AGON’s Post

☝ Within the regulatory framework of the pharmaceutical industry, GxP regulations are fundamental as they encompass a set of good practices applied throughout the entire production chain of drugs and cosmetics. The implementation of standards such as GLP (Good Laboratory Practices), GCP (Good Clinical Practices), GDP (Good Distribution Practices) and GMP (Good Manufacturing Practices) throughout the supply chain is crucial because it guarantees an adequate level of quality and safety for patients or consumers. At Verázial we understand the importance of complying with GxP regulations to ensure product quality and safety. Contact us to learn how with our biometric solutions we can help you comply with these regulations regarding data integrity! 💡✅ www.verazial.com #Pharmaceutical Industry #GxPRegulations #Quality #Security.

🔍 Dive into Regulatory Excellence in Pharmaceutical Manufacturing! 📚 Day 1: Unveiling the Essentials of MAH Responsibilities & Regulatory Compliance. Explore the intricacies of MAH obligations as outlined in the EMA "Reflection Paper" and integrated into EU GMP Guide Part III. Understand the crucial role of regulatory compliance throughout the product life cycle, from submission to post-approval activities. 🔬 Day 2: Navigating the Terrain of Development, Manufacturing, and Control Strategies. Delve into the nuances of development, manufacturing, and control strategies ensuring conformity with regulatory standards. Gain insights into stability monitoring, verification activities, and the holistic approach to pharmaceutical life cycle management. 📧 For a detailed agenda, reach out to us at [email protected] or 📞 1 657 452 8174. Don't miss this opportunity to elevate your understanding of pharmaceutical regulatory excellence! #RegulatoryCompliance #GMPGuidelines #MAHResponsibilities #QualityControl #PharmaceuticalManufacturing #LifecycleManagement #QualityByDesign #HealthcareRegulations #PharmaInsights #DrugSafety #OnlineLearning

🌟 Greetings from Pharma Compliance Professionals! 🌟 With years of industry experience under our belt, we extend a warm welcome to our valued network. Follow us for current insights, regulatory expertise, and enduring partnerships in pharmaceutical compliance. Here's to our continued journey toward compliance excellence! #SeasonedPros #PharmaCompliance

Embark on a journey of regulatory compliance and pharmacovigilance excellence with us! Our dedicated team ensures the safety and efficacy of pharmaceutical products, paving the path for a healthier future. Trust in our expertise for comprehensive solutions that prioritize safety, innovation, and regulatory compliance. 💊✨ #RegulatoryLeaders #PharmaSafety #InnovateWithConfidence #PharmaRegulation #DrugSafety #ComplianceMatters #HealthcareCompliance #RegulatoryExperts #QualityAssurance #PatientSafety #RegulatoryAffairs #DrugDevelopment #PharmaConsulting #RegulatoryCompliance #RegulatoryCompliance #RegulatoryInsights #PharmaIndustry #GlobalRegulations

# New guidance from FDA on Off-The-Shelf Software Use in Medical Devices Released on August 2023 The guidance document provides information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf (OTS) software used in a medical device. #csv #computersystemvalidation #csa #pharmaceutical #pharmamanufacturing #pharmaceuticals #pharma #pharmaceuticalindustry #gamp #gamp5 #gxp #gmp #glp #validation #validate #computersystems #audit #auditingservices #auditmanagement #compliance #quality #ask #pharmaceuticals #pharmaceuticalindustry #management #pharmamanufacturing #sterile # #planning #execution #reports #21cfrpart11 #csv #csa #computersystemvalidation #pharma #clients #customerexperience #fda #regulatory #regulatorycompliance #regulations

🔍📊 Exciting Discussion Alert! 📊🔍 Are you familiar with the differences between 21 CFR PART 11 and #EU #GMP Annex 11 in the pharmaceutical industry? Join us as we delve into the intricacies of these regulations and explore their impact on data management in the sector. 💊💻 FREE DOWNLOAD This valuable #Presentation in #Pharma and #medical resources courses and events #group 👇👇😎😎✔️✔️🎉🎉💯💯 https://lnkd.in/eUXFKGY2 #FDA #DATA #pharmaceuticals #pharmaceuticalindustry Let's navigate the complexities together! 🚀💡 #Regulatory #Compliance #PharmaTech

Data integrity In the intricate world of pharmaceutical development and manufacturing, data integrity stands as the cornerstone upon which the safety and efficacy of life-saving medications depend. Every test result, every batch record, and every clinical trial outcome contributes to amount of information that guides the production and distribution of medicines. However, regulatory agency inspections are highlighting an increase in findings of data integrity lapses. Agencies, such as the FDA, MHRA and WHO, have published various data integrity guidelines in response to this that emphasize data be reliable and accurate with appropriate risk based strategies in place to prevent and detect data integrity issues.   The above points are covered in a recent post titled “Pharmaceutical Data Integrity”. Any comments? Connect or follow for more knowledge-sharing and empowerment! #gmp #qualityassurance #dataintegrity