Come gestire un Technology Transfer di successo

Struttura del corso

09:00 – 13:30 SESSIONE CORSO

Programma

1. 1. Overview delle line guida:
      • EU GMP Pt.I Chapter 7
      • EU GMP Annex 15 (Qualification and Validation)
      • ICH Q9 (Quality Risk Management)
      • ICHQ10 (Quality System model)
2. 1. 2. 1. EU GMP Pt.I Chapter 7 :
         • Principi
         • Attività generali
         • Contract Giver e Contract Acceptor: Ruoli e responsibilità GMP

1. 1. 1. 1. 3. Cross-references con Annex 15, ICH Q9
            4. Cross-references con gli obiettivi dell’ ICH Q10-Quality System model:
            • Knowledge management
            • Continual Improvement

1. 1. 1. 1. 5. Outsourced activities – Requisiti generali, attività preliminari

• • 1. • • Gap Analysis
         • Risk Management
         • Change Management
         • Il Protocollo del Technology transfer
  • 1. 1.  6. Contract Giver – Ruolo e Responsabilità
          • Scambio di informazioni
          • Assistenza al “Contract Acceptor” nella fasi di assessment preliminare, per quanto riguarda:
          • Quality risk assessment
          • Change control Management
          • Process performance and product quality monitoring

1. 1. 1. 1. 7. Contract Acceptor – Ruolo e Responsabilità (“Pilastri” ICH Q10)
            • Process performance and product quality monitoring
            • Applicazione di un efficace CAPA System (Corrective Actions and Preventive Actions)
            • Applicazione di un efficace Change Management System
            • Continual improvement tramite il monitoraggio dei fattori interni ed esterni

1. 1. 1. 1. 8. Obiettivi comuni durante gli step del technology transfer
            • Gap analysis regolatoria
            • Protocollo del Technology transfer
            • Approccio all’ Analytical transfer/Convalida Metodo
            • Approccio alla Process validation
            • Gestione dei change e dei fattori interni (ex: Deviazioni)
            • Continuous performance e product quality monitoring
            • Performance/Quality metrics e periodical review

1. 1. 9. Workshop – Sessione finale
      • Case studies
      • Fattori chiave per cogliere pienamente gli obiettivi del technology transfer
      • 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.

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.