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Why is Seeking Validation Toxic?Why is Seeking Validation Toxic? Join "Help Me Rhonda" live as we dive into why seeking validation is actually toxic to your well-being. Discover empowering tips to build your confidence and embrace self-worth. Say goodbye to doubts and start thriving! Don't miss out—tune in now to unlock your potential and live your best life. 🌟💪 #SelfWorth #Empowerment https://lnkd.in/gdDvfMQF

Validation - one of the things most people look for. Am I good enough? do I come across like I can do this? what does she / he think about me? I’ve also observed there is internal and external validation. We feel great when we get external validation - appreciation, recognition and that enables internal validation for the most part. I’ve also been observing that after 22 years of professional experience this still matters to me… it could be my work, the way I present information or the way I speak - I wonder sometimes why is this so important to me… are people getting more power to control what I feel about myself and does that lead to self doubt, anxiety… I’ve not found complete answers to some of my questions but I know for sure - when I’m more self-aware, when I pause, when I take one step at a time, and when I take it easy, I am able to reflect better, and control my emotions towards something much better and eventually that leads to may be a tad bit of less validation these days that I seek. What do you feel about validation?

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‼️WEEKEND REFRESH‼️ Traditional Process Validation VS Digital Process Validation Part I: Traditional Process Validation Part II: Challenges and Opportunities Part III: Digital Process Validation 💠Traditional Process Validation💠 The #FDA defines process validation as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” It involves demonstrating the process is robust, reliable, and capable of consistently delivering products that meet the desired #quality, #safety, and #efficacy standards. ‼️There are three stages of process validation: ✅ Stage 1 – #ProcessDesign: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities. ✅ Stage 2 – #ProcessQualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing. ✅ Stage 3 – #ContinuedProcessVerification: Ongoing assurance is gained during routine production that the process remains in a state of control ➡️PROCESS DESIGN In this stage, #pharmaceuticalmanufacturers define and create a detailed plan for how a #drug or #biologicproduct will be manufactured. The objectives include: 💊 Identifying critical quality attributes (#CQAs): These are the characteristics of a product that are essential to meet its desired quality standards. 💊 Defining critical process parameters (#CPPs): These are the variables in the manufacturing process that can affect the CQAs. Identifying and controlling CPPs is vital to ensuring product consistency and quality. 💊 Developing a detailed process flow: Manufacturers create a step-by-step blueprint of the manufacturing process, including equipment, materials, and operating procedures which will be encompassed in a #MasterBatchRecord (#MBR). 💊 Drafting a #validationmasterplan: This document outlines the overall strategy for process validation, including the scope, resources, responsibilities, and timelines. ➡️ Process Qualification It involves executing the validated process as per the design and ensuring that it consistently delivers products meeting the predefined quality attributes and process parameters. Key components of process qualification may include: 💊 #InstallationQualification (#IQ) 💊 #OperationalQualification (#OQ) 💊 #ProcessPerformanceQualification (#PPQ) ➡️ Continued Process Verification (#CPV). Unlike the previous stages, CPV is an ongoing process that extends beyond the initial qualification. Its objectives include: 💊 Continuous monitoring of the manufacturing process 💊 Data-driven decision-making 💊Risk management If you like this post follow me for Part II #ProcessValidation #compliance #digitalprocessvaludation Credit: ISPE

Celebrating the Engineers Who Make Our Medicines Possible! This Engineer's Week, we're recognizing the incredible engineers who are the backbone of our work at Automated Systems! From optimizing manufacturing processes to developing cutting-edge technologies that improve patient care, our engineers play a critical role in ensuring the quality and accessibility of our medicines. Here's a glimpse into the diverse and impactful work our engineers do: Validation Engineers: Ensuring our manufacturing processes and equipment consistently produce safe and effective medications by conducting rigorous testing and analysis. Automation Engineers: Designing and implementing automated systems that streamline manufacturing and improve efficiency. Chemical Engineers: Designing and optimizing complex processes to safely and efficiently produce high-quality medications. Biomedical Engineers: Developing innovative solutions that improve patient outcomes. Software Engineers: Building sophisticated software systems that manage clinical trials, analyze data, and ensure drug safety. We're grateful for our talented and dedicated engineers, whose passion, expertise, and innovation make a real difference in the lives of patients around the world. Join us in celebrating Engineer's Week by applying to one of our open Engineering jobs! https://lnkd.in/ga5K8s9c #EngineersWeek #ThankYouEngineers #STEM #Pharmaceuticals #Innovation #MakingADifference

‼️WEEKEND REFRESH‼️ Traditional Process Validation VS Digital Process Validation Part I: Traditional Process Validation Part II: Challenges and Opportunities Part III: Digital Process Validation 💠Traditional Process Validation💠 The #FDA defines process validation as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” It involves demonstrating the process is robust, reliable, and capable of consistently delivering products that meet the desired #quality, #safety, and #efficacy standards. ‼️There are three stages of process validation: ✅ Stage 1 – #ProcessDesign: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities. ✅ Stage 2 – #ProcessQualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing. ✅ Stage 3 – #ContinuedProcessVerification: Ongoing assurance is gained during routine production that the process remains in a state of control ➡️PROCESS DESIGN In this stage, #pharmaceuticalmanufacturers define and create a detailed plan for how a #drug or #biologicproduct will be manufactured. The objectives include: 💊 Identifying critical quality attributes (#CQAs): These are the characteristics of a product that are essential to meet its desired quality standards. 💊 Defining critical process parameters (#CPPs): These are the variables in the manufacturing process that can affect the CQAs. Identifying and controlling CPPs is vital to ensuring product consistency and quality. 💊 Developing a detailed process flow: Manufacturers create a step-by-step blueprint of the manufacturing process, including equipment, materials, and operating procedures which will be encompassed in a #MasterBatchRecord (#MBR). 💊 Drafting a #validationmasterplan: This document outlines the overall strategy for process validation, including the scope, resources, responsibilities, and timelines. ➡️ Process Qualification It involves executing the validated process as per the design and ensuring that it consistently delivers products meeting the predefined quality attributes and process parameters. Key components of process qualification may include: 💊 #InstallationQualification (#IQ) 💊 #OperationalQualification (#OQ) 💊 #ProcessPerformanceQualification (#PPQ) ➡️ Continued Process Verification (#CPV). Unlike the previous stages, CPV is an ongoing process that extends beyond the initial qualification. Its objectives include: 💊 Continuous monitoring of the manufacturing process 💊 Data-driven decision-making 💊Risk management If you like this post follow me for Part II #ProcessValidation #compliance #digitalprocessvaludation Credit: ISPE

Verification vs Validation I often see confusion around these two terms. So, let’s break it down. Verification: Checking, Not Assuming Verification is about ensuring we’re following the process. Example → You check the juice's temperature during pasteurization using a thermometer. Why? → It confirms you're heating it as planned, but doesn’t guarantee safety. It’s about doing it right, not proving it works. Validation: Proving, Not Guessing Validation is about proving that what we’re doing works. Example → Research shows that heating juice to a certain temperature kills bacteria. That’s validation in action. Why? → It’s science-backed and ensures your process is effective. Let’s break it down further: 1️⃣ Purpose Verification → Are we following the process? Validation → Does the process achieve safety? 2️⃣ Importance Verification → Keeps us on track with procedures. Validation → Confirms our end product is safe. 3️⃣ Steps For Verification → Set checks (e.g., temp readings). Monitor regularly. Document results. For Validation → Research effectiveness. Test and confirm. Keep records. 4️⃣ Outcome Verification → Process adherence. Validation → Product safety. Verification is about checking. Validation is about proving

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