Good Manufacturing Practices

REGULATORY UPDATE AND STATE OF THE ART
FOR THE MANUFACTURE OF STERILE PHARMACEUTICAL PRODUCTS

BPF04

Date

provided in 2018

7 h face-to-face

Effective work

Formative

Patrick Turlier

Price

800 € HT

(Déjeuner inclus)

Objectives

- Update on (latest) regulatory texts and "state of the art" document for the production of sterile pharmaceutical products.
- Comment on the expected interpretations.

Public

  • Beginner
  • Intermediate
  • Expert

Technician and executive of the pharmaceutical, biotechnology and associated industries involved in the manufacture of clean and sterile products for human, veterinary or experimental use

Programs

The regulatory texts Europe (GMP, Pharm Eur.) And US (Guidelines, USP) as well as those forming part of the state of the art applicable to the manufacture of sterile pharmaceutical products will be studied. Points that are subject to interpretation or that require further explanation will be discussed.
The new Annex 1 (subject to publication) will be discussed along with the approaches to regulatory inspections of sterile products.

Applicable statutory or reference documents

  • EMA - Guideline on manufacture of the finished dosage form (2017)
  • Nov 1994 US Guidance for Industry for the submission of documentation for sterilization process validation for human and veterinary drug products
  • US Guidance for the industry sterile drug products produced by aseptic processing cGMP Sept 2004
  • US Guidance for industry container and closure system integrity testing - 2008 Fev XNUMX
  • EU BPF including Annexes 1 and 17
  • European Pharmacopoeia and USP

Practical aspects

  • Air class (integrity test, speed, laminarity)
  • particulate monitoring
  • microbiological monitoring
  • Biocharge - Sterilizing filtration
  • Simulation of aseptic processes
  • Finished products and controls
  • conclusions
  • Inspection Returns / Injunctions / Recalls

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

TURLIER

Patrick Turlier

With more than 35 years of experience in the pharmaceutical industry, he has worked in various fields including development, pharmaceutical outsourcing, coordination between R & D and production, direct negotiations with regulatory authorities (Europe, USA, Canada ), the preparation and follow-up of numerous FDA inspections (site chemistry and injectables).
Responsible for quality assurance, then technical and regulatory development in an international group, he then became pharmacist responsible for production sites (including sterile products) for more than 11 years, including the preparation and monitoring of regulatory inspections France and international.

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