Build GMP into your facility from the start with an owner consultant

In this article you can read about how an independent owner consultant can create value. Especially through assessment of the enterprise and through continuous monitoring of the progress. This is interesting if you are responsible for expanding a production, for new GMP facilities, or have an enterprise task to be solved. Especially if you do not have an established project organisation or project execution model.

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The consultancy A-consult lives on in a professionally strengthened AlfaNordic

After 35 years as an independent consultancy, A-consult opens a new chapter at the start of 2020, together with AlfaNordic: Since June 2018, when AlfaNordic bought A-consult, the two consultancy have gradually worked closer together by sharing knowledge, consultants and experience. From 1st January, 2020, they will also share their names as the collaboration continues under AlfaNordic A/S.

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Learnings from an Organisational project

Changing infrastructure in busy organizations can be a complex task. Understanding the limitations, opportunities and finding a solution best suited for all the involved departments and colleagues is challenging. Especially for business critical processes, the ability to make the right decisions is crucial for the future of the business. This article will highlight some of the challenges our consultants experiences and is a window into our processes and results.

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How can the life science industry meet the authority requirements for risk analysis and management?

We have more than 10 years' experience with GMP services for the life science industry, including how to interpret authority requirements in relation to the implementation of Quality Risk Management (ICH Q9) and quality risk management as part of the company's risk assessment . We want to be the leading consultants and have performed many risk analysis projects since ICH published Q9 in 2006.

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New validation package which ensures cost-effective validation of temperature-controlled facilities

Validering af temperaturstyrede faciliteter og udstyr kan opleves som en tids- og kompetencekrævende opgave. Dog er det nødvendigt ift. gældende krav – hvilket gør at der må tænkes i andre baner ved at holde fast i den høje kvalitet, der sikrer at produktet er produceret og opbevaret i rette omgivelser samt
virksomheden er i compliance i forhold til gældende guidelines.

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How do you make your project a success?

For more than 10 years AlfaNordic has worked with projects within the life science industry, and through this work a number of issues, which often result in delays or exceeded budgets, have been identified. For this reason we have developed Project Due Diligence. Project Due Diligence is a consultancy service with focus on ensuring the availability of the basic prerequisites for a successful project execution, incl. that the right allocation of resources and management focus etc.

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Paths are made by walking

When Saad Nisar finished as a pharmacist in August 2016, he came to a labor market that was in turmoil due to mass layoff in the industry, a new pharmacy law and cuts and restructuring in individual pharmacies, but Saad was, after all, immediately offered a job at a pharmacy where he had been a student assistant. He immediately informed the pharmacist that his ambitions were in the pharmaceutical industry and that he intended to look for positions there, but still got the job.

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Mr. Education will be 60 years

In 2011, at the age of 53, Christian Ilsøe is offered to buy into AlfaNordic. He has never been self-employed before. Christian has over 25 years of experience in the pharmaceutical industry, in professional positions and management positions. Among other things, he has been in the Novo Nordisk Group for 21 years and also served as CEO of DS Certification

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And then I'll ask you what your beach looks like

Rasmus Kriegel has a background as a pharmacist. He got his degree in 2002 and after he completed his education, he worked at Rådhusapoteket in Lyngby. Here he developed a broad knowledge of pharmaceutical products and got acquainted with sales; The “good sale” which is about entering into a dialogue with the customers to identify their actual needs and give them exactly what they need. Already here, Rasmus developed a good understanding of how to meet a need despite the fact that customers are not always aware of exactly what solution will solve their challenges.

