Fleming’s Post

🌍 Cross-Contamination Risk Assessment in Pharma Manufacturing 🌍 Managing multiple APIs in shared facilities? Cross-contamination risks must be reduced to safe levels based on API-specific PDE values. 💡 What You’ll Learn: ✅ Regulatory frameworks (EMA, PIC/S) ✅ Toxicological limits for shared facilities ✅ Comprehensive risk assessment & mitigation strategies ✅ Maintaining an effective QA system 👨🏫 Trainer: Dr. Helmut Vigenschow 🔍 Gain actionable insights to safeguard patients and ensure compliance in multi-purpose plants. 👉 Join us today: https://lnkd.in/efVZ4CyE #PharmaManufacturing #CrossContamination #RiskManagement #GMP

🌍 Cross-Contamination Risk Assessment in Pharma Manufacturing 🌍 Managing multiple APIs in shared facilities? Cross-contamination risks must be reduced to safe levels based on API-specific PDE values. 💡 What You’ll Learn: ✅ Regulatory frameworks (EMA, PIC/S) ✅ Toxicological limits for shared facilities ✅ Comprehensive risk assessment & mitigation strategies ✅ Maintaining an effective QA system 👨🏫 Trainer: Dr. Helmut Vigenschow 🔍 Gain actionable insights to safeguard patients and ensure compliance in multi-purpose plants. 👉 Join us today: https://lnkd.in/gYWNhqU4 #PharmaManufacturing #CrossContamination #RiskManagement #GMP

🌍 Cross-Contamination Risk Assessment in Pharma Manufacturing 🌍 Managing multiple APIs in shared facilities? Cross-contamination risks must be reduced to safe levels based on API-specific PDE values. 💡 What You’ll Learn: ✅ Regulatory frameworks (EMA, PIC/S) ✅ Toxicological limits for shared facilities ✅ Comprehensive risk assessment & mitigation strategies ✅ Maintaining an effective QA system 👨🏫 Trainer: Dr. Helmut Vigenschow 🔍 Gain actionable insights to safeguard patients and ensure compliance in multi-purpose plants. 👉 Join us today: https://lnkd.in/eau3D8jm #PharmaManufacturing #CrossContamination #RiskManagement #GMP

🌍 Cross-Contamination Risk Assessment in Pharma Manufacturing 🌍 Managing multiple APIs in shared facilities? Cross-contamination risks must be reduced to safe levels based on API-specific PDE values. 💡 What You’ll Learn: ✅ Regulatory frameworks (EMA, PIC/S) ✅ Toxicological limits for shared facilities ✅ Comprehensive risk assessment & mitigation strategies ✅ Maintaining an effective QA system 👨🏫 Trainer: Dr. Helmut Vigenschow 🔍 Gain actionable insights to safeguard patients and ensure compliance in multi-purpose plants. 👉 Join us today: https://lnkd.in/ee-i_vJF #PharmaManufacturing #CrossContamination #RiskManagement #GMP

🔍 Master Quality Risk Management with ICH Q9 Guidelines In today’s pharmaceutical industry, maintaining product quality, ensuring patient safety, and meeting regulatory expectations are non-negotiable. 💡 At Pharada, we specialize in delivering tailored QRM training based on ICH Q9 guidelines. Our training programs are designed to empower your teams to: ✅ Identify and mitigate risks proactively ✅ Strengthen decision-making processes ✅ Improve product quality and patient safety ✅ Align operations with international regulatory standards Our in-house training solutions are flexible, practical, and tailored to meet your organization’s unique needs. Whether you’re focused on production, quality assurance, or regulatory compliance, we equip your team with the knowledge and tools to implement effective risk management strategies. 📢 Let’s work together to enhance your quality systems and elevate your approach to risk management. Contact us today to arrange a customized training program! #QualityRiskManagement #QRM #PharmaceuticalTraining #ICHQ9 #RiskManagement #PharmaceuticalExcellence #Compliance #Pharada#GMP #PharmaQuality

ICH Q9 established essential principles and tools for Quality Risk Management (QRM) in the pharmaceutical industry, promoting proactive risk management and continuous improvement. The recent Revision 1 advances this framework by addressing technological advancements and evolving regulatory expectations. Key updates include enhanced clarity and structure for risk assessment and communication, integration of new tools and techniques, and a stronger focus on continuous improvement and regulatory compliance. Revision 1 also emphasizes effective contamination control by offering systematic approaches to identify, assess, and manage risks. By adopting these updated guidelines, companies can improve operational efficiency, strengthen compliance, and enhance product safety and quality, thus fostering a robust culture of risk management and contamination control. By Cody B., Associate Director, Quality, Compliance & Regulatory, CAI

Curious about the ICH guideline Q14 for Analytical Procedure Development? ICH Q14 explains how to develop and maintain analytical procedures for assessing the quality of drug products and substances, and provides a harmonized guideline on analytical method development. This article overviews the role of ICH Q14 and its main elements including Analytical Target Profile (ATP), Lifecycle Management, and Quality Risk Management (QRM).

