On-line Advance Training Session

In 2004 APIs were defined as the critical raw materials to be audited. Do we really audit the GMP compliance, or we just believe their speech? Is that a critical activity or a commodity?

In this on-line course, the real GMP auditing criteria for API manufacturing will be reviewed.The following topics will be covered:

Regulatory framework
Manufacturer profiles. Typical API manufacturing process
Audit approach; post-audit actions and follow-up

The manufacturing and control of these products are subject to Good Manufacturing Practice (GMP) to ascertain the quality and safety for the patient and to obtain reliable and integer data to support its qualification.

Examples of most common observations will be shown during the course, and it will be enabled a space for questions and answers.

Target group

Professionals opearting in the Pharmceutical business wishing to improve their resources and knwoledge on performing effective supplier audits.

Speaker’s background

Dr. Eduard Cayón

AFA Director

Ph.D. in Organic Chemistry. More than 30 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. Founding partner and Director of AFA from 2005. More than 300 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical, Chemical, Biotech and Cosmetic industries.