On-line Advance Training Session

In this on-line training we will share the accumulated experience of having carried out dozens of audits of packaging manufacturers. It will allow us to provide you with clear criteria to be able to carry out a logical and effective audit approach. It will include:

Types of packaging materials in pharma industry and their criticality. Profile of manufacturers
Regulations and guidance
Audit approach; post-audit actions and follow-up

Risks derived from manufacturers of primary packaging, such as bottles, tubes, foils, ampoules or vials are mainly based on the introduction of contaminants or degradants into the product. Risks derived from manufacturers of secondary packaging, as printed cartons, labels or leaflets, relies basically on the content of printed texts and possibility of mix-ups during production.

The need to audit packaging materials’ manufacturers has increase in last years because of the risk evaluation performed by customers. According to these risks, auditor should perform an adequate audit approach and conduct the audit doing a correct interpretation of the reference standard ISO 15378.

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

Mr. José Carlos Vergara

AFA Head of technical department

Master’s degree in Chemistry. With 17 years of professional experience in Quality Control, Quality Assurance, Validation and Auditing in different companies and different countries. Integrated in TDV from 2016 and lead auditor in Asociación Fórum Auditorías (AFA) from 2017. In 2019 José became the Head of the Technical department at AFA. More than 80 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical and Chemical Industries.