Part 2 cGMP - Organisation, Personnel and Infrastructure
Dernière mise à jour : 28/10/2025
Description
Aucune description
Domaine : MEDICAMENTS, DM
Objectifs de la formation
Objectives:
- Understand regulatory requirements regarding the organization of activities, personnel qualifications, and infrastructure necessary for the manufacture of pharmaceutical products;
- Understand the importance of training, experience, and skills required to ensure the quality, safety, and efficacy of pharmaceutical manufacturing operations;
- Understand the requirements for pharmaceutical infrastructure and facilities according to cGMP, including facility design, necessary equipment, safety measures, and quality management procedures.
Public visé
Anyone involved in the production and control of medical devices. Human Resources, QMS Manager.
Prérequis
No prerequisites
Programme
Topics covered:
- Organization and personnel (organization, qualifications, and responsibilities of personnel)
- Buildings and facilities (design and construction characteristics, ancillary areas, and cleaning)
- Equipment (design, cleaning, and maintenance of equipment, calibration, automatic, mechanical, and electronic equipment)
Modalités pédagogiques
Interactive module consisting of expert videos, educational activities, etc.
Moyens et supports pédagogiques
Once you have placed your order, you will first receive an order confirmation email.
You will then receive confirmation of access to the module on our TREENING platform. This access is personal and secured by a password.
The TREENING Support Service is available to answer any technical or functional questions you may have.
If you have any questions specific to the module's subject matter, you can contact us via the discussion forum. One of our experts will respond as soon as possible.
At the end of your training, you will be invited to complete a satisfaction survey and, if applicable, download a training certificate.
Modalités d'évaluation et de suivi
- Multiple-choice assessment test
- Training certificate: yes
- Satisfaction survey
Infos complémentaires
- Module validity: 1 week after receipt of payment (extension possible)
- Training certificate: yes
- For orders of more than 10 modules, contact the training department for a personalized quote: [email protected]