Webinar content

Cross contamination is one of the most important risk for the patients derived form the manufacturing operations, specially in the multiproduct plants. The main risk reduction actions to be done are the cleaning of the product direct contact surfaces and their environment and therefore cleaning activities must be considered critical and very well controlled by correct design and daily execution and monitoring.

Correct implementation of cleaning activities in a pharmaceutical plant needs the involvement of different departments (R&D, engineering, QA, production, QC, etc.) and requires a correct application of different tools and procedures (risk assessment, methods design, records design, analytical methods, sampling methods, validation approach, personnel training, etc.).

In this Webinar we will share our knowledge and experience from having carried out hundreds of audits of APIs, finished products and excipients, in which evaluation of cleaning activities use to be a hot topic and should include:

Evaluation of different scenarios (facilities, equipment, processes, products, etc.)
Rational for cleaning process design.
Cleaning execution: procedures, guides/records, visual inspection.
Validation approach based on risk assessment .
Validation, revalidation and verifications.

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

Target group

Technical staff from API, and Pharmaceutical industry.

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.

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