Dr. Michael von Gönner

 Senior Quality Consultant – Life Science

+49 152 26144919

GMP Advice

GMP Advice is an independent service company that specializes in consulting and implementing GMP and EHS requirements in the life sciences industry

 

GMP Advice supports pharmaceutical and biotech companies in all questions regarding compliance with legal standards and regulations, in particular good manufacturing practices (GMP), but also  environment, health and occupational safety (EHS)


GMP Advice understands complex situations and tasks, develops well-founded and pragmatic solutions, supports customers in implementation and gets involved

… with expertise, empathy and enthusiasm.

Interim Management


For a temporary project or as a temporary manager, I would be happy to support you in the confident and successful implementation of demanding projects in quality management or in a direct line function.



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Introduction, review and support of quality systems

The efficiency and functionality of the quality systems is a fundamental prerequisite for GMP compliance. There should be tailor-made solutions that are adapted to the size and structure of the company.



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Occupational safety issues

GMP-Advice offers quick and efficient solutions for various topics:
Risk assessments, integrated management systems, EHS audits, training for employees, introduction of online training in occupational safety, handling of cancerogenic substances and much more.

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Dr. Michael von Gönner

Senior Quality Consultant – Life Science

Doctorate in biology, with over 20 years of broad management experience in the pharmaceutical industry in the areas of QA, QC and production of biotechnologically produced active ingredients, including contract manufacturing
 

Consulting Service GMP


The focus of the service is on consulting and implementing projects on GMP compliance. The range of services extends from the initial analysis to the development of concepts and their implementation through to on-site execution.

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Consulting Service EHS


(Environment, Health & Safety)

In all companies, the issue of maintaining legal compliance with regard to the environment, health and occupational safety is the focus of efforts to serve corporate governance.

The first step in a consulting service is therefore usually a compliance audit or check. I look at the current situation in the company and, together with the customer, develop suggestions for effective and tailor-made solutions. However, individual topics can also be in the foreground that are the focus of a consultation.


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 21


National/international authority inspections

200


Internal audits

100


Supplier audits (raw materials and primary materials)

24


Years management experience
 Never give up on what's important to you, just because it's not easy.

(Albert Einstein)