On-line Advance Training Session

In this on-line training 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:

Main sources of contamination and cross-contamination
Severity of contamination risks according to types of processes and stages. API, Excipients and Medicines
Cleaning as risk reduction measure
Clues to evaluate the cleaning method and the cleaning validation approach

Presence of undesirable contaminants in pharmaceutical products resulting from cross contamination is one of the most important risk for the patients derived from the manufacturing operations, especially in the multiproduct plants. The main risk reduction actions to implement and control are the cleaning activities to equipment with direct contact with the product. 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.).

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. Juan Torrijos

AFA auditor and TDV senior consultant

Chemical Engineer UAB. Industrial experience in Quality Departments in the food industry. Subsequently, after 10 years of experience in TDV, his activities have been developed in the field of consultancy to companies in the chemical-pharmaceutical and cosmetics sector, specialising in projects of validation of computer systems associated with production processes. Qualified Auditor of the Forum Auditorias to carry out audits of suppliers of APIs, Excipients, Packaging Manufacturers, logistic services and analytical services. Operations Manager at TDV - China.