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Regulations & quality and bioproduction

Level 1 -

Introduction to the culture of good manufacturing practices

Presentation

Why participate?

Raise awareness of GMP and acquire a common language to collaborate effectively with partners and subcontractors

Training Context:

Good Manufacturing Practices (GMP or cGMP) are a regulatory milestone in the development of biopharmaceuticals. While they are routine in some organizations — especially CDMOs — it is essential that all stakeholders are aware of these practices to ensure project success.

Learning objectives

  • Define and understand the origins and key challenges of pharmaceutical GMP (Good Manufacturing Practices), and what they imply for both the company and the project
  • Understand the regulatory framework governing GMP
  • Embrace the spirit of GMP and the core concepts from the main GMP chapters, in order to develop a shared language with industry partners and subcontractors
  • Understand how product/process lifecycle, risk assessment, traceability, and data integrity are integrated into GMP
  • Gain a synthesized overview of GMP as applied to advanced therapy medicinal products (ATMPs)

Content

  • Introduction to Pharmaceutical GMPs
    Definition
    Context
    Origins
    Objectives

  • Other regulatory texts
    Introduction to additional relevant regulatory guidelines

  • GMP implementation worldwide and regulatory structure
    Overview of international GMP regulations
    Comparison of regulatory frameworks and requirements

  • The 9 core GMP chapters
    General overview
    Key concepts covered in each chapter

  • Integration of quality tools within GMPs
    Product / process lifecycle
    Quality by Design (QbD), Process Analytical Technology (PAT), Quality Risk Management (QRM),
    Quality Target Product Profile (QTPP), Target Product Profile (TPP)

  • Risk-based management approach
    Introduction to risk assessment methodologies and their application in GMP

  • Traceability and data integrity in GMP
    Traceability
    Data integrity

  • Specific considerations for Advanced Therapy Medicinal Products (ATMPs)

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

Business leaders, R&D researchers, engineers, pharmacists, CSOs, project managers, academic researchers and engineers.

Prerequisites

Have knowledge of drug development processes

Duration

1 day, 7 hours

Price

750 € HT (Public)
600 € HT (Membre)
300 € HT (Académique)

Prices: Excluding tax, as the training is not subject to VAT.
In-house training rate: Please contact us.

Trainers

Huant Jérémy

Jeremy

HUANT

Business Unit Director
AGILAE Qualie

Rating

There is no rating available because this training session was never carried out.

The benefits of our courses

  • Personalized support
  • Skills assessment
  • Certificate of completion
  • Training quality evaluation
  • Accessible to people with disabilities (please contact us)

How to access and deadlines

Registering online or by e-mail is a pre-registration. We will process your request within one week:

  • Contact by e-mail or telephone
  • Sending of administrative and educational documents: training agreement, training programme and positioning questionnaire.

Signing the training agreement commits the company or individual to the training course. Cancellation conditions are specified in the training agreement.

When no session date is specified, pre-registration allows us to note your interest in a programme, and we will keep you informed as soon as a new session is organised.

For more information, contact Daphné Brisard: 02 47 36 63 18 or formation@mabdesign.fr