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The Management of Particulate and Microbial Contaminants in the Production of Sterile and Non-Sterile Drugs

Réf. : THF2

Speakers : Pierre DEVAUX or Elodie PASTRE
Length : 14 hours (2 days)
Dates : 11 and 12 June 2024
Price : 1200

Training

Type of training

In-house or inter-site

Target audience

Management and support service staff (production methods, qualification/validation, maintenance, microbiology laboratory, etc.),

Pre-requisites

no pre-requisites

Training accessible to people with disabilities

Yes

Teaching goals

  • Identify applicable international standards
  • Identify particulate and microbial contaminants causing discrepancies at their site
  • Identify all the elements in the ZAC (HVAC, personnel flow, material flow, zone layout, etc.).
  • To know the Qualification/Classification terms and especially Monitoring terms to ensure participation in field investigations in the case of proven contamination.
  • Integrate behavioural requirements (hygiene, dressing and activity in ZACs) to be put into practice on a daily basis and in accordance with the role (practices described and adapted depending on the group)
  • Integrate the specific features of the different set-ups used for aseptic filling and alternative processes
  • Identify the cleaning and disinfection operations of the premises

Content of the training course

  • Identify the international texts available for the management of particulate and microbial contaminants,
  • Define, characterise and categorise the different types of contaminants,
  • Describe the different elements which make up a ZAC to be able to identify the risks of contamination in your ZACs in situ,
  • Remember the key points of the Qualification, Classification and Monitoring strategies to arrange an investigation and interpret the associated results,
  • Discuss the general hygiene measures and dressing practices to be implemented in your activities to manage ZAC entrances,
  • Adopt good behavioural practices consistent with your activities,
  • Distinguish between the different set-ups that can be used to manufacture sterile drugs,
  • Describe proper aseptic practices for Class A and understand the expectations of the aseptic simulation process,
  • List the main stages of a process for decontaminating the non-critical surface of the premises and understand the associated issues as regards environmental monitoring.

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.