Training on APR-PQR and CAPA System

09:00 – 13:00 COURSE SESSION

• EU, US and ICH regulatory requirements, definition of responsibilities and role of APQR in Quality Management System
• How to efficiently structure data collection, timing, definition of actors involved, merging criteria and rationales
• APQR chapters: complete example of an APQR with comments on the main contents of individual chapters
• CAPA Management System: overview of cGMP requirements and EMA-FDA Guidelines
• CAPA: sources, critical steps and example of a CAPA form
• Deviations: introductory hints and relationship between CAPA and deviations

Personnel involved in the areas of Quality Assurance, Quality Control, Compliance and Operations.

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.