La Convalida dei Metodi Microbiologici

Struttura del corso

09:00 – 13:00 SESSIONE CORSO MATTINA
14:00 – 18:00 SESSIONE CORSO POMERIGGIO

Programma

SESSIONE A: RIFERIMENTI NORMATIVI PER LA CONVALIDA DEI METODI MICROBIOLOGICI

• Riferimenti normativi generali sulla convalida dei metodi
• Riferimenti normativi specifici dei metodi microbiologici compendiali

SESSIONE B: CONVALIDA DEI TESTS MICROBIOLOGICI COMPENDIAL (EU)

• Microbiological examination of non-sterile products: microbial enumeration tests and tests for specified microorganisms
• Sterility Test
• Endotoxin Test
• Antimicrobial effectiveness testing
• Microbial characterization, identification, and strain typing
• Disinfectant challenge testing

SESSIONE C: APPROCCIO ALLA CONVALIDA E GESTIONE DELLA DOCUMENTAZIONE

• Preparazione della convalida
• Esecuzione della convalida
• Elaborazione, revisione ed interpretazione dei risultati di convalida
• Gestione delle non conformità
• Come scrivere un report di convalida
• Quando e come revisionare un metodo convalidato
• Verifica periodica della suitability
• Frequenti non conformità rilevate durante le Ispezioni dalle Agenzie Regolatorie

SESSIONE D: ESEMPI DI CONVALIDA DI METODI NON COMPENDIAL

• Monitoraggi ambientali
• Monitoraggio area, superfici e personale
• Definizione e qualifica Holding Time
• Qualifica Disinfettanti secondo normative EN

SESSIONE E: DISCUSSIONE FINALE E CONCLUSIONI

Analisti/Supervisori/Responsabili CQ, Officer/Specialist/Responsabili QA e Compliance, Qualified Person, Addetti e Responsabili Validation.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.