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white stopmicrobe Validation of the production equipment's cleaning processes in pharmaceutical industry

MC02      
PUBLIC
- Setting and technician in charge of cleaning validations
- Quality Manager
OBJECTIFS
• Develop and improve their knowledge of the regulatory and technical requirements in order to optimize its own validation strategy in accordance with the GMP US and Eu.

MOYENS PEDAGOGIQUES
En début de session, grâce à un questionnaire, le formateur analyse le niveau de connaissances des professionnels sur le sujet ainsi que leurs attentes des connaissances à acquérir.
Le formateur adapte le programme de la formation en fonction du profil des différents participants. Un temps est consacré aux échanges d’expériences entre participants et avec le formateur.
After the course, participants will receive paper and digital copies of the course's content.

 

PROGRAMME   NOTE MOYENNE
3312812908given by previous interns

DUREE
2 days


DATE
4 and 5 2017 April


FORMATEUR
Pierre Devaux
Head Pharmacist
Expert in contamination control


TARIF
1 200 € HT
(Lunch included)


PICTO telechargerPDF 01


inscriptionmc

Validation

• Definition of validation of cleaning processes
• General Methodology
• Analysis of US and European standards: Explanations of the new Annex 15 GMP on the subject, applicable since October 2015
• What cleaning processes must be validated?
• Importance of prior definition of a strategy and organization of the Steering Committee
• What contaminants and tracers should you look?
• The calculation of acceptance limits according to CRP approach with callback methods for calculating the "old" criteria
• The different methods of sampling, samples expected yields
• Rational sampling plans
• Analytical methods coupled to removal, key points of the method validation



• Building its strategy for efficient validation with maximum return on investment (optimization methods, groupage, "worst case", special products, etc.): presentation types matrices

• The documentary elements (validation master plan, protocols, reports, etc.)
• What follow and when revalidate? Maintaining the validated state
• Conclusions

Qualifications ways
• The prerequisites for validation
• Qualification of human, physical and chemical differences between automated and manual cleaning

Summary and Discussion

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

Questionnaire de satisfaction

   
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
Pierre Devaux
pierredevauxExpert Control of Contamination
An expert in contamination control, he performs audit, consulting and training missions for the Healthcare Industries around UPS Consultants around the following themes: validation of cleaning, cleaning of premises, good Aseptic practices, implementation Place of risk analysis to control the contamination of manufacturing processes, GMPs audits and investigation on problems of contamination of products.

Training A3P:
MC02 - Validation of production equipment cleaning processes in pharmaceutical industry
MC07 - Development of a bio-cleaning program in cleanrooms in GMP environment
MC08 - Control of contamination by ZAC (sterile and non-sterile)

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