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KI in der Pharmaindustrie: Annex 22 & EU AI Act
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AI in the pharmaceutical industry: Annex 22 & EU AI Act – current obligations and practical implementation

The use of artificial intelligence (AI) is rapidly gaining importance in the pharmaceutical industry - from increasing efficiency in everyday office work to complex applications in GMP-relevant processes. At the same time, regulatory requirements…
GMP
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The most important GMP findings for 2025 and forecasts for 2026

The regulatory requirements in the GMP environment have changed noticeably in recent years. In 2025, it is clearer than ever that it is no longer enough to formally fulfill requirements. Authorities expect comprehensible decisions, stable processes…
GMP-Audits

Mastering GMP audits successfully: What really matters

GMP audits are one of the key quality assurance tools in the pharmaceutical and life science industry. They check whether manufacturing processes, documentation, systems and working methods comply with regulatory requirements at all times.…
Business Continuity

Business continuity management: How companies strategically secure their resilience

In a world where disruption has long since become the norm, business continuity management (BCM) is no longer an option, but a necessity. Whether cyber attacks, natural disasters, supply chain disruptions or IT failures: Crises affect companies…
Continuous Manufacturing
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Continuous manufacturing: future trend in the pharmaceutical industry

The pharmaceutical industry is at a turning point. For decades, traditional batch processes characterized the production of pharmaceuticals. Although these have proven their worth, today they are often considered rigid, slow and resource-intensive.…
Qualitätsmanagement
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How to create an effective quality management system (QMS) in accordance with ISO 9001

A quality management system (QMS) in accordance with ISO 9001 is much more than a formal set of rules - it is a strategic tool that companies can use to make their internal processes transparent, reliably meet customer expectations and build…
Informationssicherheit

ISMS 2024: What companies need to know now about NIS2, DORA, CRA and ISO/IEC 42001

The demands on information security are increasing rapidly and with them the regulatory pressure. Cyber attacks such as ransomware, supply chain attacks and targeted attacks on critical infrastructures have long been part of everyday life.…
Deviation Management

Enhancing Process Stability through Effective Deviation Management

Focus topics: Deviation Management, Process Stability, CAPA, Regulatory Compliance, Operational Excellence In today's fast-paced, highly regulated industries, maintaining process stability and ensuring product quality are paramount. Deviation…
Supplier-Audit Reports
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Untrue Supplier-Audit Reports: The Danger of Ethnocentric GMP-Auditing

If You are in any QA / QU role and are responsible for audits and audit reports in the GxP-context, I encourage You to take time and read this, it will be worth Your while. And if You are a QP (like I have been), this is likely to help You.…
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