Dipl. Ing.

Wolfgang Rudloff

CEO

VITA

Experience:

  • 30 years of experience in the pharmaceutical industry

Expertise:

  • Certified expert for cleanroom technology and GMP management
  • Lead auditor and assessor

Stations:

  • Technical Manager
  • COO / Overall Production Manager
  • Remidiation Manager
  • Project manager new building/GMP upgrade
  • Management GMP consulting
  • Specialist author, GMP trainer, mediator
VSME-Standard für KMU
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Combining sustainability and success: The new VSME standard for SMEs

Sustainability is becoming increasingly important in corporate management, particularly in the wake of new regulatory requirements at European level. For large companies that are already covered by the CSR Directive Implementation Act (CSR-RUG),…
Keyword
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Quality Management Maturity: The Importance of Good English Writing Practices (GEWP)

English is common for most who work in a GxP-regulated industry. Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding…
Cultures in Audits & Inspections
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Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company's staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite…
Cultures in Audits & Inspections

Crossing Cultures in Audits and Inspections

Today the world, with its regulated industry, is strongly globalized. The cultural diversity of a company's staff can be huge. This is one reason why many would assume that the entire world can be talked to, related to and understood quite…
Retaxation

Retaxation – a lucrative instrument for health insurance companies

-Blog post on the subject of retaxation Retaxations in pharmacies mean that the health insurance companies reclaim money that they have previously paid to pharmacies for the dispensing of medicines. This usually happens up to 15 months after…
Computergestützte Systeme
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Computerized systems (CS)

CS are becoming increasingly important, especially in the pharmaceutical industry, in order to meet the increasing demands on production. At the same time, their use must not compromise patient safety. This brings with it increasing challenges…
Künstliche Intelligenz

Artificial intelligence (AI) in consulting

How artificial intelligence is revolutionizing management consulting: Insights into a future where consultants and AI, go hand in hand AI until 2030 In the rapidly evolving business world, companies face the challenge of keeping up…
Lieferantenqualifizierung
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Supplier qualification for pharmaceutical manufacturers

Blog post: Field report by an EI consultant from a supplier qualification project for pharmaceutical manufacturers In the period from 2019 to 2022, I was involved in a project for the supplier qualification of drug manufacturers and active…
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GMP AND DIGITALIZATION: SOME BASIC THOUGHTS

It is almost 8.00 am, we are standing on front of a building which houses an officially GMP-accredited contract laboratory service. Our task for today: carry out a full blown GMP-audit on the contract lab. On the inside I am a bit excited,…


Neustadt

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Bamberg

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Freiburg

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St. Gilgen (Austria)

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