Alexander Diamandidis

Pass Your First GMP Audit in QC Nail the basics. Show control. Prove data integrity. 🚀 Your 7-step playbook Prep: Current SOPs, training matrix, clear RACI. Records: ALCOA+ docs, real-time entries, version control. Methods & Equipment: Validations, IQ/OQ/PQ, calibration logs, standards traceability. Data Integrity: Audit trails, access control, backups, e-signatures, change control. Training & CAPA: Role-based refreshers, tight CAPA timelines. Mock Audit: Risk-based self-inspection, doc room, SME brief, evidence index. Audit Day: One voice, fast retrieval, clean narratives, calm execution. CTA — Get audit-ready now 📚 Build your GMP skills HERE: https://lnkd.in/dK5xJRd2

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Understanding ICH Quality Guidelines: A Quick Overview 🌍⚙️ The International Council for Harmonisation (ICH) Quality Guidelines are essential for ensuring the safety, efficacy, and quality of pharmaceuticals worldwide. Here's a quick summary to keep you informed: Watch NOW PHARMATALKS FULL Podcast HERE👉💯🔗😎 https://lnkd.in/dpCnEC7k Understanding ICH Quality Guidelines: A Quick Overview 🌍⚙️ The International Council for Harmonisation (ICH) Quality Guidelines are essential for ensuring the safety, efficacy, and quality of pharmaceuticals worldwide. Here's a quick summary to keep you informed: 1. Q1 Series (Stability Testing) 🧪 Focuses on stability testing protocols to determine shelf life and storage conditions. 2. Q2(R1) (Analytical Validation) 🔬 Provides guidance on validating analytical procedures to ensure accuracy and reliability. 3. Q3A/B (Impurities) 💊 Addresses impurities in drug substances and products, emphasizing control strategies. 4. Q4B (Pharmacopoeial Harmonization) 📚 Facilitates harmonization of monographs across different pharmacopoeias. 5. Q5 Series (Quality of Biotechnological/ Biological Products) 🧬 Covers quality considerations specific to biotech and biological products. 6. Q6A (Specifications for New Drugs) ✅ Sets standards for defining product specifications during development. 7. Q7 (Good Manufacturing Practice - GMP for APIs) 🏭 Guides manufacturing practices for active pharmaceutical ingredients. 8. Q8-Q11 (Pharmaceutical Development & Lifecycle Management) 🔄 Encompasses principles of quality by design, lifecycle management, and continuous improvement.

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GenAI is changing Regulatory Affairs – but are you up to speed?   In this on-demand session, hear from Regulatory teams who are actively leveraging GenAI and advanced automation to streamline operations, increase precision, and stay compliant in an ever-changing environment.   You’ll see firsthand how you too can drive up to 50% efficiency gains and save your team hundreds of hours by streamlining Regulatory workflows with automation.   Featuring speakers: Hans van Leeuwen Global Head Regulatory Operations, Astellas Steve Gens MSOD, Managing Partner, Gens & Associates Michael Sonntag, Director Regulatory Affairs & PV, Wörwag Pharma   Watch on-demand now: https://lnkd.in/e4Vmr8BV #RegulatoryAffairs #Pharma #PV #AI #GenAI #Automation #RegulatoryWorkflow

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EMA eCTD v4 – Validation Rules published As the next step in the EMA eCTD v4 transition, the EMA has published the regional validation rules on 01 August 2025. The rules are broken down into two key criteria: 1. ICH Rules 2. EU regional rules which consist of 11 defined rules. Learn more in our blog post: https://lnkd.in/deygmhhs Adhering to an authority’s validation rules is essential to the success of your submission. As part of EXTEDOpulse, EXTEDO’s Submission Management Hub ensures the highest possible accuracy when validating submissions and guarantees up-to-date validation sets at all times. More than 35 regulatory authorities worldwide rely on EXTEDO’s technologies to validate incoming submissions. By using EXTEDOpulse, your organization will benefit from identifying compliance risks quickly, resulting in a more efficient submission process and faster time-to-market. Being a trusted partner of the EMA and an expert in validation and all other submission processes, EXTEDO welcomes the publication of the validation guidelines. This is another important milestone for the EMA on its journey to eCTD 4.0. We are ready to accompany the EMA and other authorities, as well as the pharmaceutical industry, on this journey! #EXTEDO #EMA #Validation #eCTDv4

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Are Process Deviations Slowing You Down? Process deviations can derail production, trigger regulatory findings, and lead to costly delays. But with the right strategies, you can detect, classify, and prevent them like a pro. 👇 Here’s your quick checklist for GMP success: ✅ Understand the difference: deviation vs. variation ✅ Classify issues as minor, major, or critical ✅ Use tools for real-time detection and analysis ✅ Investigate thoroughly and apply strong CAPA ✅ Train staff and update SOPs regularly ✅ Involve Regulatory Affairs in deviation documentation ✅ Review deviation trends to prevent recurrence 📊 Stay audit-ready and quality-focused by mastering the full deviation workflow. 🎓 Want to upskill in deviation handling and compliance? 👉 Start here: Pharmuni’s Introduction to Regulatory Affairs https://lnkd.in/gQVnY8H4

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Pharmaceutical companies in the US are requesting additional information on how to conduct stability testing for both new and existing drugs in response to the ICH recent Q1 guideline. They have raised questions regarding the scope of the guideline and the appropriate timing for stability testing of drugs in development. These comments were in response to FDA's call for responses on the Q1 guideline. Joanne Eglovitch reports for Reguatory Focus: https://hubs.la/Q03F_SV00

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📜 What Certifications Impress Recruiters Fast Want to stand out in the pharma job market? These certifications boost your profile: • 🧪 GMP Certification – Demonstrates compliance and quality knowledge. • ⚙️ CQE Certification – Proves your quality assurance expertise. • 📈 Six Sigma Certification – Highlights your process improvement skills. • ✔️ CQPA Certification – Validates your ability to analyze quality processes. 🚀 Explore certification on Pharmuni https://lnkd.in/dPBe5T-z 

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The FDA has finalized its new Quality Management System Regulation (QMSR) — fully harmonized with ISO 13485:2016 — with an effective date of February 2, 2026. ✅ One Quality System for FDA + international markets ✅ Streamlined global market access ✅ FDA inspections aligned with ISO 13485 While 2026 may feel distant, the time to act is now. Transitioning early ensures your organization is inspection-ready and positioned for global compliance success. At Nemko, we’re here to support with ISO 13485 certification audits, gap assessments, supplier audits, and integrated certification services. 🔗 Read the full blog to learn what this shift means for your business: https://lnkd.in/evAmF4Qf #MedicalDevices #FDA #ISO13485 #QMSR #GlobalMarketAccess #RegulatoryCompliance #Nemko

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