Operational Consultancy & Interim Management

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Day: 27 September 2020

Bio/Pharma Maintenance 4.0: How To Get Started.

27 September 2020 Tobias 0

Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, […]

Maintenance 4.0 – The Next Revolution In Bio/Pharma Manufacturing

27 September 2020 Tobias 0

Pharma 4.0 is an all-inclusive term for a broad range of technologies and approaches, including devices and connected sensors that make up Big Data, the […]

An Introduction To Centerlining For Biopharmaceutical Manufacturing

27 September 2020 Tobias 0

For many years, preventative maintenance has been part of routine work processes at most bio/pharmaceutical companies. The challenge in most cases is striking the right […]

GDP Extended – Also covering API

27 September 2020 Tobias 0

Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and […]

How to read Regulatory Syntaxes

27 September 2020 Tobias 0

In this short note an explanation is provided how to read regulatory syntaxes. In your native language that may not be to difficult but when […]

More interesting stuff

  • Asset Life Cycle & Validation
  • Assignments & Project
    • FDA Part 11 – Eudralex V4 Annex 11 – ISPE GAMP 5
  • Executive Coaching
  • Interesting links & suggestions
    • Familiarizing with cGMP
    • Lean Maintenance
    • Plan of Control
  • ISO-13485 vs 21 CFR Part 820
  • Kosten voor Medicatie – Gedifferentieerd en met blik op de toekomst
  • Privacy Policy
  • Recommended Links and Business Library
  • The 5-Step Checklist For A More Mature, Robust Quality Management System

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