QbD-Expert™’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 !🎖

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

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.

🚀 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

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

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

 #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

😇Certification in GMP (Good Manufacturing Practices) Document Simplification! 📌Good Manufacturing Practices are essential for ensuring the quality and safety of products. 📌 They provide guidelines that help organizations maintain high standards throughout the production process. However, the 📒documentation involved can often be complex and overwhelming. That’s where document simplification comes in. 😇Implementing these best practices can lead to better compliance with regulatory standards, which is vital in the manufacturing sector. 🤗By simplifying documents, we not only make it easier for our teams to follow procedures, but we also help our organization demonstrate transparency and accountability to regulatory bodies. I would love to connect with other professionals interested in #GMP practices, document management, or #qualityassurance. Sharing insights and experiences can help us all improve our practices and stay up-to-date with industry trends. If you have any tips or experiences related to✨️ GMP document simplification, please feel free to share.🤞 Let’s engage in a conversation about how we can work together to enhance our practices! #GoodManufacturingPractices(GMP) #DocumentSimplification #Certification #QualityAssurance #SOPs