Dr.Girish B V’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 !🎖

Good Laboratory Practice (GLP) is a quality control system that covers the organizational process and conditions of non-clinical laboratory studies assessing chemical and product safety. When choosing a vendor for AI-assisted image analysis in a GLP-compliant environment, a couple of things should be considered:  1. How does the platform support the GLP workflow 2. What are the advantages of a cloud-based platform 3. How to integrate the platform into existing laboratory systems Read more from this blog post written by our Project Owner (CAS), Emilia Lönnberg ▶️ https://hubs.la/Q02D8h2v0

🖥 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 !🎖

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 

During the first few days up to the first month of working in a new lab you are bombarded with Policies, SOPs and Working instructions and MSDS files. How much do you actually ready especially when it comes to the policies? It’s vital that before we sign an acknowledgement of reading we read and most importantly understand the commitment detailed in the policies. If you are not sure be sure to ask questions so that it’s clear. Do not just sign that you agree to the statements in a policy. This not only gives you the knowledge of what the organisation is committed too but what your role in the greater scheme of things are. It will also allow you to become a great practitioner that follows GLP. #policy #SOP #MLS #MT #GT

Recently, the USFDA issued 483 observations highlighting the critical need for thorough and effective written procedures across various companies. What's the issue? Many organizations are finding their procedures to be either incomplete or inadequate for executing essential activities. For instance, consider the test for Solubility: 𝗜𝗻𝗮𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗘𝘅𝗮𝗺𝗽𝗹𝗲: Test name: Solubility (Material property soluble): take I gm in 10 ml. This lacks the clarity and detail required for consistent execution. 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗱 𝗘𝘅𝗮𝗺𝗽𝗹𝗲: Weigh 1 gm of the substance to be examined and transfer it into a volumetric flask or suitable test tube. Add 10 ml of the specified diluent and shake for approximately one minute (ensure the shaking procedure is validated). Observe any undissolved particles against a black or white background. and document your findings. ✓ 𝖶𝗁𝗒 𝖽𝗈𝖾𝗌 𝗍𝗁𝗂𝗌 𝗆𝖺𝗍𝗍𝖾𝗋? Comprehensive and well-defined SOPS (Standard Operating Procedures) are not just regulatory requirements: they are the backbone of quality and compliance in all departments. They ensure that our processes are repeatable, reliable, and reproducible, ultimately safeguarding product integrity and consumer safety. Let's commit to elevating our documentation standards and fostering a culture of quality in every aspect of our operations! #USFDA #StandardOperating_Procedure #SOP #GoodManufacturing_Practices #Quality_Control #LaboratorySafety #ProcessImprovement #Compliance #Efficiency #Documentation #BestPractices #Laboratory_Management #Quality_Assurance #Pharmaceuticals #Manufacturing_Excellence #QualityControl, #QC, #QualityAssurance, #QualityManagement, #QualityStandards, #ProcessControl, #Inspection, #QualityImprovement, #DefectPrevention, #ContinuousImprovement, #SixSigma, #LeanManufacturing, #ISO9001, #QualityMetrics, #QualityAudit

#What_Is_A_VMP? A VMP is a document that details the way a company will operate, who has control over the various aspects of the validation activities, and how production, quality control, and personnel management will be directed. The VMP allows companies to agree upon and document an overall validation strategy, which can be provided to regulators to serve as clear justification for the validation effort. The VMP allows manufacturers to show they are in control of their quality system and focused on quality. Here is the details Guide "How to write an Effective Validation Master Plan"

GLP (Good Laboratory Practices) ▪️Good Laboratory Practices (GLP) set the gold standard for precision and quality assurance in scientific research. ▪️Through standardized protocols, thorough documentation, and stringent quality control, GLP ensures the accuracy and integrity of experimental data. ▪️Adhering to GLP guidelines is paramount for maintaining the credibility and trustworthiness of research findings. #glp #goodlaboratorypractices #standards #accuracy #knowledge

JTBD Theory. What is the, 'job to be done' and what are the anticipated outcomes? Learn more: https://lnkd.in/gxMhdHbK #jtbdtheory #InnovationManagement #ProductDevelopment #jobstobedone #jtbd

I’ve just uploaded my latest presentation on SlideShare: "Quality Management Systems: An Overview" 📊 Aligned with the Good Regulatory Practices (GRP) syllabus, this presentation explores the core principles, regulatory frameworks, and best practices for implementing robust Quality Management Systems (QMS) across industries. Whether you're in pharma, manufacturing, or tech, this comprehensive guide provides actionable insights into maintaining quality, ensuring compliance, and fostering continuous improvement. 🔗 Check it out here: https://lnkd.in/gmAMvMH7 Your feedback and thoughts are always welcome. #GoodRegulatoryPractices #QualityManagement #QMS #RegulatoryGuidelines