Technology Transfer di successo – Implicazioni e Responsabilità

Struttura del corso

09:00 – 13:30 SESSIONE CORSO

Programma

1. Rassegna delle Linee Guida

• Eudralex Vol. 4 EU GMP Part I Chapter 7 “Outsourced activities”
• ICHQ10 “Pharmaceutical Quality System” (Quality System Model)
• ICH Q9 “Quality Risk Management”
• Eudralex Vol. 4 EU GMP Annex 15 “Qualification and Validation”

2. Parole Chiave e riferimenti incrociati tra EU GMP & Modello di Sistema Qualità secondo ICH Q10

• Knowledge Management
• Change Management
• Continual Improvement

3. Riferimento al Technology Transfer in EU GMP (Eudralex Vol.4) Part I Chapter 7

• Principi e Attività Generali
• Contract Giver e Contract Acceptor: Ruoli e Responsibilità GMP

4. Attività di Technology Transfer – Requisiti generali e attività preliminari

• Contratti e accordi
• Knowledge Management condiviso tra Contract Giver e Contract Acceptor

5. Contract Giver – Ruolo e Responsabilità

6. Contract Acceptor – Ruolo e Responsabilità

7. Obiettivi comuni durante gli step del Technology Transfer

• Gap Analysis Regolatoria
• Protocollo di Technology Transfer
• Approccio all’ Analytical Transfer/Convalida Metodo
• Approccio alla Convalida di Processo
• Gestione dei Cambiamenti e di fattori interni (es. Deviazioni)
• Monitoraggio Continuo
• Metriche di Performance (KPIs) e di Qualità
• Review Periodiche dl Sistema Qualità

8. Sessione finale

• Case studies
• Q&A

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.

Attendance to the event will be allowed upon receipt of payment.

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.