Public courses

How do you know you have quality if you cannot reliably measure what you are doing? Are you afraid of complex statistical concepts and procedures? These two webinars will help you to evaluate your measurement systems, diagnose problems, and fix them. How is it “made easy”?

This second webinar will focus on Attribute Measurement Systems – that is, the subjective inspection of items to see if they satisfy requirements. Since humans are the “gauges”, attribute measurement systems can have high variation. How do you evaluate this human judgement and how can you improve their results? And how is it “made easy”?

Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.

This tailor made training gives you the tools and skills required as Auditor or Lead Auditor in the Pharmaceutical and Medical Device industry.

This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics -- all the time.

Learn how to plan perform and report internal MDSAP audits as well as best practice and tools how to be prepared to undergo or perform MDSAP audits.

This practical masterclass helps AI start-ups, medical device manufacturers and development teams determine when software qualifies as a medical device, plan EU market access, build proportionate quality and technical documentation, and define the clinical evidence needed to support intended purpose, claims, safety, performance and clinical benefit.

An overview of QRM and RCI and the respective regulatory expectations. Common tools and methods for the Pharma and Medical Device industry.

This fast-paced webinar will cover the details of application of Sampling without the burden of statistical complexity.

Learn how and when a biological evaluation, according to ISO 10993-1, should be performed. Understand the evaluation requirements and avoid common pitfalls!

Learn how to accelerate medical device development, approval, and post-market activities with compliant use of LLMs.

Learn details for all part of the global cleaning validation strategy in pharmaceutical activities. CGMP expectations, technical and regulatory updates.

Utbildning om de FDA och EU-regler och tolkningar som berör datoriserade och automatiserade system vid läkemedelstillverkning: 21 CFR 11 och EU GMP Annex 11

How to have your Medical Devices compliant with the cybersecurity requirements: risk management, design, development, maintenance, and post-market surveillance.