry