Active Substances and Excipients for Medicines - Rules and Requirements

[Joseph Wilcox]

Quality Assurance, Quality Systems, quality risk management and Quality Control are the cornerstones of Good Manufacturing Practices (GMP). Being a globally acclaimed provider of training courses for professionals, Traininng.com introduces these concepts at this online regulatory compliance training webinar.

The expert, Dr Madeleine S. Fairweather, will present these concepts in accordance with EU GMP Part II. However, since most organizations are likely interested in the markets beyond Europe, such as the USA, Australia, Asia or Japan; she will show how to align their Quality Systems with other international guidelines such as ICH Q7 for current Good Manufacturing Practice of APIs.

Dr. Fairweather will also make a detailed discussion of the ICH Q11, which deals with the development and manufacture of chemical, biotechnological and biological components of drug substances. Another topic she will explain includes what criteria need to be met when it comes to releasing these materials for shipping and further processing.

Online regulatory compliance training for ensuring successful API and excipient sourcing and manufacture

The core of the discussion in this online regulatory compliance training is about the general rules and regulations that must be adhered to in order to ensure successful API and excipient sourcing and manufacture. Dr. Fairweather will discuss the different types of substance and the rules which apply to each and when and how thoroughly to apply cGMP to the phases of manufacturing. Also covered in detail at this webinar are labeling requirements and batch supply chain and considerations for commercially licensed active substances versus APIs for use in clinical trials.

This online regulatory compliance training from this well-known provider of training courses for professionals is aimed at all those whose work involves some element of familiarization with the rules and requirements for selecting, purifying and manufacturing of active substances (active pharmaceutical ingredients or APIs) and excipients for use as starting materials in the manufacture of human or animal medicines.