Regulations & quality and bioproduction

Level 1 -

Introduction to data integrity concepts in the biopharmaceutical industry

Presentation

Why participate?

Understand the challenges of data integrity and ensure its control within a biopharmaceutical process.

Training Context:

Data integrity concepts are often intuitively understood and applied — sometimes inconsistently or incorrectly. However, mastering data integrity is the first step toward building a complete and robust quality system. The stakes are high: it concerns the security of sensitive data (protocols, reports, research results, bibliographic references, QC records, patient data, employee information…), as well as their traceability, reliability, readability, and archiving.

Learning objectives

  • Define and understand the fundamentals of data integrity
  • Learn about the regulatory and operational environment surrounding data integrity
  • Identify the key challenges and risks related to data integrity
  • Understand the basics of a robust system to manage data integrity risks

Teaching methods

Interactive Teaching, Case Studies, Experience Sharing

Audience

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

Prerequisites

No prerequisites required

Duration

4 hours

Price

430 € HT (public)
€340 (member)
€170 (academic)

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

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