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AlfaNordic welcomes a new team of young talents to the life science industry

We are pleased to welcome our 10 new Pharma Academy Graduates. The team has now been through a challenging boot camp, an intensive on-boarding program, and the graduates have now started working on their first tasks. This year’s Pharma Academy Graduates are: Asger Risager Nørgaard M.Sc. in Medicinal Chemistry, Aarhus University Katrine Bolvig Hansen M.Sc. […]

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Stuff that works - with inspiration from the wolves

Preben Werther has just turned 66 years. It is not possible to look at him, but there is thus some water in the river, as he says. He communicates visually. It makes a lot more sense to him. He speaks a pictorial, colorful language so it's understandable. He has a heavy military background as an officer for over 25 years with all the additional training and training that comes with it. There have been under 400 hunter soldiers since 1961. Preben is number 197. He himself has been through it all, and has subsequently been responsible for educating many. Over a period of 12 years he has been called the Commanding Officer Training Wing.

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Ultimate will

If you want to put a sticker on Henrik Bjørn Linnemann, the change specialist hits quite precisely. On the occasion of his 50th birthday, he talks about the way to where he is today as a senior partner in AlfaNordic A/S.

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Pharma Academy

GMP Production Professional - A brand new training at AlfaNordic that provides a unique employee to a unique company. Frank Winther-Hinge, who is responsible for organizing the educational program, explains in detail here.

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AlfaNordic's customized training

Overall, it is part of AlfaNordic's strategy to be a knowledge company, and a natural basis for it is to teach the customers. In the industry there is a demand and a desire for constant continuing education, so there is a growing demand. Being able to provide teaching at a high academic level is something that really alters AlfaNordic. Teaching is always strongly linked to the practical way of working within GMP, so that it is not merely a theoretical review of paragraphs.
Christian Ilsøe, who teaches for AlfaNordic, talks about the thoughts behind the company-adapted courses at AlfaNordic

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Project: Educational Science

Trine and Simone come from educational science at the University of Aarhus, Copenhagen. It was a contact through Simone's uncle, Preben Werther, who is an external consultant for AlfaNordic and the owner of Wolfway, who caught the two eyes that AlfaNordic could be a place where they could do their bachelor project.

On a training day in November 2015, they gained insight into AlfaNordic's concept, and they agreed it could be hugely exciting to make a project. In mid-April, when they were well on their way to the project, they were interviewed by AlfaNordic Magazine.

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AlfaNordic is Denmark's fastest growing company

With a growth of 3116% in 4 years, AlfaNordic is Denmark's fastest growing company and winner of the Børsen Gazelle 2015. This is the first time that a consultancy has succeeded in winning the prestigious title of Country Winner of the Børsen Gazelle.

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Medical Devices - The Natural Path for AlfaNordic

AlfaNordic has traditionally been a competence house focusing on counseling within GMP. GMP is still the core area, but now the course is getting bigger with a new large area, with advice in medical devices. Henrik Linnemann is the current leader of the area, but the plan is for him to be just a kickstarter. Here Henrik introduces the area, but what is the idea of the whole thing in the future?

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Frank has tried a little of each

Frank Winther-Hinge is employed as Director of Strategic Compliance and Risk Management - a new area at AlfaNordic. The competencies are not new, but have previously been distributed in several departments. Increasing demand for risk analyzes for production plants in particular has now made the area a priority with a whole new business area.

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Risk Assessment - A discipline that requires experience

In 2013, AlfaNordic offers a risk assessment for Bavarian Nordic in connection with their expansion of production. It will take about 6 months, a whole lot of interviews and reading countless documents before the report is ready. It will be a report that will mean a lot to Bavarian Nordic. First, it confirms that Bavarian Nordic is on track in many respects and so illuminates the various areas which now effectively be improved before it becomes critical. Risk assessments are a discipline for the experienced gentlemen.
Thomas Meldgaard Petersen and Christian Ilsøe together with a solid team are responsible for the preparation of the report.

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From Kaluga to Kalundborg

Mai-Britt Olafsson has been employed by AlfaNordic since the fall of 2012. She is currently working on a consulting job at Novo Nordisk, Kalundborg. Her tasks include acting as a "user" in connection with the implementation of a new production line and the qualification of 2D codes.

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