Managing GMP audits

Intervenant(s) : Pierre CHAZELLE or Pierre DEVAUX or Laurent MERLI
Length : 14 hours (2 days)
Price : 1200
Trained people : 2025 - no session

Trainings EN

Type of training

In-house or inter-site

Target audience

Responsible Pharmacist, Quality Assurance Managers and Teams, Production Managers and Operators, Managers and support services teams (Utilities, Industrial Transfer, Qualification/Validation...), Quality Control Managers and Technicians within the pharmaceutical, biotechnological industries whether in human or animal health

Pre-requisites

no pre-requisites

Teaching goals

  • Identify the general content of GMPs
  • Understand the principle of Quality Risk Management
  • Identify the modalities of a Quality Audit (preparation, audit plan, process, report and audit follow-up)
  • Understand the right behaviors to adopt and the mistakes to avoid

Content of the training course

  • Describe the general content of the GMPs (Parts I to IV and Annexes)
  • Explain the principle of Quality Risk Management (QRM) according to ICH Q9 in Part III of the BPF.
  • Describe the requirements of Chapter 1 of Part I: Pharmaceutical Quality System
  • Describe the requirements of Chapter 2 of Part I: Personnel
  • Cite audit deviations to describe the contents of Part I, Chapters 3 and 5: Premises and Equipment; Production
  • Define the necessary quality documentation and understand its management in accordance with Chapter 4 of Part I: Documentation
  • Identify the specific points specific to control laboratories by benefiting from feedback from the trainer in accordance with Chapter 6 of Part I
  • Group Chapters 7, 8 and 9 of Part I to introduce the principle of Quality Audit
  • Identify the key points defined in Annexes 15 and 16 of GMP: Qualification and Validation; Certification by a Responsible Pharmacist and Batch Release
  • Describe an audit process with the steps of preparation, audit plan, conduct, report and audit follow-up and the good behaviors to adopt and the errors to avoid
  • Analysis of a concrete audit example
  • Open-ended questions BPF

How the course is organised

Teaching and technical tools

  • Training materials.
  • Theoretical presentations, examples of concrete cases
  • Practical application exercises
  • Question and answer sessions

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Assessment tests of the acquisition of knowledge
  • Certificate of training.
Download the training file

Registration and formalities

Registration

For all intra or inter-company registrations, please send your request to the following email address : contact@theraxel.fr .

An acknowledgment of receipt of your request will be sent to you as soon as possible

Training place

Our open-enrollment courses can be offered in Beaune (21200) or Dijon (21000).

For in-house training, please contact us.

Registration conditions

A minimum of 5 participants is required for the training to be provided. Below, THERAXEL reserves the right to postpone the scheduled session.

Upon receipt of your registration, Theraxel will send you an acknowledgment of receipt. The training agreement will be sent to you at the latest 1 month before the start of the training.

After the training has taken place, we will send you the invoice as well as the training certificate. From the date of issue of the invoice, payment must be made within 30 days at the latest.

Our prices

All prices are indicated in euros excluding taxes. The applicable VAT rate is 20%.

The prices indicated are in effect for the current year, and applicable for inter-company training.

The prices indicated are per participant and include the educational cost of the training, materials, lunch and breaks.

For intra-company requests, the request will be the subject of a personalized quote adapted to your needs. Contact us for more information.

People with disabilities

Accessibility for people with disabilities:

If you have a disability or are experiencing difficulties, you can contact our contact person: Maryline PERRAUD, at 03.80.25.94.30, so that we can study your request and adapt the form and content of the teaching methods implemented.

Practical information

  • Contact :

For any information, you can contact:

Séverine LAURY, Administrative contact person for the training department

Maryline PERRAUD, Disability Representative

Elodie PASTRE and Pierre DEVAUX, Educational Referents

Tél : 03.80.25.94.30

Mail : contact@theraxel.fr

Courrier : 16 Rue Sainte-Marguerite – 21200 Beaune

Sur place : du lundi au vendredi de 9h à 17h.