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Mahtab Shardi

Medical Device Regulation in 2026: FDA, EU MDR and UK Compliance

Medical device regulation is evolving in 2026. Discover how FDA QMSR, EU MDR requirements, and UK rules shape device classification, market access, inspections, and post-market surveillance, with practical guidance for manufacturers seeking stronger quality systems and compliance.
  • Blog, Quality Assurance, Regulatory
FDA accelerated approval connects clinical evidence, regulatory review, and GMP manufacturing readiness to support safe and effective drug development.
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Mahtab Shardi

FDA Accelerated Approval Pathway in 2026: Requirements and Inspection Readiness

How does FDA accelerated approval affect drug development and GMP compliance? Explore clinical evidence requirements, confirmatory trials, postmarketing obligations, and inspection readiness. Learn how pharmaceutical manufacturers can reduce regulatory risks and prepare for FDA approval decisions in 2026.
  • Blog, Quality Assurance, Regulatory
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Deviation vs Nonconformance 2026: 5 Critical GMP Mistakes to Avoid

Explore 5 critical differences between deviation and nonconformance in pharma, including GMP investigations, OOS, risk assessment, and CAPA.
  • Compliance, Quality Assurance, Regulatory
Pharmaceutical quality professionals investigate manufacturing deviations using root cause analysis to identify underlying causes, strengthen CAPA effectiveness, and maintain GMP compliance.
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Root Cause Analysis in Pharmaceutical Industry: 6 Powerful Methods in 2026

Explore 6 powerful root cause analysis methods in pharma to investigate deviations, strengthen CAPA, ensure GMP compliance, and protect patient safety.
  • Compliance, Quality Assurance, Regulatory
Three pharmaceutical professionals in cleanroom attire review a batch record together in a GMP manufacturing facility.
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

Quality Culture in Pharma Industry 2026: Proven Ways to Build Trust

Explore how to build a strong quality culture in the pharmaceutical industry in 2026 through leadership commitment, ICH Q10 principles, meaningful GMP metrics, effective CAPA, and continuous improvement.
  • Compliance, Quality Assurance, Regulatory
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

GMP Training Effectiveness 2026: Proven Ways to Build Real Competence

GMP training effectiveness goes beyond attendance records and quiz scores. Learn how role-based assessments, on-the-job observation, and meaningful KPIs help verify employee competence, strengthen training records, and address recurring performance gaps across pharmaceutical operations.
  • Audit, Blog, FDA, Quality Assurance, Regulatory
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

GMP Audit Checklist 2026: The Essential Guide for Risk-Based Audits

Master your GMP Audit Checklist with a practical, risk-based approach to pharmaceutical self-inspections. Explore five essential audit steps, FDA’s six-system model, GMP documentation and evidence sampling, audit findings, CAPA tracking, and effectiveness verification to strengthen compliance and inspection readiness.
  • Audit, Blog, FDA, Quality Assurance, Regulatory
FDA and EMA regulatory review illustration showing medical plausibility assessments, scientific checklists, a medicine vial, and rare disease patients
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Mahtab Shardi

Orphan Drug Designation in 2026: FDA and EMA Eligibility Criteria

Discover how orphan drug designation works in 2026. Compare FDA and EMA eligibility criteria, rare disease prevalence thresholds, scientific evidence requirements, and regulatory incentives. Learn what pharmaceutical sponsors need to prepare for successful regulatory submissions
  • Blog, Quality Assurance, Regulatory
Quality assurance specialist reviewing a Certificate of Suitability with digital verification icons in a pharmaceutical manufacturing facility
Picture of Mahtab Shardi

Mahtab Shardi

CEP certificate in pharma: What QA Must Verify in 2026

Learn how QA teams verify EDQM certificates, assess API suppliers, and prepare for GMP inspections. This guide explains CEP 2.0 updates, impurity controls, and essential records that help maintain regulatory compliance and inspection readiness across pharmaceutical manufacturing operations.
  • Blog, Quality Assurance, Regulatory
CAPA and Deviation Review in Pharma
Picture of Ershad Moradi

Ershad Moradi

Content Marketing Specialist

GMP Inspection Readiness : A Proven Audit Guide in 2026

GMP inspection readiness means showing that your pharmaceutical quality systems work every day. This practical guide walks QA, QC and site leaders through a five-step, risk-based preparation framework, with priority evidence to review, mock inspection tips, CAPA guidance and answers to common inspection questions.
  • Blog, FDA, Quality Assurance, Quality Control, Regulatory