Webinar content

In this webinar we will provide the answers to the following questions:

Which is the regulatory background to be considered?
Main differences between remote and face-to-face audits?
Methodology to conduct efficient and successful remote audits
Evaluation of the trustworthiness of the audit

The main purpose of the audits is to ensure that the audited supplier performs the operations in accordance with the agreements and regulatory requirements; these operations are carried out under a Quality System that guarantees the absence of risks for the patient.

From AFA, we provide the necessary information and conclusions to enable QPs taking objective decisions, which can also be defended and justified in front of the Health authorities.

As we have been informing you, AFA has been dynamically adapting its methodologies and procedures to the needs and possibilities to carry out audits. Bearing in mind the current evolution of the COVID pandemic and the persistent difficulties in mobility and access to the facilities of the companies to be audited, we have developed and optimised the methodology to carry out remote audits.

This methodology establishes the performance of the audit in two phases: a first phase, in which the relationship with the auditee is based on the exchange of information and documents based on requirements established for each audit, depending on the information available to us (former audits and CAPA) and the type of products and processes. At the end of this first phase, the agenda is prepared for telematic meetings that constitute the second phase of the audit.

Once completed the audit exercise, the trustworthiness of the audit is determined through a risk assessment methodology, which yields, as one of the main outcomes, the recommended period of validity of the report and the ongoing actions to carry out.

In this Webinar we will provide you real and contrasted experiences about the remote audits’ performance in an efficient way to guarantee the success.

Target group

Qualified Persons, Auditors and QA officers.

Speaker’s background

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 (www.tdvct.com) from 2016 and lead auditor in Asociación Fórum Auditorías (AFA) from 2017 (www.forumauditorias.org ). More than 60 worldwide audits personally performed to suppliers and manufacturers of Pharmaceutical and Chemical Industries.