Pharma

Viral Clearance online masterclass will give an overview of the sources and impacts of viral contaminations of biotherapeutics.

 This training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become more and more complex.

This MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation.

The Online training Course's goal to cover the technical and organisational requirements and procedures of pharma and healthcare packaging and technical operations in a 360-degree coverage.

This public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products.

The focus of this online training is on the ICH guideline Q6B.

 This online training will present you cleaning and cleaning validation in the life cycle of a pharmaceutical product.

This training will explore the key aspects of the pharmacovigilance audits, from planning audit programmes, conducting audits to delivering audit findings through reports.

This Online MasterClass will provide best understanding on how process validation for biotechnological products, which is the collection and evaluation of data from the process design stage through commercial production.

This 1 day online masterclass gives practical examples from method validation and method transfer. The new draft ICH guideline for method validation ICHQ2(R2) has been published for comment.

This Online Training will provide how to develop and lead your organisational SAM/KAM strategy and through best practice tools and techniques.

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

This Masterclass aims to provide the key rules to ensure data protection compliance for clinical trials while offering practical guidance and best practices face to real-live examples encountered in the conduct of EU-wide clinical trials.

ICH E8(R1) Masterclass is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice

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

This Masterclass will train you in CRO oversight, and teach you how to design and implement the systems your company needs.

This Master Class will not only introduce ICH Q9 and its practical meaning, but will focus heavily on Quality Risk Management implementation in an up-to-date Quality System including many real-life examples. 

The aim of a Risk Management plans and its Implementation Masterclass is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks. 

This MasterClass provides especially information for employees in pharmaceutical/biotech industry supervising the performing of Clinical Trials by CROs. Also employees “from outside Europe” get insights as how to run and supervise Clinical Trials in “Europe”.

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

This specialized online training event will address the particular issues which affect Pharmaceutical Mergers and Acquisition work.

In this training, we will look at Basic Principles of Computerized Systems Compliance using ISPE’s GAMP5 Version 2 industry guidelines, compared to FDA’s Title 21 CRF Part 11 regulations, and EU’s Eudralex Volume 4 Annex 11 guidelines.

The Entry Level CMC Masterclass covers the general requirements for small molecules and biologics.

In this Master Class, we will review the current trends, including in technology and in FDA compliance and enforcement.

This training summarizes the current regulatory requirements to perform a structured assessment of cross-contamination risks.

This training is to wake the hidden part of your knowledge around the strong capabilities for successful implementation of you LCM projects.

In this training course you will learn about the correct use of official (pharmacopoeial) standards and regulatory requirements.

This MasterClass will provide best understanding on how process validation for biotechnological processes, which is the collection and evaluation of data from the process design stage through commercial production.

This Masterclass aims to provide the rules around the rights of the data subjects and the way to prepare to the sector of clinical trials and scientific research.

 This online training will present you what is meant by “Contamination Control Strategy”?

This 1 day online masterclass gives practical examples from method validation and method transfer.

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