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The GMPs and the Audit approach

Speakers : Pierre CHAZELLE or Pierre DEVAUX
Length : 14 hours (2 days)
Dates : 22 and 23 October 2024
Price : 1200

Training

Type of training

In-house or inter-site

Target audience

Head Pharmacist, Quality control managers and technicians in the pharmaceutical, biotechnology, human and animal healthcare industries.

Pre-requisites

no pre-requisites

Training accessible to people with disabilities

Yes

Teaching goals

  • Identify the general content of GMPs
  • Understand the principle of Quality Risk Management
  • Identify the methods used during a Quality Audit (preparation, audit plan, conduct, report and follow-up of the audit)
  • Understand the right behaviours 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) pursuant to ICH Q9 in Part III of the GMP.
  • Describe the requirements of Chapter 1 of Part I: Pharmaceutical Quality System
  • Describe the requirements of Chapter 2 of Part I: Personnel
  • List any audit discrepancies to describe the content of Chapters 3 and 5 of Part I: Premises and Equipment; Production
  • Define the necessary quality documentation and understand its management in accordance with Chapter 4 of Part I: Documentation.
  • Identify the main points specific to control laboratories by using trainer feedback pursuant to chapter 6 of part I.
  • Combine Chapters 7, 8 and 9 of Part I to introduce the principle of quality auditing.
  • Identify the key points defined in Annexes 15 and 16 of the GMPs: Qualification and Validation; Certification by a Head Pharmacist and Batch Release.
  • Describe an audit process with the stages of preparation, audit plan, conduct, reporting and follow-up of the audit and the right behaviours to adopt and mistakes to avoid.
  • Analysis of a concrete audit example
  • Open questions GMP

How the course is organised

Teaching and technical tools

  • Training materials.
  • Theoretical presentations, examples of concrete cases
  • Practical application exercises
  • Question and answer sessions
  • Self-assessment using a grid

Tool for monitoring the implementation of the training results assessment

  • Attendance sheets.
  • Knowledge acquisition assessment test
  • Certificate of training.

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 training takes place in our premises located at 16 rue Sainte-Marguerite – 21200 Beaune. Sessions start at 9 a.m. and end at 5 p.m.

Our training courses are accessible to people with disabilities. For people with reduced mobility, please contact our Handicap representative, Maryline PERRAUD: 03.80.25.94.30.

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.

Terms of cancelation

In the event of withdrawal by the beneficiary before the start of the training program: Within more than 1 month before the start of the training: 50% of the cost of the training is due.

Within a period of between 1 month and 2 weeks before the start of the training: 70% of the cost of the training is due.

Within a period of less than 2 weeks before the start of the training: 100% of the cost of the training is due.

In the event of a cancellation of less than 2 weeks, following the current health crisis linked to COVID-19, upon presentation of medical proof, the amount of the training is not due.

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.

Practical information

  • Contact :

For any information, you can contact:

Maryline PERRAUD, Disability Representative
Séverine LAURY, Administrative Referent

Elodie PASTRE and Pierre DEVAUX, Educational Referents

Phone : 03.80.25.94.30

Mail : contact@theraxel.fr

Courrier : 16 Rue Sainte-Marguerite – 21200 Beaune

Opening hours : from monday to  friday  – 9 am to 5 am.