Dr. rer. nat.
Dietmar Gross
COO
VITA
Experience:
- COO Experts Institute
- Senior Project Consultant
- Pharmacist
- Many years of international project work in Europe, North America, Asia, Russia
- Competent person (D AMG, AMWHV, CH HMG, AMBV)
- Broad compliance expertise in commercial (c)GMP and development GMP (IMP GMP)
- Long-standing third party GMP auditor (GMP and non-GMP)
- GMP/GDP trainer since 2010
- Quality Culture Mediator
- Trained in cross-cultural aspects of communication, contextualization, and cultural anthropology as part of an MA.MIn and DIcs enrollment at Grace College&TS, US
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),…
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…
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…
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 – 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…
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…
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…
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…
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,…