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?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- Impact of variations on the site regulatory and compliance activities
- La registrazione di un farmaco: focus sulle linee guida di tossicologia e struttura CTD per la sezione preclinica
- Skilful drafting of technical documentation
- Drugs registration requirements in extra-EU countries
- Basic training in Regulatory Affairs
- Common Technical Document (CTD) module 3: focus on the most critical aspects
- Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
Key points of the training
- Efficiently and effectively address and perform task between multiple entities inside and outside the manufacturing site.
14:00 – 17:30 COURSE SESSION 1° Edition
09:00 – 12:30 COURSE SESSION 2° Edition
- 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
- 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.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. 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.
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.
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.
You may also be interested in...
- 4-5 October 2023
- 12-13 March 2024
- 12-25 October 2023
- 13 October 2023
- 14 March 2024
- 29 September 2023
- 6 March 2024
- 6 November 2023
- 16 April 2024
- 10 November 2023
- 11 March 2024
- 14-15 November 2023
- 16-17 May 2024
- 15-29 November 2023
- 8 March 2024
- 11-12 December 2023
- 23 February - 1 March 2024
- 12-13 December 2023
- 23-24 May 2024
- 14 December 2023
- 3 June 2024