Good Manufacturing Practices

Aseptic processes - Performance Qualification:
Simulation / Media Fill Test (APS / MFT)

BPF12

Date

4 and 5 2018 April

14 h face-to-face

Effective work

Formative

Dominique SIERAKOWSKI

Price

1200 € HT

(Lunch included)

Objectives

From sterilizing filtration to final product: how to establish a robust, effective qualification program that meets international regulatory requirements.

Public

  • Beginner
  • Intermediate
  • Expert

Pharmaceutical industry and related industries
- Technician and manager in charge of aseptic operations
- Operator
- Quality assurance

Programs

The first day dedicated to the simulation of aseptic processes shows the importance of this regulatory requirement both in the final aseptic production phases and in the preparation of sterile active substances. Good practices and frequently encountered errors, special cases of barrier technologies are studied.
The second day on sterile filtration deals with regulatory aspects, validation of microbial retention and integrity testing.

Introduction and prerequisites

  • Update on EU, FDA, CFDA, WHO, etc. standards. the guidelines their interpretation
    and current practices in the industry.
  • Demonstrate the value of risk analysis in defining the key elements to a program of
    simulation of aseptic processes (initial and periodic).

Practical example of a risk analysis to identify the "worst case" situations and critical points of the operations to be qualified.


Case studies :

  • In conventional environment / RABS and isolators
  • For liquid and freeze-dried preparations
  • The points of vigilance for each application


The documentation :

  • How to prepare for the presentation of the MFT during an inspection
  • Integrity tests: process vessels, filling sets and sterilizing filtration.

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

Sierakowski

Dominique SIERAKOWSKI - DS COMPLIANCE

Diplômé de l’Université de Biologie, il travaille depuis plus de 37 ans dans la production de produits injectables stériles (domaine des biotechnologies) où il a occupé différents postes comme responsable de production, responsable assurance qualité et chef de projets senior; missions durant lesquelles il a développé différentes expertises dans les domaines des procédés aseptiques, de la lyophilisation et de la qualité ainsi que la mise en oeuvre et la validation de procédés de nettoyage, stérilisation, remplissage aseptique et lyophilisation dans un environnement réglementaire américain, européen et Organisation Mondiale de la Santé.

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.

Case studies and practical exercises.

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