We offer a number of training courses on issues of legal requirements (ISO 14644), documentation and standards of work in clean rooms. Each training is individual and is designed to the needs of a particular company and business. Training consists of theoretical and practical parts.
Our offer
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Training / workshops
Our training run on the basis of an individual program designed to your needs and the specificities of the company. They are led by experienced experts, practitioners with expertise and many years of professional experience. We want the knowledge we share to be used in your everyday work. We organize open training in Katowice, Lodz and Warsaw, as well as closed workshops and trainings, in your company building./ in your company office.
We encourage you to check our current offer of trainings/ workshops …
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Audits
The advisory offer is based on a constant work between you and us. We will indicate what to look for when working in clean rooms, how they should be designed and equipped. We will also point out CLEAN ROOM standards that should be met so they comply with the requirements of ISO 14644 / GMP. We have many years of experience working for the label pharmaceutical companies, tissue and cells banks, health care units and pharmaceutical wholesalers.
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Advisory
The advisory offer is based on a constant work between you and us. We will indicate what to look for when working in clean rooms, how they should be designed and equipped. We will also point out CLEAN ROOM standards that should be met so they comply with the requirements of ISO 14644 / GMP. We have many years of experience working for the label pharmaceutical companies, tissue and cells banks, health care units and pharmaceutical wholesalers.
We encourage you to check our advisory programme…
Read more"The good thing is to help others,
but still it is better to teach them
how to help themselves."
George Orwell
TRAINING AND ADVISORY OFFER
GMP
Good Manufacturing Practice, which is all you need to know about procedures at every stage of pharmaceutical production
GDP
Good Distribution Practice, that is all you need to know about the requirements and principles of distribution of medicinal products
ATMP
ATMP is a new category of medicinal products produced on the basis of gene therapy, somatic cell therapy or tissue engineering. A few years ago these products were made in the ordinary, traditional labs, but because of the changes in law, according to GMP production of ATMP has to take place in clean room.
GLP
In our offer you will find training on legal requirements and documentation and labor standards in GLP laboratories DLP is a system of high quality and reliability of performed tests and of collecting results from the moment of planning until the proper storage of data sources and reports, so that we can trace the course of the investigation or its complete restoration.
PN-EN ISO 14644
As early as designing a room attention is paid to minimize the presence, accumulation and settling of particles which may affect the production process. Infrastructure which needs to meet such a requirements includes buildings, air conditioning systems, media and the connection between all of them. The ISO 14644 defines the requirements of the design and construction of clean rooms, and a list of important parameters for their functioning.
OFFER AUDITS
Advanced therapy medicinal products
According to the requirements:
- The Act of 1 July 2005. On the collection, storage and transplantation of cells, tissues and organs
- Pharmaceutical Law of 6 September 2001.
- Regulation of the Minister of Health of 1 October 2008 the requirements of Good Manufacturing Practice – for medicinal products
- Regulation of the Minister of Health on 9 October 2008. On the requirements to be met by a quality assurance system in the banks of tissues and cells
Medical products
According to the requirements:
- Pharmaceutical Law of 6 September 2001.
- Regulation of the Minister of Health of 1 October 2008 the requirements of Good Manufacturing Practice
- Direct packaging materials for medical products – BS EN ISO 15378: 2012
Pharmaceutical warehouse
According to the requirements:
- Regulation of the Minister of Health of 12 March 2015 on the requirements of Good Distribution Practice
- Regulation of the Minister of Health of 12 March 2008. On the detailed rules and procedures for withholding and withdrawal of medicall products and medical devices,
- Directive of the European Parliament and of the Council 2011/62 / EU on preventing the entry of falsified medicinal products into the legal supply chain.