Course Code: CPD/O/03/2021

CPD Hours: 14

The Annual Product Quality Review (APQR) is a key GMP requirement, providing assurance that manufacturing processes remain in control, specifications are appropriate, and products continue to meet quality, safety, and efficacy expectations. However, regulatory inspections frequently identify weaknesses such as incomplete reviews, poor data integrity, inadequate trending, unclear responsibilities, and ineffective use of statistics.

This training provides a practical, end-to-end understanding of APQR expectations aligned with PIC/S, FDA, and international best practices. Using real inspection examples, participants will learn how to plan, analyse, document, and defend an APQR that meets regulatory expectations and supports effective quality oversight.

statistical-control-chart

Content

Day 1 – APQR Foundations & Requirements

  • Regulatory expectations and common inspection findings
  • Scope definition, product grouping, scheduling, and responsibilities
  • Data inputs, data integrity, and source mapping
  • Qualitative review of deviations, CAPA, complaints, and change control
  • Stability trends, supplier/API traceability, and equipment/utility oversight

Day 2 – Analysis, Trending & Reporting

  • Trending of CQAs and CPPs
  • Statistical basics: SPC, control charts, and capability indices
  • Identifying drift, revalidation triggers, and systemic issues
  • Grouping strategies, review-by-exception, and regulatory considerations
  • APQR report structure, clear conclusions, and CAPA recommendations
Participants

This course has been designed for all those who are involved in gathering, analysing, or interpreting Product Quality Review data. It will be beneficial to those new to the PQR process, as well as more experienced professionals and Authorised Persons.

Format and Course Length

The course will be delivered as an online virtual-classroom training session.

Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.

The training will be delivered as 2 full day sessions with breaks.

PDF Certificates will be provided to participants electronically.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.

Sessions

Participants will attend both full-day sessions.

 Sessions  Dates  Times
 Day 1  30 November 2026  9:00am-5:00pm
 Day 2  1 December 2026  9:00am-5:00pm

Seats are limited: Only 25 participants per class

Fee
  • HKD $4320 per participant
Course Registration and Payment

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Contact us to discuss your interest in a public or private delivery of this course.

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