Impact of variations on the site regulatory and compliance activities

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 in**@*******************er.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**@*******************er.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.