Christian Reinfelder CEO Experts Institut

MBA Business Consulting

Jessica Siefert

CEO

VITA

Experience:

10 years of experience in management consulting

Expertise:

Deviation / change control and CAPA management
Optimization of the QM system
Supplier management
Internal and external audits
Data integrity
Risk management
Regulations / Guidelines
Reporting / Evaluations / SOP
Training for e.g. data integrity, HACCP, GxP

Passion:

Digitalization and sustainability

GMP

Supplier management in the GMP industry: regulatory framework and qualification

Effective supplier management in the GMP sector is more than just an operational purchasing process. In highly regulated environments such as pharmaceuticals, biotechnology or active ingredient manufacturing, the systematic qualification and…

AI, GMP, GXP

Pharmaceutical-grade use of generative AI: regulations, limits and concrete implementation approaches

Generative artificial intelligence (AI) and large language models (LLMs) have long since become part of everyday working life - including in the pharmaceutical industry. However, especially in regulated environments, the question is not whether,…

Sustainability

CSRD in the omnibus procedure: Basics, terms and what companies should know now

The Corporate Sustainability Reporting Directive (CSRD) has significantly increased the demands placed on sustainability reporting by companies. Many organizations are currently faced with the question: What does CSRD actually mean - and what…

KI in der Pharmaindustrie: Annex 22 & EU AI Act

AI, GMP, GXP

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, News

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

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 Solutions

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…

GMP, GXP, Sustainability

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.…

GMP, GXP

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…

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