Pharma

Microbiological contaminations can occur on many levels.

Key elements for a successful development of a drug product analytical development

 The MasterClass will cover aspects that are relevant for non-toxicologists involved in drug development

This 2 days online masterclass gives practical examples from method validation and method transfer & pitfalls.

This intensive online training will be held over 4 consecutive half-day sessions for lawyers, and paralegals, working in the pharmaceutical industry.

Drafting the well structured, practical, clear and concise documents which achieve their objectives

The Master Cell Bank is not only the starting point of GMPs but also the starting point of the therapeutical recombinant proteins and GTP

This online masterclass will address regulatory requirements related to cell bank establishment and testing.

Pharmacopoeias play a major role in quality standards for the manufacture and control of medicines in Europe and worldwide

What the FDA is and how the entity is organized

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Learn how to define, evaluate, and respond to risks, and also how to define critical data.

Interventional studies fall into the scope of Directive 2001/20/EC and will no be the object of this Masterclass.

Guidance for conducting pesticide residue analysis, reviewing analytical results, or writing analytical reports

Focus on topics and rules with a significant practical impact on routine residue analysis

Learn more about identification and control of Leachables and Extractables

Clinical trials are the cornerstone for advancing medical knowledge by evaluating the efficacy and safety of health-related interventions

Principles, advantages and potential challenges of the adaptive design methodology

Today, process validation comprises three main steps:

Statistical impact on drug supply as well as how to properly set-up your IRT system

Statistical impact on drug supply as well as how to properly set-up your IRT system

Key points for successful development and registration of your pharmaceutical products

Quality requirements of pharma and healthcare packaging

Microbiological contaminations can occur on many levels.

Key elements for a successful development of a drug product analytical development

Mastering Drug-Device Combination Products

Components of successful project management such as interaction between project activities and key decisions will be highlighted

An advanced-level masterclass for participants with a minimum of 5-10 years of industry experience

Impurities in active ingredients, excipients, medicinal products and packaging materials

What is meant by “Contamination Control Strategy”? A complex system of measures designed to minimize the risk!

 What is meant by “Contamination Control Strategy”?

Mastering Dissolution Testing: From Basics to Advanced Techniques

Gain invaluable insights into the development, regulation, and deployment of AI-powered medical devices