Control of Contamination

Contamination control by ZAC
(Sterile and non sterile)

MC08

Date

9 and 10 2018 October

14 h face-to-face

Effective work

Formative

Pierre Devaux

17,2
/ 20

Price

1200 € HT

(Lunch included)

Objectives

- Master the application of the GMP's for the manufacture of sterile products in clean rooms (from class D to classes A / B) and know the main standards applicable to your activities and the operation of a ZAC.
- Apply Good Aseptic Practices according to the situations encountered in clean rooms.
- To positively appraise the results of particulate and microbiological controls carried out on your premises and to be able to help Quality Assurance in operational investigations following contamination problems.

Public

  • Beginner
  • Intermediate
  • Expert

- Manager of production and maintenance teams
- Production and maintenance operator
- Microbiology laboratory technician carrying out environmental controls in clean rooms
- Technician of the utilities intervening in clean rooms

Programs

Regulatory point with a focus on the following standards:
Appendix 1 subject to interpretation and therefore PIC'S PI032-2, GFI Aseptic Process 2004, PDA TR62 and USP <1116>

The different contaminants and cross contamination:
Particles, microorganisms, chemicals and static electricity

1 - The process of contamination

Operation of a clean room:
Other industries are also concerned and the fragility of the various barriers including the quality of the air filtration and the maintenance of the overpressure (see depression in some cases) must be known.
Special case of aseptic repair with a focus on different configurations:
Class A distribution in B, use of RABS and use of isotechny.


2 - Classification and monitoring of clean rooms

The various tests to classify your premises and in particular the smoke tests, return on the "specifications described in the Appendix 1" and on the new version of the USP <1116>, explanation of the different methods of sampling (operation of a meter particulate matter, air samples using impinging aerobic sensors, collection on gelatin and transfer, update on the latest developments in the field, sampling of surfaces by swab, contact agar, exposed boxes, glove controls) and the interpretation of the results transmitted.


3 - Staff and Material Flows

Operation of different SAS:equipment, personnel and consumables
Clothes used in clean rooms
Personal hygiene: hand washing and dressing procedures according to classes


4 - Great Principles on Behavior and Behavior for Good Aseptic Practices

  • In class C and D
  • In class A / B and B

Focus on Media Fill Tests

The main principles of bio-cleaning in clean rooms

Assessment of acquired knowledge and evaluation of improvement actions undertaken and / or envisaged

Questionnaire de satisfaction

To download the program of this training in PDF format, please click on the button below.

Program PDF version

Cette journée s’inscrit dans le cadre de la formation professionnelle.
N° Déclaration : 82 69 13448 69 Préf. Région Rhône-Alpes
SARL au capital de 10 000 Euros Siret 451 934 541 00025
* Average score given by previous trainees

DEVAUX

Pierre DEVAUX - UPS CONSULTANTS

Expert in contamination control, he carries out audit, consulting and training missions for the health industries within UPS Consultants around the following topics:
  • validation of the cleaning,
  • cleaning the premises,
  • Good Aseptic Practices,
  • implementation of risk analyzes to control the contamination of manufacturing processes,
  • GMP audits and investigation of product contamination issues.

Educational medium

At the beginning of the session, through a questionnaire, the trainer analyzes the level of knowledge of the professionals on the subject as well as their expectations of the knowledge to be acquired. The trainer adapts the training program according to the profile of the different participants. Time is spent exchanging experiences between participants and with the trainer.

Pour un bon suivi du stage, le stagiaire dispose d’un ou plusieurs supports de cours en version numérique et en version papier.

Referencing the DataDock

Single database that refers to training organizations that meet the criteria established by the funders.
Evidence of the proper application by the structures of the criteria set by the quality decree. The latter specifies how the training funders (OPCA) must ensure the capacity of the training organizations to provide quality training actions.

This referencing certifies the quality of our training according to 6 criteria and 21 indicators defined at national level by the funders.
Guarantees :
- The precise identification of the objectives of the training and its adaptation to the trained public.
- Adaptation of the reception, pedagogical monitoring and evaluation systems to trainee audiences.
- Adequacy of pedagogical, technical and supervisory resources to the training offer.
- The professional qualification and the in-service training of the staff responsible for training.
- The conditions for informing the public about the training offer, its access times and the results obtained.
- Taking into account the assessments made by trainees.

To register for this training, please return the registration form.

All our courses take place at 30 rue Pré-Gaudry in Lyon 7ème and start at 8h30 and end between 17h and 18h.

Contact

According to your requirements and your preferences, you can contact Marion Provini:

Phone: +33 (0)4 37 28 30 49
Fax: +33 (0)4 37 28 30 60
E-mail : mprovini@a3pservices.com
Mail: A3P Training, 30 rue Pré-Gaudry - Lyon 69007
On site: 30 rue Pré-Gaudry, Lyon, from Monday to Friday

Accessibility

50

Hotels nearby

Hotels **

Séjours & Affaires Hotel - Park Avenue
2 rue Madeleine Fourcade, 69007 Lyon - Tel: + 33 (0) 4 37 65 59 59
5 min walk
Offer Training A3P

Appart City Lyon - Part Dieu Villette
6 Avenue Lacassagne, 69003 Lyon - Tel: + 33 (0) 4 37 91 99 21
4 metro stops (Part Dieu)

Hotel Séjours & Affaires - Saint Nicolas
90 Boulevard Vivier Merle, 69003 Lyon - Tel: + 33 (0) 4 37 48 24 24
4 metro stops (Part Dieu)
Offer Training A3P

Hotel Séjours & Affaires - Saxony Gambetta
34 Great Street of the Guillotière, 69007 Lyon - Tel: + 33 (0) 4 72 71 91 92
2 metro stops (Saxe Gambetta)
Offer Training A3P

Hotels ***

Park And Suites Lyon Gerland
175 avenue Jean Jaurès, Lyon 69007 - Tel: + 33 (0) 4 37 37 25 25
5 min walk

Mercure Lyon Beaux Arts Centre
73-75 rue du Président Edouard Herriot, Lyon 69002 - Tel: + 33 (0) 4 78 38 09 50
30 2 min (2 different subway lines)

Hotels ****

Novotel Gerland
70 avenue Leclerc, 69007 Lyon - Tel (+ 33) 4 72 71 11 11
20 min walk

Quality Suites Lyon 7
Felix Brown Street 7, 69007 Lyon - Tel: + 33 (0) 4 37 37 23 70
3 min walk

Novotel La Part Dieu
47 boulevard Vivier Merle, Lyon 69003 - Tel: + 33 (0) 4 72 13 51 51
15 minutes by car
4 subway stops

Mercure Lyon Part Dieu
50 rue de la Villette, 69003 Lyon - Tel: + 33 (0) 4 72 68 25 20
15 minutes by car
4 subway stops

Novotel Confluence
3 St. Paul Montrochet, 69002 Lyon - Tel: + 33 (0) 4 37 23 64 00
30 min tram and bus