Effective management of Annual Product Review (APR), Product Quality Review (PQR) and Corrective Actions-Preventive Actions (CAPA)

  • 2° EDITION: 4 June 2024
  • Online
  • English

Training overview

The training course “Effective management of Annual Product Review (APR), Process Quality Review (PQR) and Corrective Actions-Preventive Actions” is addressed to pharmaceutical professionals dealing with Quality Assurance that wish to deepen their knowledge on these pivotal documents. The training is structured in two parts. In the first part, the current regulatory requirements (EMA, FDA) for issuing APRs and PQRs are explained in detail for each single chapter. The organizational flow, timing, definition of the actors involved and the collection of supporting data to ensure the effective and timely issuance of the document, in compliance with regulatory requirements, will be examined. This theoretical explanation will be then followed by a practical example of a PQR, with detailed comments, helpful for the attendee, as well as hints aimed at pursuing “Continuous Improvement”. In the second part of the course, the CAPA Management System and the management of Deviations, as integral part of the Quality Management System, will be thoroughly illustrated. Attendees will be actively involved during the discussion, so to address questions and doubts and help them gain the right tools to apply in their daily job routine.

Key points of the training

  • Understand the role, importance, and learn in depth the contents of APR/PQR reports
  • Be informed on the EU and US latest regulatory requirements for these documents
  • Spot the actors involved and define a timely data collection
  • Learn all about CAPA and deviations management system
  • Know the CAPA and Deviations management system

Times are UTC +1 (Rome time)
Training session: 9:00 am – 1:00 pm

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

This training is mainly addressed, but not limited to, professionals belonging to 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.

Speakers

Filippa Lo Biundo

Filippa Lo Biundo

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

Graduated in Pharmaceutical Chemistry and Technology at the University of Pisa (Italy), she has started her activity in pharmaceutical consultancy covering the role of Compliance and Maintenance Consultant, she now covers the role of Quality and Process Consultant. Over the years she has carried out several activities: supporting companies in the preparation for GMP and medical device inspections according to MDR 2017/745 (gap analysis), development of Quality Risk Management and drafting risk assessments, performing trainings on GMP Quality Systems and supporting the drafting of GMP documentation, in particular SOP, APRs and PQR and evaluation of PQR drafted by third parties.

Register now

Early Bird 10%
Within 2 months before the start of the training
495€
550€
Early Bird 5%
Within 1 month before the start of the training
520€
550€
Full price

550€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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