SHWETA SAMBRE’s Post

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

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

🏁🖥 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 !🎖

🖥 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 !🎖

CPCI™ Certified Cleaning Validation "Subject Matter Expert" (SME) Training Classes for 2025! CPCI™ is offering our SME Training Class in the Spring and Fall of 2025! Dates for these classes are: May 19th - 23rd https://lnkd.in/eNkM-Jm7 October 13th - 17th https://lnkd.in/ePkqvf-5 Our continuously updated 1 week long SME course provides detailed training (including "hands-on" laboratory experience) in the new Science-based, Risk-based and Statistics-based approaches found in ASTM E3106-17 "Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation" and its 6 associated cleaning standards. The course also includes a FREE copy of CPCI™'s 411 page Textbook "Cleaning Validation - Science, Risk and Statistics-based Approaches". This textbook directly follows the Lecture slides and course outline making it easy to refresh your learning later on. SPECIAL NOTE: SME course now includes instruction on the derivation of Health Based Exposure Limits (HBELs) and the QA review of HBEL Monographs. Students will actually derive the HBELs for the drug products that will be used in the class. Class Size is limited to 8 students per class to allow more "hands-on" time and activities and closer interaction with the instructors. Registration is on a "first come-first served" basis. For more information and to register for one of these courses please go to our webpage: https://lnkd.in/e_Fqh37 We look forward to seeing you there!

🔓 Unlock the secrets of Process Scale-up, Technology Transfer, and modern Process Validation with our comprehensive three-day training course! Our course is designed to not only explain #regulatory requirements, but also provide #practical insights through engaging case studies. What You'll Learn: 🔹 QbD Principles: Master the foundational principles during process development and scale-up. 🔹 Granulation and Tableting: Understand the intricacies of scaling up these processes. 🔹 Technology Transfer: Navigate regulatory requirements, effective planning, and execution. 🔹 Process Validation: Get up to speed with the latest guidance and requirements. 🔹 Process Design Stage: Learn how to ensure product and process quality from the start. 🔹 Process Performance Qualification: Key strategies for successful qualification. 🔹 Continued Process Verification: Techniques for ongoing process assurance. 🔹 Process Risk Assessment: Identify and mitigate risks effectively. 💡 Highlight: Sign up now to take advantage of our Early Bird offer and secure your spot in this #essential training. Elevate your expertise and ensure your processes are robust, compliant, and #efficient! #ProcessDevelopment #TechnologyTransfer #QualityByDesign #SymmetricTraining

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

🚧 GXP GOOD DOCUMENTATION PRACTICES - APPLICATIONS 🚧 ℹ️ Learn: the critical importance of Good Documentation Practices (GDocP) in GxP-regulated industries, focusing on the application of ALCOA+ principles to ensure data integrity across all stages of product development. ℹ️ Experience: the module follows the lifecycle of a fictional product, "Cloac-20", from research to commercial manufacturing, offering practical scenarios, best practices and experience-based knowledge for both paper and electronic records. ⚠️ Whether for onboarding or annual refresher training, this Module is seamlessly deployable on 👉 your LMS 👈 and can be tailored to your company’s exact needs. ✅ DEMO available - contact info@skillpad.com ✅ Additional screenshots and descriptions of the GXP GOOD DOCUMENTATION PRACTICES - APPLICATIONS module here: https://lnkd.in/g_Cf8bxy 👉 Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/eZt4kHw #gxp #alcoa #dataintegrity #records #documentation #pharma #biopharma #apimanufacturing #lifesciences

Excited to have attended the insightful webinar titled "The Latest Updates in GMP" arranged by IPI Academy Academy. A big thank you to the speaker, Mustafa Edik, for sharing his extensive knowledge and providing us with the latest advancements in Good Manufacturing Practices. The session was incredibly informative and will undoubtedly enhance my understanding and application of GMP standards in my professional journey. Looking forward to more such enriching learning experiences! #GMP #ProfessionalDevelopment #IPIacademy #Webinar #ContinuousLearning

🌟 #Quality by Design (QbD) and Root Cause Analysis: A Powerful Combination Quality by Design (QbD) is a well-established approach used in pharmaceuticals, manufacturing, and other industries to ensure product quality throughout its lifecycle. While #QbD isn’t a direct root cause analysis method, it can significantly enhance your approach to identifying and addressing issues. 🔍 How Can QbD Enhance Root Cause Analysis? Define Critical Quality Attributes (CQAs): Start by identifying the key quality characteristics of your product or process. These attributes directly impact safety, efficacy, or performance. Risk Assessment: Use tools like Failure Mode and Effects Analysis (FMEA) or Hazard Analysis and Critical Control Points (HACCP) to assess risks. This helps you pinpoint potential failure modes and their impact. Design of Experiments (DoE): Apply DoE techniques to systematically explore process variables and their effects on CQAs. This can reveal hidden factors affecting quality. Root Cause Analysis (RCA): When issues arise, follow the steps you mentioned (Fishbone Diagram, 5 Whys, and Brainstorming) to identify root causes. QbD principles can guide this analysis. Continuous Improvement: Implement corrective actions based on root cause findings. Monitor and adjust the process iteratively to maintain quality. Remember, QbD complements root cause analysis by emphasizing proactive prevention and robust process design. 🚀 #TUV_Limited