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𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐲: 𝐄𝐔 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧 𝐑𝐨𝐚𝐝𝐦𝐚𝐩 🇪🇺 In this blog, Nicole Piscopo, Quality Assurance, Pharmacovigilance Specialist, and GxP Auditor at Quintian Pharma shares a case study outlining the timelines and steps manufacturing companies must take to obtain EU certification for their products. A must-read for any company looking to register its products in Europe but unsure where to start! 📄 Wait no longer: https://lnkd.in/dRPqyM4y #EUCertification #ProductRegistration #QualityAssurance #Pharmacovigilance #GxPCompliance #RegulatoryAffairs #PQEGroup #Quintianpharma #CaseStudy #EuropeanMarket

Hello connections I am very proud for sharing another achievement with you I have completed 1 month certification course in drug regulatory affairs (DRA) in clini India ,With A grade This course have definitely helped me in understanding a key concepts and skills regarding pharmaceutical drug regulatory affairs. A key skill that I was able to learn from a drug regulatory affairs course is the ability to navigate complex regulatory frameworks and ensure compliance with local and international laws. This includes understanding the drug approval process, preparing regulatory submissions, and communicating effectively with regulatory agencies. Additionally, I have also develop skills in risk assessment, data analysis, and project management within the pharmaceutical industry The skills and knowledge I have able to acquire from this course are as follows ○Regulatory Compliance ○Investigational New Drug (IND) ○New Drug Application (NDA) ○Abbreviated New Drug Application (ANDA) ○Drug master file (DMF) ○Common technical documents (CTD) ○Orange book ○Good Manufacturing Practices (GMP) ○Good Clinical Practices (GCP) ○Pharmacovigilance ○Adverse Drug Reaction (ADR) ○Clinical Trials ○Drug Approval Process ○Biologics License Application (BLA) ○Post-Market Surveillance ○Labeling Requirements ○Risk Management ○Regulatory Dossier ○Market Authorization ○Quality Assurance ○International Conference on Harmonisation (ICH) ○Therapeutic Equivalence ○Reimbursement #regulatoryaffairs #pharmaceuticalindustry #pharmaceuticals #regulatorystrategy #regulatoryintelligence #regulatorylaw #fda #fdaapproval #jobsalerts #pharmaceuticalindustry #pharmajobs #regulatoryaffairs #RegulatoryAffairs #Pharmalnsights #CareerGrowth #PharmaceuticalIndustry #regulatoryaffairs #drugsafetyassociat #regulatoryaffairs #biostatistician #trending #support #professionaldevelopment #skilldevelopment #education #learning #management

March 2024 is when the FDA FULLY adopted ICHQ14. The question is, "can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?" Extending the ICH Q14 approach to Quality Control method performance offers the benefit of quickly identifying changes in performance. This allows for a proactive root-cause analysis and mitigation plan to address any potential drift in method performance promptly. The ICH Guideline Q14 Analytical Procedure Development introduces the application of QbD tools, such as design of experiments (DoE), to enhance the life cycle management of methods. Design of experiments is a methodical procedure used to establish the relationship between process factors and their impact on process output. #newregs #Mar2024=FDAAdoption # https://lnkd.in/eVpwjHF3 #ISPEguidelines #writetheguidance #ISPEbestpractices #cGMP #bestpractices #regulationschange #staycurrent

📊 Attention Pharma Professionals! 🔬 Navigating the complex world of pharmacovigilance? 🌍 We've got you covered! 💼 Discover our comprehensive, free guide to National LCPPV Requirements. Stay ahead of regulatory changes and ensure compliance across different countries. 🏆Download now and boost your pharmacovigilance knowledge! 📚💡 #Pharmacovigilance #RegulatoryCompliance #LifeSciences #DrugSafety

🧵 Regulatory Affairs ⚡️ANDA Submission: Covers the requirements and process for submitting an Abbreviated New Drug Application (ANDA) to regulatory authorities. ⚡️Regulatory Challenges: Addresses common regulatory challenges faced during generic drug development, such as patent infringement and data exclusivity. ⚡️Post-Approval Changes: Discusses the procedures for making changes to an approved product, including variations and supplements to the ANDA. Post-Marketing Surveillance ⚡️Pharmacovigilance: Covers the importance of monitoring the safety and efficacy of a generic drug product after market approval. ⚡️Risk Management: Discusses strategies for identifying, assessing, and mitigating risks associated with generic drug products. ___ By understanding these key concepts, professionals involved in #genericdrug development can navigate the complex regulatory landscape and ensure the development of safe, effective, and high-quality #genericmedications.

Check out the key differences and similarities between GCP and GMP. GCP (Good Clinical Practice) - Focus: Clinical trials, human subjects - Ensures safety, efficacy, ethics - Regulations: ICH-GCP, FDA 21 CFR Part 312 - Key Principles:   - Informed consent   - Confidentiality   - Adverse event reporting   - Data management and integrity GMP (Good Manufacturing Practice) - Focus: Pharmaceutical manufacturing, product quality - Ensures product quality, safety, purity - Regulations: FDA 21 CFR Part 211, EU GMP Directive - Key Principles:   - Quality control   - Quality assurance   - Batch release Overlapping Areas: - Quality control/assurance - Documentation/record-keeping - Training/personnel qualifications - Audits/inspections Key Differences: - GCP focuses on clinical trials; GMP on manufacturing - GCP emphasizes informed consent, confidentiality; GMP emphasizes quality control Similarities: - Both ensure safety and efficacy - Both require documentation and record-keeping - Both involve audits and inspections Importance of Compliance: - Protects human subjects and patients - Ensures product quality and safety - Maintains regulatory compliance - Upholds industry reputation Stay Compliant! - Understand GCP and GMP differences and similarities - Implement quality control and assurance measures - Conduct regular audits and inspections - Train personnel on regulations and guidelines Do follow Infinitive Bio Research Inc for more updates on Clinical Research #GCP #GMP #ClinicalResearch #PharmaceuticalManufacturing #RegulatoryCompliance #QualityAssurance #ClinicalTrials #Pharma #Biotech #Healthcare

