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Managing Cross-Contamination in the Healthcare Industry

Réf. : THF3

Speakers : Christophe GAMBLIN
Length : 14 hours (2 days)
Dates : 27 and 28 March 2024 18 and 19 June 2024 or 19 and 20 November 2024
Price : 1200

Training

Type of training

In-house or inter-site / Classroom-based or remote

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

  • Understand the regulatory requirements on the subject at the European GMP level
  • Understand the difference between Particulate, Microbial and Pyrogenic Contamination Management as described in Annex 1 and the Management of Cross-Contamination as described in Chapters 3 and 5 of Part I of the European GMPs and its Annex.
  • To be able to build risk analyses for managing cross-contamination adapted to and linked to the manufacturing process used
  • Incorporate CAPAs suggestions based on the trainer’s experience feedback
  • Identify the theoretical and practical aspects of the cleaning validation process
  • Understand the general differences between cleaning equipment compared to cleaning and disinfecting premises

Content of the training course

  • Refer to the different international regulatory texts and Association texts (PDA, ISPE, A3P, WHO, PIC’S…)
  • Describe the general content of the European GMPs
  • List the different contaminants
  • Define the concept of Cross-Contamination
  • Define the EDP approach
  • Understand and interpret the documents: EMA, CHMP, CVMP, SWP, 246844, 2018
  • Explain the Quality Risk Management approach described in the ICHQ9 and included in Part II of the GMPs
  • Describe and discuss an example of an analysis put in place by the trainer on the topic
  • Identify general approaches to Validation
  • Understand the issues involved in Cleaning Validation
  • Describe the general approach to the Cleaning Validation process
  • Understand the regulatory expectations of Chapter 10 of Appendix 15
  • Review in detail 3 topics related to Cleaning Validation: QbD approach to the cleaning process; visual inspection; manual cleaning and operator training, certification and qualification.

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.
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 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.