Situation: Risk Management Plan (RMP) and Safety Issue Task: A recent review of the product’s benefit-risk profile indicates an increase in adverse drug reactions (ADRs) that were previously considered rare. These reactions are serious but not fatal. Your team has updated the RMP, but there are disagreements about whether to implement additional risk minimization measures. Questions: How do you resolve the disagreements within the team regarding additional risk minimization measures? How do you ensure the updated RMP is communicated to regulatory authorities in a timely manner? How will you monitor the effectiveness of the new measures if they are implemented? #QPPV #compliance #RMP #Pharmacovigilance #drugsafety #patientsafety #ADR

Risk analysis’s century old blunder of defining and analyzing risks as events has created the current chaos. For understanding risks, an old universal truth applies. “How things are done is always more important than what happens because what happens depends on what is done.” Risk analysis is about predicting the probability that a risk relationship will produce a risk event. Given the resulting event’s significance, is the probability of the relationship’s outcome acceptable? For a harm producing relationship, is the probability of preventing the harm low enough? For a benefit producing relationship, is the probability of achieving the benefit objective high enough? Simple questions with answers a simple or complex as the relationship’s mechanisms of action. A bad risk is a bad risk relationship with a bad risk mechanism that results in an unacceptable risk consequence. You manage all relationships by changing the mechanisms that drive the relationship. Some current analysis methods get there eventually, but for efficiently understanding a risk, the best place to start the analysis is by identifying and understanding the mechanisms of the risk’s relationship. The first step for fixing Risk Analysis is to view risks as relationships driven by a definition of a risk as “the impact of uncertainty on a mechanism, process, or system that produces an objective.” It might seem like a small change, but it has huge implications when it comes to effectively analyzing and managing risks. #risk #riskanalysis #riskmangement #ich #ichq9 #iso #iso31000 #fda #qrm #pharmaceuticals #biopharmaceuticals #rera #riskbenefitanalysis #riskbenefit #medicaldevicerisks #medicaldevices

Is Your OOS Investigation Process Missing a Critical Step? The Role of Risk Assessment in Driving Accurate Outcomes! Out-of-Specification (OOS) investigations are crucial for maintaining product quality and compliance, but are you fully leveraging the power of risk assessment in your process? Understanding the risks associated with OOS results can transform your investigation approach, leading to more effective and lasting solutions. 1. Identifying High-Risk Areas: Risk assessments help prioritize where to focus your efforts during an OOS investigation. By identifying high-risk areas, such as critical control points or processes prone to variability, your team can direct resources to where they are needed most. For example, if repeated OOS results occur in a high-risk area like sterile filtration, a deeper investigation into equipment integrity and environmental controls may be warranted. 2. Tailoring Corrective Actions: Risk assessment allows for the development of corrective actions that are proportional to the level of risk. If an OOS result poses a significant risk to patient safety, immediate and robust corrective actions should be implemented. Conversely, lower-risk OOS issues may be addressed with more focused, targeted actions. Training your team to understand these nuances is essential for effective problem-solving. 3. Real-World Example: At DEF Pharmaceuticals, risk assessment was integrated into the OOS investigation process after multiple OOS results were traced back to a single raw material supplier. By conducting a thorough risk assessment, the team identified the supplier as a high-risk factor and implemented a supplier audit program. This proactive approach not only resolved the OOS issue but also reduced future risks by ensuring all suppliers met the same rigorous standards. 4. Enhancing Decision-Making: Risk assessments provide a structured way to evaluate potential consequences of different actions during an OOS investigation. By weighing the risks and benefits, your team can make more informed decisions, ensuring that the chosen corrective actions not only address the immediate issue but also prevent recurrence. **How often does your team incorporate risk assessment into OOS investigations? What challenges do you face in balancing risk with operational efficiency? Let’s discuss and learn from each other’s experiences!** #OOSInvestigations #RiskAssessment #QualityControl #PharmaQuality #ContinuousImprovement