We’re proud to now offer cGMP Certification Audits and we’d love to bring this coveted distinction to your organization! Our streamlined audit process ensures minimal disruption to your operations while delivering thorough assessments that meet regulatory standards. Learn more below and on our website at https://lnkd.in/gm5TSY2F #cGMP #cGMPCertificationAudit #QualitySystems #ISO17020
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What do we mean when we say that CSQ is an 'Accredited Standard?' It means that our Certification Body, auditors, and technical review process meet certain requirements that aren't at all necessary for a run-of-the-mill cGMP audit. cGMP audits are unaccredited; any auditor can perform an audit without oversight from a Certification Body. If you are still trying to decide what's best for your facility- take a look at this graphic which pinpoints all the major differences. #cgmp #accredited #cannabisproducts
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Gain expertise in the updated AAMI TIR48:2024 for Combination Products through AAMI Training! Key Updates: AAMI TIR48:2024 – QMS Recommendations for Combo Products 📅 May 9 | 1:00 pm - 4:00 pm ET | Virtual AAMI TIR48:2024 reflects changes in regulations and guidance for applying the US FDA cGMP Final Rule on #CombinationProducts. This training provides insights and best practices for understanding and applying Combination Products cGMP expectations, aiding informed decision-making. Topics include key terminology, examples, and considerations for a "Streamlined Approach" and Inspection Readiness. Presenter: Susan Neadle, Principal Consultant & President, Combination Products Consulting Services LLC Learn more here: https://lnkd.in/e6_drPgP #AAMITraining #Compliance #RegulatoryCompliance #MedicalDevices
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Quality Audits, Inspections & Compliance, Quality Assurance Manager, Corporate Quality Assurance, QMS, External Manufacturing Quality, Vendor Audit Management
#Webinar organized by #FDA administration on "Understanding FDA Inspections and Data" in which important topics were explained in detail i.e. FDA inspection model, contributory risk factors for the selection of site inspection, reporting of inspectional finding, site response review and Data Integrity governance. 1.) Applicable Manufacturing Standards. 2.) Understanding CGMP Inspections and 483s. 3.) How FDA Reviews Inspectional Findings. 4.) FDA Regulatory Actions. 5.) Where to find inspection and other compliance documents. #cder #fda #compliance #businesscontinuity #essentialdrugs
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Gain expertise in the updated AAMI TIR48:2023 for Combination Products through AAMI Training! Key Updates: AAMI TIR48:2023 – QMS Recommendations for Combo Products 📅 March 27 | 1:00 pm - 4:00 pm ET | Virtual AAMI TIR48:2023 reflects changes in regulations and guidance for applying the US FDA cGMP Final Rule on #CombinationProducts. This training provides insights and best practices for understanding and applying Combination Products cGMP expectations, aiding informed decision-making. Topics include key terminology, examples, and considerations for a "Streamlined Approach" and Inspection Readiness. Presenter: Susan Neadle, Principal Consultant & President, Combination Products Consulting Services LLC Learn more here: https://lnkd.in/gZS5Yh4G #AAMITraining #Compliance #RegulatoryCompliance #MedicalDevices
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Pharmacist and Consultant in Pharmaceutical Industry #RizophoraWise #Talks about #Iran FDA Regulation, #Iran Health Industry, #Iran Pharmaceutical Industry Data
According to USFDA regulation; cGMP stats for current GMP guidelines those are updated periodically by the regulatory agencies for GMP inspection. cGMP is focused on incorporating the latest standards and technologies for continuous improvement. #RizophoraWise #cGMPVsGMP #PharmaceuitclaRegulation
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We live and breathe regulatory compliance. Azzur Group's GMP consultants are immersed in the standards set forth by the FDA, EMA, and other regulatory bodies including: ✅ 21 CFR Parts 11 and 820 ✅ FDA 2011 Process Validation Guideline ✅ Eudralex Volume 4 (EU cGMP Guideline) Have questions about your quality and compliance? Get your answers here: https://azzur.co/3xbIL8H #Compliance #GxPConsulting #LifeScience
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It was a knowledgeable webinar about "Understanding FDA Inspections and Data" was held on September 6, 2023. This webinar includes: • Applicable Manufacturing Standards • Understanding CGMP Inspections and 483s • How FDA Reviews Inspectional Findings • FDA Regulatory Actions • Where to find inspection and other compliance documents #learningandgrowing #fdacompliance #inspections #webinar
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🌐 Critical Gaps Revealed: FDA exposes significant CGMP standard breaches in Pharma Industry. Procedural lapses and integrity issues pose contamination risks. 🌟 Linking Excellence & Compliance: CGMP adherence crucial for risk reduction. Explore the nexus in this post. 🚀 Boost Compliance with eQMS: Harness the power of eQMS for solid compliance. Enhance efficiency, reduce deviations, and uphold regulatory standards with cutting-edge tech. How do you manage it? Share your compliance strategies below. 💬🔒 #QualityMatters #fda #GMP #risk #BizzMine
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Assisted line clearance enhances product quality and safety by minimizing the risk of cross-contamination and contamination-related issues. By thoroughly cleaning equipment and clearing the line thereby eliminating any traces of previous products, manufacturers can maintain strict adherence to regulatory requirements and industry standards, ensuring that their products meet the highest quality and safety standards while reducing the risk of human error. Nolan Horan shares his insights into this important cGMP topic. https://lnkd.in/gcxtjFnr #cGMP #LineClearance #IndustryExpertise #Quality #ProductSafety
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💎 Customized in-house courses for Pharma and Biotech 💎 Partnering with Top Industry Experts 💎Trusted by 150+ companies
Looking to enhance your expertise in GMP compliance? Check out this valuable course from Symmetric Training! Ideal for professionals working on the development of the GMP Lead Audit, this course provides a comprehensive understanding of GMP principles, regulatory requirements, audit plans, checklists, and reports, classification of audit findings, and practical auditing skills. By taking this course, you can empower yourself to contribute effectively to maintaining and improving the quality of products in regulated industries. Don't miss out on this opportunity to enhance your skills and knowledge! #GMP #EMA #FDA #compliance #onlinecourses #Pharma #SymmetricTraining
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