Webinar content

The synthesis of APIs has, in many cases, many stages before the active pharmaceutical substance is obtained.

The Drug Master File defines the part of the process that must consider compliance with GMPs and is associated with the registration of the drugs that incorporate it.

In many cases, this GMP process begins near the end and, therefore, in recent times the Health Authorities require control and audit of the stages leading to the so-called Registered Starting Materials (RSM).

Audits of RSM manufacturers have the difficulty of not having a clear regulatory framework of reference and must be carried out based on risk.

In this Webinar we will share the accumulated experience of having carried out more than 60 audits of RSM manufacturers and that will allow us to provide you with clear criteria to be able to carry out a logical and effective audit approach.

Overview about the entire API process and identification of intermediates, registered starting materials, GMP intermediates and API.
Risk criteria and identification of the risk factors and their justification.
Risk based audits methodology and performance.
Most common observations.

Target group

Technical staff from API, and Pharmaceutical industry.

Speaker’s background

Dr. Eduard Cayón

AFA Director

Ph.D. in Organic Chemistry. More than 25 years of professional experience developed in Chemical Research, Pharmaceutical Analytical Development, Pharmaceutical and Food Quality Control, Validation, Auditing and Quality Assurance for the Pharmaceutical industry.

Since 1999, working as a Consultant for Pharmaceutical industry in TDV (www.tdvct.com ), giving services to customers from several European and Asian countries.

Founding partner, Vicepresident and Director of Asociación Fórum Auditorías (AFA) from 2005 (www.forumauditorias.org ). More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical and Cosmetic industries.