Welcome to AlfaNordic A/S - Excellence in GMP

Courses and training

From Class Room Training to after-hours meetings

AlfaNordic offers courses and training

AlfaNordic offers customer-tailored courses and training based on today’s standards within Life Science. During recent years, the Life Science industry has been confronted with changing market conditions. The demand is dominated by a swiftly changing legislation, an increasing number of rules and tightened requirements by controlling authorities as well as an increasing price pressure from authorities and consumers. The supply of medicinal products is also challenged by constant changes: Globalisation of the entire value-added chain, a growing tendency to outsourcing of the production to less salary-heavy countries, new competitors and sales channels, and the expiry of important blockbuster patents. These conditions put added pressure on the production, and old industry structures are challenged at the same time. Businesses must be willing to change in order to survive and this is where a customer-tailored course from AlfaNordic might be beneficial.

Courses and training from idea to execution

We offer broad knowledge within strategic and organisational consulting services ranging from Risk Assessment in the industry to the administration, GAP quality analyses, interim management and Guidelines for procurement – from idea to implementation.

  • QRM Risk Assessment

  • GMP in the production

  • GMP in documentation

  • Qualification and Validation

  • QC method validation

  • Medical Devices ISO13485

  • GDP

  • Customer-tailored courses

We specialise in

Customised courses 

AlfaNordic knows the challenges that the Life Science industry is facing at the moment. We help companies that operate in this industry gain awareness of changes so that the changes can be addressed to their advantage. With pharma, biotech and medical devices as our focus industry, we specialise in offering customised solutions – from Class Room Training to after-hours meetings.

After-hours meetings

AlfaNordic continuously arrange after-hours meetings discussing current subjects within GMP, Risk Management and Medical Devices. After-hours meetings are typically conducted with an introduction by AlfaNordic followed by a debate among the participants. Participation in after-hours meetings are free of charge, unless otherwise specified in the invitation. Written registration is however necessary in consideration of the physical arrangement of the event. Stay updated here on topics, dates, times and places for AlfaNordic’s after-hours meetings. After-hours meetings are currently only available at AlfaNordic’s headquarters in Herlev, Denmark. We hope to introduce them to more locations in the future.

Client Advantage

Our employees all possess a significant knowledge and experience within the pharmaceutical or biotechnological industry – both from the part of the customer and as consultants and instructors. Our consultants are all able to enter into a close cooperation with our customers. They understand the challenges that the customers are faced with and they understand how to convert them into solutions. As a consultancy house we take an active part in spotting new trends in the industry and thus breaking down barriers and developing and creating sustainable solutions for our customers.

Our sales and services process

The course of events for assignments normally goes through the following process.

1. Competency needs

The competency needs for the specified task are identified together with the customer. A sales meeting may be held. Please contact AlfaNordic sales department or an area manager.

2. Proposal and review

AlfaNordic draws up a proposal, identifies time frames and provides CVs for the task. The proposal is forwarded to the customer, followed by a review and a discussion. A meeting may be scheduled for further discussions of the proposal.

3. Contract

AlfaNordic sends the contract to the customer for approval. The contract covers economy, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic’s consultants start working on the task at the agreed date and time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and continuously hold status meetings with the customer as well as with the consultants.

6. Completion of task and customer evaluation

The task is completed within the agreed time and economy. AlfaNordic follows up with a customer evaluation form and a concluding dialogue with the customer.

QRM Risk assessment - ICHQ9

Risk management is a systematic process for assessment, control, communication and review of risks in relation to the quality of medicinal products. We use it proactively in collaboration with our customers. We hold workshops where we discuss and review critical processes, clarify problems and present suggestions for possible solutions.

Development of courses or training sessions

AlfaNordic continuously develops and conducts courses and training sessions within a wide range of topics. Please ask us whether we have experience with your particular area of business.

FMEA (Failure and Effects Analysis)

Interest in FMEA is growing. The model was developed for the military back in 1949 and was used in earnest when NASA started working with risk assessments in connection with their space programme. FMEA models are useful for creating a structure and for identifying the most alarming risks and areas that require measures to prevent a problem from occurring in the first place. The idea is to analyse potential failures and errors. These risks are systematised to illustrate the effect and probability of errors.

Management Consulting

AlfaNordic plans workshops with focus on the individual company’s most critical issues and possibilities: strategy, organisation, business, transformation and due diligence, across all industries and geographical areas.

GMP / GDP / GAP analysis

AlfaNordic holds customer-tailored courses within GMP / GDP – the courses help our customers complying with current GMP/GDP requirements which is crucial for maintaining a ”license to operate” in the pharmaceutical and biotechnological industry. We conduct GAP analyses based on the current state of daily routines, operation, applicable requirements and our points of reference are examples from the individual company’s everyday work life.

Audit training

AlfaNordic offers internal audits to the individual company, and based on audit examples and findings, we plan, develop and conduct training for our customer.

Our customer evaluations

from previous tasks

Average customer evaluations for completed tasks. Grades applied according to a scale of 1 to 5:

  1. Unacceptable
  2. Less acceptable
  3. Acceptable
  4. Good
  5. Very good
GMP training in 2015
Projects in 2015
Risk Assessment in 2014

Contact our course and instructor team

Do you want to know more. Do you have competency inquiry or request. Or maybe you want to present us with a challenge? You are always welcome to contact one our area managers. They are ready to answer your questions.

Christian Ilsøe
Co-owner, Board Member & Senior Consultant

T: +45 5152 9030

Annette Myrup
Education & Training Coordinator

T: +45 2888 4090

Preben Lind Hansen
Business Development

T: +45 6146 2340

Frank Winther-Hinge
Managing Director, AlfaNordic Academy

T: +45 5059 1598