Training courses
The life science industry in Norway is growing, and it is important for the industry to find motivated employees with the right competence and understanding. SurViva is offering tailored training courses where an important objective is not only to see what regulatory requirements are about, but also to grasp why regulatory standards have been developed, and how they add value to the end users and to society. Only by understanding the overall objectives of regulatory and quality requirements, employees will be motivated to do their best to comply with the standards.The training course can be tailored for the audience but will normally start with a general introduction to the regulatory environment for the food, medical device and/or pharma industry. The course will present definitions of different types of products in life science, i.e. what are the definitions of drugs, medical devices and food / cosmetics. To be able to classify products correctly is crucial for companies during product development, and for some types of products this is really challenging.
The course will further describe relevant regulatory requirements and quality standards in general terms and will specifically look into the regulatory requirements and the quality standards applicable during the various phases of product development. The course will also point to the relevant regulatory bodies and give the students tools and tips on how to find relevant information at a later stage.
The course will further present the concepts of quality management systems, and to give the students background understanding why quality systems are useful, and how they help businesses deliver according to expectations from customers, patients and the society.
eQMS (electronic quality management system)
SurViva has expertise in BizzMine, a flexible and user-friendly software for controlled handling of documents and business processes. The tool is compliant with all common regulatory standards, and is designed for handing QMS activities such as management of change and deviations and non-conforming product.
We have already established lean modules for several business processes, which can be used as template for individual businesses. This eQMS tool is easy to further adapt within a growing company, and SurViva can customise the platform to the customer’s needs and assists with implementation and training.
eQMS (electronic quality management system)
SurViva has special expertise in BizzMine, a flexible and user-friendly software for automating company processes, for growing companies. We assist with arranging the tool for the company’s needs, as well as with practical implementation and training.
Astrid Hilde Myrset is project manager for The Life Science Cluster’s eQMS project, which has chosen BizzMine as software supplier. By participating in this project, TLSC members can gain access to proven quality modules and existing SOPs.
Quality assurance
Companies that want to start a regulatory development course must establish a quality system and Standard Operating Procedures (SOPs) for all the company’s processes and methods. SurViva has expertise within quality assurance and assists companies in establishing a quality management system (QMS) that is required when moving from the early laboratory research to structured development.
Companies developing Medical Device (MD) will need the first components of a QMS already during planning of product realisation and must be certified according to ISO 13485 and Medical Device Regulation (MDR) before going to the market. We can assist with this path and provide training and support in connection with audits both internally and externally.
Quality assurance
Companies that want to start a regulatory development course must establish a quality system and Standard Operational Procedures (SOPs) for all the company’s processes and methods.
Turid Koksvik Høysæter has special expertise in quality assurance, and SurViva assists companies in establishing a quality system and other systems that are required when going from the laboratory to the market.
Laboratory services
SurViva assists with Health, Safety and Environment procedures for our local customers and can provide lab facilities at Fornebu. We also provide practical lab services to customers.
