Good Manufacturing Practices
Process of accreditation and monitoring of excipients manufacturers
BPF06

Date

April 12 2018

7 h face-to-face

Effective work

Formative

Olivier JEAN

15,8
/ 20

Price

800 € HT

(Déjeuner inclus)

Objectives

- Know the main expectations and requirements of the 19 March 2015 European directive.
- Know and apply useful analysis tools to define the risk profile of your excipients.
- Think about the appropriate GMP according to the risk profile of your excipients.
- Know how to determine the risk profile of your manufacturers.
- Know how to monitor the quality of its excipient manufacturers and confirm the application of GMP.

Public

  • Beginner
  • Intermediate
  • Expert

Anyone involved in the accreditation process and quality monitoring of the manufacturers of excipients
Anyone of quality and purchasing services

This internship is for the pharmaceutical companies holding the MA, as well as the manufacturers of excipients.

.

Programs

This training will present the main expectations and requirements of the 19 March 2015 European directive and will make it possible to apply the analysis tools that are useful for defining the risk profile of excipients.
It will also make it possible to determine the risk profile of the manufacturers of these excipients and to adapt the quality monitoring of these suppliers.

MORNING
Part I: Presentation of the Directive and Analysis Tools

  • Presentation of the directive
  • Exposed
  • Discussions and exchanges


Presentation of tools and methods to answer them

  • Definition of the risk profile of excipients (multi-criteria analysis)
  • Definition of GMPs required (table)
  • Definition of the manufacturer's risk profile (multi-criteria analysis)
  • Crossing of two risk profiles (approval process)
  • Quality monitoring of the manufacturer of excipients (demerit)
  • Expression of expectations (CdC and quality questionnaire)


Balance sheet

  • Self evaluation
  • Reflection on the strengths and progress of your company
  • Writing an action plan

AFTERNOON
Part Two: Practical Applications

Work in teams

  • Constitution of teams and distribution of exercises:
    - Definition of profiles
    - Definition of GMP
    - Definition of needs
    - Quality report
  • Reflection in subgroups: exercises
  • Collective return (subgroup)
  • Summary & drafting of an action plan


Working matrix presentation

Expression of GMP requirements

Saving GAP

Évaluation des connaissances acquises et évaluation des actions d’améliorations entreprises et/ou envisagées

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

JEANS

Olivier JEAN - INTERTEK

After a first experience in the industry, he joined the team Intertek where he participated in the development of training, audit and quality advice.
Today, after years of experience 20 from health industries, he manages a few years the commercial, marketing and development of training activities, audit, consulting and validation of the healthcare division of Intertek France.
He is also a trainer and consultant listener and works in the area of ​​continuous improvement, quality risk management and accreditation of providers.

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 / Practical exercises / Work in subgroups.

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