Control of Contamination

The new version of ISO 14644-2:
What changes?

MC14

Date

April 26 2018

7 h face-to-face

Effective work

Formative

Philippe DUHEM

Price

800 € HT

(Déjeuner inclus)

Objectives

- Know and understand the objectives and provisions of the new version of the ISO 14 644-2.
- Know and understand the points to consider in developing a monitoring plan.
- Know and understand the elements to consider in setting monitoring limits.

Public

  • Beginner
  • Intermediate
  • Expert

- Technician
- Framework of Quality Assurance, Production, Environmental Control Services

Programs

1. Reminders of the objectives of this standard

  • 1.1. Differences in Approaches Between Classification Logic (ISO 14644-1) and Monitoring Logic (ISO 14644-2)
  • 1.2. Positioning of surveillance in a GMP-type operating context:
    • 1.2.1. Qualification
    • 1.2.2. Classification
    • 1.2.3. surveillance
    • 1.2.4. Maintenance of Qualified status


2. Reminder of the general strategy for implementing a monitoring plan

  • 2.1. General principles
  • 2.2. General strategy for implementation


3. Expected elements for the monitoring plan


4. Considerations for developing the monitoring plan

  • 4.1. The risk analysis
  • 4.2. The definition of the operational conditions to be monitored
  • 4.3. The choice of parameters to monitor and the conditions of this monitoring


5. Considerations for establishing monitoring limits

  • 5.1. Determination of normal operating ranges
  • 5.2. Determination of alert and action limits
  • 5.3. Determination of the conduct to be taken in the event of exit from the surveillance limits


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

Questionnaire de satisfaction

Program PDF version

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

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

DUHEM

Philippe DUHEM - INTERTEK

A biochemist and biologist by training, he spent 10 years in the pharmaceutical industry as production manager before joining Intertek Group where he is a senior consultant. Expert in GMP and clean and sterile processes, he is particularly active in the health industries where he provides validation, consulting, audit and training missions.
An expert on the international standardization committee in charge of ISO 14644-1 and 14644-2 standards, he also provides regular training to inspectors from certain health product regulatory authorities.

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