Quality by Design (QbD) is a systematic approach in pharmaceutical development focusing on designing processes to ensure product quality. It involves defining a Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), conducting risk assessments, and establishing a design space where processes yield desired quality. QbD also includes developing a control strategy for consistent quality and continuous improvement throughout the product lifecycle. Benefits include enhanced product understanding, reduced risks, regulatory flexibility, and increased efficiency. Regulatory agencies like the FDA and EMA support QbD, promoting proactive quality management and smoother approval processes. #QualityByDesign #QbD #PharmaceuticalDevelopment #PharmaQuality #DrugDevelopment #QualityControl #ProcessOptimization #RiskManagement #PharmaceuticalEngineering #ContinuousImprovement #RegulatoryCompliance #FDA #EMA #PharmaInnovation #QualityAssurance #LifeSciences #PharmaceuticalScience #ProductQuality #PharmaIndustry #PharmaManufacturing

🎗️Regulatory Release Alert🎗️ FDA released a new guidance to help sponsors create successful drug development programs that address the various challenges posed by rare diseases. The guidance encourages sponsors to engage early with the Agency to discuss their drug development program to ensure the successful development of their drugs! Link to guidance ➡️ https://lnkd.in/eARpU-zg    📚 The final guidance is attached below ↓ 🎗️Let us Collaborate🎗️ WKM Consulting Services LLC provides top-notch Quality and Compliance consulting services that include: ➡️GxP vendor audits ➡️ Internal mock inspections ➡️ Inspection readiness training ➡️ Comprehensive gap assessment, FMEA, and Risk Assessment of your systems, processes, and procedures. Additionally, We offer the following consulting services: ➡️ Quality Control (QC) ➡️ Quality Assurance (QA) ➡️ Vendor Management (VM) ➡️ System Validation (SV) ➡️ Project Management (PM) ➡️ Toxicology 📲Follow our page “WKM Consulting Services LLC” on LinkedIn to be notified when new regulatory updates are released. 📩Get your free consultation: ➡️ E-mail: drwafick@gmail.com ➡️Phone: 510-509-4195 Thank you 🙏 #WKM #WKMConsultingServices #RequestaService #Audits #WKM #Consulting #Services # FDA #Regulations #FDA #inspection #ICH #NIST #Collaboration #expeditedPrograms #AcceleratedApproval #Drugs #Biologics #USFDA #warningletters #CodeofFederalRegulations #CFR #FDA #FDAwarningletters #Regulatorycompliance #Pharmaceuticalregulations #NDA #IND #PLA #BIMO #inspection #electronicsubmission #EMA #GCP #InspectorReport #Rarediseases #guidance

🎉 Excited to share that I have successfully completed the Pharma Drug Regulatory Affairs Certificate Course (DRA 2024) on #Udemy! 🚀 This course has been instrumental in refreshing and deepening my knowledge in Drug Regulatory Affairs (DRA) and preparing me to re-enter the pharmaceutical industry with confidence. During the course, I had the opportunity to enhance my understanding of key areas, including: - DRA (Drug Regulatory Affairs) processes and frameworks - Orange Book and its importance in pharmaceutical approvals - USFDA regulations and guidelines - eCTD and CTD submission processes - INDA, NDA, ANDA, and DMF filing requirements - Global regulatory standards, including ICH guidelines - Hands-on experience with software demos and regulatory tools - I also had the opportunity to test my skills through #quizzes and #practical exercises, enhancing my ability to navigate the complex regulatory landscape of the #pharmaindustry. This course has helped me regain my expertise and build on my previous experience, equipping me with updated knowledge and practical skills needed to excel in the current regulatory environment. I’m excited to leverage these insights and make valuable contributions to the pharma industry again! 💼💊 #Pharma #DrugRegulatoryAffairs #PharmaceuticalIndustry #USFDA #NDA #ANDA #DRA #eCTD #ProfessionalDevelopment #JobSeeker #HireMe #CareerOpportunities #JobHunter #JobSearch #Networking.

|WHO Listed Regulatory Authorities| WLA (24th May 2025) World Health Organization A WHO Listed Authority (WLA) is a regulatory authority (RA) or a regional regulatory system (RRS) that complies with all the relevant indicators and requirements specified by WHO for regulatory capability as defined by an established benchmarking and performance evaluation process. A regulatory authority provides the framework that supports the WHO recommended regulatory functions. This is the authority and affiliated institutions that are responsible for regulatory oversight of medical products in a given country or region and in charge of assuring the quality, safety and efficacy of medical products as well as ensuring the relevance and accuracy of product information. The WLA replaces the Stringent Regulatory Authority (SRA) definition https://lnkd.in/ddW_5zEW #RegulatoryAffairs #QualityControl #QualityAssurance #ResearchAndDevelopment #Pharmaceuticals #Biotechnology #LifeSciences #MedicalDevices #ClinicalResearch #RegulatoryCompliance #GMP #FDARegulations #HealthcareQuality #DrugDevelopment #ComplianceManagement #RegulatoryScience #RnD #BioPharma #ProductDevelopment #RegulatoryUpdates #PharmaRegulation #HealthAuthority #DrugRegulation #PharmaCompliance #RegulatoryAffairs #FDA #EMA #MHRA #TGA #HealthCanada #PMDA #SFDA #NMPA #ANVISA #CDSCO #Drap #nafdac #efda #gfda. #who #pics #sahpra