Impact of variations on the site regulatory and compliance activities
- 1° EDITION: 6 November 2024
- 2° EDITION: 2 April 2025
- Online
-
Italian
- 1° EDITION: 6 November 2024
- 2° EDITION: 2 April 2025
- Online
-
-
Italiano
-
Training overview
The “Impact of variations on the site regulatory and compliance activities” training course focuses on deepening the correlations between variations that occur in the manufacturing site and the registration dossier. The program is designed for the site regulatory functions and compliance functions so as to deepen some of the knowledge they must possess to efficiently and effectively address and perform their task as an interface between multiple entities inside and outside the manufacturing site.
Are you interested in Regulatory Affairs?
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:
- CTD Modulo 3: I Punti Critici
- La Scrittura Efficace dei Documenti Tecnici
- Aspetti Regolatori degli Integratori Alimentari e Novel Food
- Focus sul Modulo 5 del CTD
- Requisiti Registrativi per gli APIs in area extra EU
- La Registrazione di un Farmaco: Linee-Guida di Tossicologia e Struttura CTD per la Sezione Preclinica
- Impatto Regolatorio dei Cambi
- Affari Regolatori: Le Basi dei Regulatory Affairs
- Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China – English training
- Marketing Authorization Holder (MAH), Affari Regolatori e Qualified Person: Responsabilità ed Interazioni per la Compliance GMP
- La Gestione delle Elemental Impurities
(*) 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.
Key points of the training
- Efficiently and effectively address and perform task between multiple entities inside and outside the manufacturing site.
09:00 – 13:00 COURSE SESSION 2° Edition
API
- CEP/DMF Changes
- PhEur changes (e.g., heavy metals or general methods)
- Reference normative changes (e.g., ICH Q3D, ICH Q7)
- Experimental activities and reference legislation to support changes
- Documentation to support variations
FINISHED PRODUCTS
- Process changes (e.g., batch size change and minor changes)
- Tech transfer and possible related variations
- Correlation between API and finished product variations
- Insight into groupings, acceptable and not, that can be applied to complex gap projects
Regulatory Affairs, Quality Assurance, Qualified Person.
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.
Speakers
Raffaella Pandini
Regulatory Affairs Director at Pharma D&S
Graduated in 1997 in Pharmaceutical Chemistry and Technologies at the University of Milan, she gained professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. Pandini began her career in the regulatory affairs of Rottapharm srl and subsequently worked as RA Senior Officer at Zambon Group SPA. Since 2006 she has been Regulatory Affairs Director at PHARMA D&S and she is also involved in training activities within the Pharma Education Center.
Register now
600€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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