Product Quality Reviews (PQRs) are used to:

  • verify the consistency of the current manufacturing process
  • verify the appropriateness of current specifications (starting materials and finished product)
  • identify trends and opportunities for improvement

PQRs are important in process and product control, providing useful information for the quality unit and in particular the Authorised Persons responsible for Release For Supply. As such, GMP inspectors from the TGA, Medsafe and other regulatory bodies will review the Product Quality Review process and documents as part of a GMP inspection.

statistical-control-chart

Your PQRs contain a lot of data, but are you applying appropriate critical analysis and interpretation of the findings to deliver value to your company and ensure GMP compliance?

Without appropriate analysis and interpretation, Product Quality Reviews can be a financial burden on your organisation or, worse still, mask a potential product quality problem.

Content

Our training can help by providing you with the guidelines, tools and procedures to conduct effective Product Quality Reviews which will support GMP compliance and improve the quality of the decision making in your organisation. This course will help you determine the adequacy of the manufacturing controls and product specifications you have in place.  The training will address:

  • PQR procedures, documentation and records
  • How to review production records and stability studies
  • Identifying trends and potential problems
  • How to summarise the results of the product review
  • Use of statistical tools including Cp and CpK, Statistical Process Control (SPC)
  • How to address microbiological compliance
  • The PQR report
  • How to prepare a presentation to key management personnel
  • Application of risk management to the PQR process
  • Requirements for listed complementary medicines
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 is delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.

A digital credential (badge) will be issued via Credly on e-mail to recognise successful training completion.

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 half-day sessions:

 Sessions  Dates  Times
 Day 1  21st June 2022  9:00am-12:30pm
 Day 2  22nd June 2022  9:00am-12:30pm

Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00

Fee and Discount
  • AUD $650 (excluding GST) per participant; introductory offer
    • A 10% discount applies for 3 or more participants from the same company

New Session Dates To Be Advised

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

Refer to the Terms and Conditions

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Proposed Trainer

Gloria Pang

Gloria has over 26 years of experience in the GMP-regulated pharmaceutical and medical device industry. Gloria has managed various quality systems elements of organisations and was responsible for sustaining them to the required standards, including PIC/S, USFDA, EU, ISO, and ICH. Her principles areas of expertise include Quality Systems, Laboratory Control, Product Conformance Initiatives, Quality Assurance and GMP Upgrade Strategies, and validation. In addition, she has conducted numerous 3rd-party audits and gap analysis and provided remediation strategies in facilities intended for the manufacturing of APIs, final dosage forms, and medical devices. Besides establishing compliance, she has developed ISO/GMP/GDP training programs and delivered courses for organisations across the Asia Pacific region. Gloria can communicate in Mandarin.