How to Perform Effective Product Quality Reviews
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On 1 January 2026 the EU implemented a change to Chapter 1 of the EU GMP Guide to add the requirement to produce a regular Product Quality Review. This listed numerous criteria which should form part of that review.
Tuesday 23 October 2025
Manchester Airport Marriott Hotel, Manchester, UK
£715.00 excl. VAT – £858.00 incl. VAT (first booking)
£572.00 excl. VAT – £686.00 incl. VAT (additional bookings from same site)
Type: Pharmaceutical
About this course
On 1 January 2026 the EU implemented a change to Chapter 1 of the EU GMP Guide to add the requirement to produce a regular Product Quality Review. This listed numerous criteria which should form part of that review.
The FDA has long required product reports to be submitted for licensed products and ICH Q7, GMP for Active Pharmaceutical Ingredients, also requires that “processes should be periodically evaluated to verify that they are still operating in a valid manner”.
This course is designed to assist you and your company in producing Product Quality Reviews which meet these GMP expectations in an efficient manner that will add VALUE to your business as well as compliance to your operations.
What You Will Learn
- The regulatory requirements for medicinal products and Active Pharmaceutical Ingredients in the EU and USA
- The data that should be included in a Product Quality Review and what may be excluded
- Statistical techniques to enable you to analyse and interpret data effectively
- How to decide if a process is in control, capable and still valid
- How to produce Product Quality Review reports which add value to your business and meet all regulatory expectations
Course outline
Periodic Product Reviews
- What they are and why they are important
- Current regulatory expectations:
- EU GMP Chapter 1
- US CFR 21
- ICH Q7
- Data requirements
Data Analysis Techniques
- Pareto charts
- Control charts
- Process capability
- Linear regression
Data Interpretation
- How to identify trends in, and draw conclusions from, data
Product Review Reports
- How to present the information
- How to document conclusions
Acting on the Information
- How to make the exercise add value to your business
Discussion and Working Groups
A significant proportion of the course will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods will provide delegates with an opportunity to have their specific questions answered.
Venue
Manchester Airport Marriott Hotel, Manchester, UK
The Manchester Airport Marriott Hotel is just five minutes by courtesy bus from the airport and railway station. Transport will also be available, free of charge, at the close of the course to take you from the hotel to the airport. Situated adjacent to the M56 motorway, it is also easily accessible by road.
With its comfortable bedrooms, swimming pool and fitness room, the hotel is an excellent place to relax as well as learn.
Hotel Accommodation
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Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
- To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
- This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
- If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check-out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What Previous Attendees Said About This Course
“Very useful, lots of food for thought.”
Sylvia McDonald, Pharmapac UK Ltd, UK
“The course was great and met all my objectives and will most certainly help me implement a satisfactory PQR into our quality system.”
Ian Snowball, Fujifilm Diosynth Biotechnologies UK Ltd, UK
“Good course would have been great 3 years ago to avoid lots of pain and capture opportunities.”
Scott Roach, Ipsen Biopharm Ltd, UK
“Course highlighted areas in relation to trending that will benefit our product quality review.”
Steve Couchman, Medimmune UK Ltd, UK
An NSF International Company
