Training on APR-PQR and CAPA System

  • 2° EDITION: June 4th 2024
  • Online
  • Italian

Training overview

The training course “APR, PQR and CAPA System” is structured in two parts: the first will explain the current regulatory requirements (EU – FDA) for the issuance of PQR and APR reports with a detailed description of the contents of the individual chapters, as well as the organizational flow, timing, definition of the actors involved and the collection of supporting data to ensure effective and timely issuance of the document, in compliance with regulatory requirements.

The explanation will be followed by a complete example of PQR, with comments on the main contents of the individual chapters and insights directed at highlighting tools for “Continuous Improvement.”

In the second part of the course, on the other hand, the CAPA Management System and the management of Deviations as an integral part of Quality System Management will be explained.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • November 20th 2024
  • May 14th 2025

(*) Contact us via email or phone to enroll.

Key points of the training

  • Understand the importance of APR/PQR reports
  • Know the regulatory requirements for the Europe and U.S. markets
  • Efficiently structure data collection, timing, definition of actors involved, merging criteria and rationales
  • Have detailed knowledge of the contents of an APR/PQR
  • Know the CAPA and Deviations management 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 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 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.


Filippa Lo Biundo

Filippa Lo Biundo

Process & Quality - Team Leader Senior Consultant at Pharma D&S

She graduated in Pharmaceutical Chemistry and Technology at the University of Pisa in 2015. She began her career in pharmaceutical consultancy covering the role of Compliance and Maintenance Consultant, until arriving at Pharma D&S where she has been working as Quality for about two years and Process Consultant. Over the years she has carried out various activities: support to companies in preparing for GMP and medical device inspections in accordance with MDR 2017/745 (gap analysis), development of Quality Risk Management methodologies and drafting of risk assessments, execution of Training on Systems of Quality GMP and support in the drafting of GMP documentation, in particular SOP, APR and PQR and evaluation of PQR drafted by third parties.

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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