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]

M'inscrire à la formation

Toutes nos formations peuvent être accessibles aux personnes en situation de handicap. Chaque situation étant unique, nous demandons à nos clients de bien vouloir préciser le handicap lors de la sollicitation. Ceci afin de pouvoir vous confirmer l'ensemble des possibilités d'accueil et permettre au participant de suivre la formation dans les meilleures conditions.

Pour toutes informations complémentaires nous conseillons les structures suivantes AGEFIPH (www.agefiph.fr), FIPHFP(www.fiphfp.fr). Nous tenons également une liste de partenaires mobilisables le cas échéant.

All our training sessions are accessible to individuals with disabilities. As each situation is unique, we kindly ask our clients to specify the disability when making inquiries. This allows us to confirm all possible accommodations and enables participants to undergo training under the best conditions.

For further information, we recommend the following organizations: AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). We also maintain a list of partners who can be mobilized if necessary.

S'inscrire
  • Catégorie : E-learning
  • Durée : 0h37m
  • Prix : 85 € HT
    Prix INTRA : Nous consulter
  • Référence : EL_BP_105_M02_EN
  • Satisfaction :
    ★★★★★
    ★★★★★
  • Taux de réussite : - %
  • Télécharger le programme

Vos formations

Les tarifs indiqués sont ceux pratiqués pour les sessions au format Inter-entreprise. Pour les sessions Intra-entreprises ou individualisées merci de nous contacter afin d'établir un devis.

The prices indicated are for sessions in the Inter-company format. For Intra-company or customized sessions, please contact us to establish a quote.

Partager cette formation

Handicap et adaptation :

Toutes nos formations peuvent être accessibles aux personnes en situation de handicap. Chaque situation étant unique, nous demandons à nos clients de bien vouloir préciser le handicap lors de la sollicitation. Ceci afin de pouvoir vous confirmer l'ensemble des possibilités d'accueil et permettre au participant de suivre la formation dans les meilleures conditions.

Pour toutes informations complémentaires nous conseillons les structures suivantes AGEFIPH (www.agefiph.fr), FIPHFP(www.fiphfp.fr). Nous tenons également une liste de partenaires mobilisables le cas échéant.

Disability and adaptation:

All our training sessions are accessible to individuals with disabilities. As each situation is unique, we kindly ask our clients to specify the disability when making inquiries. This allows us to confirm all possible accommodations and enables participants to undergo training under the best conditions.

For further information, we recommend the following organizations: AGEFIPH (www.agefiph.fr), FIPHFP (www.fiphfp.fr). We also maintain a list of partners who can be mobilized if necessary.

 

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