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

Courses

https://elearning.expertsinstitut.de/profile/d_gross/

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.…
Qualitätssicherungsvereinbarungen
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Insights into our project experience: Successful implementation of quality assurance agreements (QAA) in the pharmaceutical industry

As part of a project for a pharmaceutical manufacturer and its contract manufacturer, we demonstrated our expertise in the implementation of quality assurance agreements (QAA). The aim of the project was to optimize the quality assurance processes…
ISO 9001

Test

Cannabis

GMP standards for medicinal cannabis: guaranteeing quality in an emerging industry

The medical use of cannabis is gaining increasing recognition and legal approval worldwide, leading to growing demand and increased regulation. In this dynamic environment, Good Manufacturing Practice (GMP) standards are crucial for the production…
Personalberatung

Top talent out of reach? Discover 7 situations in which a recruitment consultancy is your ace up your sleeve!

In today's world of work, talent is often hard to find, especially when it comes to specialized positions or discreet new appointments. But when is it really worth hiring a recruitment consultancy? Here are some key situations where using experts…
Audits
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GxP audits: How important are they and how are they conducted?

In the highly regulated pharmaceutical industry, audits are more than just a control mechanism - they are an indispensable tool for ensuring the quality and compliance of processes. Audits play a key role in ensuring that companies adhere to…
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GMP Guidance for Artificial Intelligence (AI), Machine Learning (ML) and Digital Transformation: How it Finally Begins to Enter the EU GMP Guide

When sifting through today's status of the EU GMP Guide, it does not take an expert to see that there are gaping holes on topics of engineering, management of computerized systems, data integrity, digitalization and application of artificial intelligence.
Informationssicherheit

Information security – a must for modern companies

In today's digital world, information security is more than just a technical concern: it is a business-critical necessity. Companies must protect sensitive data and at the same time meet legal requirements. This article highlights the most…
ISO 9001

ISO 9001 certification: Step by step to a successful QMS

ISO 9001 certification is an internationally recognized standard in quality management. It stands for trust, efficiency and reliability - qualities that customers and business partners value. However, the certification process can seem challenging.…

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