Training on Good distribution Practice (GDP)
- 2° EDITION: 2 April 2025
- Online
Italian
- 1° EDITION: 21 October 2024
- 2° EDITION: 2 April 2025
- Online
-
Italiano
Training overview
This training course on Good Distribution Practice (GDP) will explain you the European and local regulatory environment for the distribution and marketing of medicinal products. The training will examine the application of the November 5 2013, Guidelines on Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01), which establish the appropriate tools to assist wholesale distributors in carrying out their activities; these activities are carried out with manufacturers or their depositories.
Key points of the training
- Regulatory framework for product distribution and marketing
- GMP and GDP: general concepts
- Focus on Good Distribution Practice (GDP) of medicinal products
- Pharmaceutical transportation and safety aspects: measures to combat pharmaceutical crime
- Drug traceability
- The responsibility of the various actors in the drug supply chain
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
- Regulatory framework and guidelines for medicinal products distribution and marketing
- GMP and GDP: general concepts
- The responsibility of the various actors in the drug supply chain
- Drug traceability
- Pharmaceutical transportation and safety aspects: measures to combat pharmaceutical crime
- Focus on Good Distribution Practice (GDP) of medicinal products:
- Quality Management
- Personnel and training
- Documentation
- Premises and Equipment and Operations: receipt and storage
- Complaints, returns, suspicions about falsified medicines, and medicine recalls
- Outsourced activities
- Self-inspections
- Broker
- Q&A time
Quality Assurance, Regulatory, Supply Chain and Logistics.
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 in**@ph*******************.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 in**@ph*******************.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.
Speakers
Elena Fracassetti
Process & Quality Senior Consultant - Team Leader presso Pharma D&S, a PLG company
Dopo aver conseguito la Laurea magistrale in Chimica presso l’Università Degli Studi di Firenze inizia la sua attività lavorativa nel 2013 come Quality Assurance shop floor in Novartis Vaccines and Diagnostics, poi GSK Vaccines presso il sito di Rosia fino ad arrivare in Pharma D&S a maggio 2016, dove oggi ricopre il ruolo di Process & Quality Senior Consultant – Team Leader.
Si occupa di sviluppo di Sistemi di Qualità e di Qualità in Farmacovigilanza in ambito farmaceutico e di supporto operativo Quality e per lo svolgimento delle attività di maintenance dei Sistemi di Qualità per Titolari AIC/affiliate di multinazionali, secondo la normativa locale applicabile, le GMP/GDP/GVP, le norme ISO 9001e le linee guida Farmindustria. Ha ricoperto inoltre il ruolo di Responsabile Qualità e Responsabile di Qualità in Farmacovigilanza per affiliate Italiane di multinazionali e di aziende titolari AIC Italiane.
INTERESTED IN QUALITY & PROCESS TRAINING?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- Qualified Person: Training and Updates
- EU Updates on IMPS – Investigational Medicinal Products
- Training on Good distribution Practice (GDP)
- Audit and Inspection in the pharmaceutical
- Technology Transfer in the pharmaceutical– English training
- Inspection Readiness Documentale
- Training on APR-PQR and CAPA System
- RCA – Analisi delle Cause Radice: aspetti strategici ed applicativi
- Quality Risk Management: Corso Base – Linea-Guida ICH Q9 (R1): Teoria, Tools ed Applicazioni nel Farmaceutico
- Quality Risk Management: Corso Avanzato – Approfondimento sui Nuovi Requisiti ICH Q9 (R1) ed Applicazioni nel Sistema Gestione QualitÃ
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Register now
850€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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