Pharmaceutical Quality Systems: Best Industry Practice
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How good is your Pharmaceutical Quality System?
Dates:
Tuesday 12 to Wednesday 13 November 2025
Venue:
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
Cost:
£1400.00 excl VAT - £1680.00 incl VAT
Type: Pharmaceutical
About this course
Will it comply with the requirements of ICH Q10? Will it satisfy the ever increasing demands of global regulatory agencies? With increasing levels of Warning Letters and the like is your PQS at risk? How does your PQS compare with the best in class?
Over the last 25 years NSF-DBA has audited many thousands of quality systems, some bad, many good. We have also looked at how those in the aviation, micro-electronics and automobile industries manage quality. From this research we have identified industry best practices for quality management systems. By sharing these, this course will help you to strike the right balance between compliance and effectiveness, and achieve operational excellence.
Would you like answers to the following?
- How can we achieve operational excellence?
- How do we successfully implement ICH Q10?
- What do the regulators expect?
- What does a simple and efficient PQS look like?
- How can we get our PQS to do more with less?
- How do we simplify our PQS?
- How do we improve what we’ve got!?
- How can we ensure our PQS drives continuous improvement?
Who Should Attend
Anyone interested in having a pharmaceutical quality system that is compliant and cost effective!
Course outline
How to achieve operational excellence in the following areas:
- Global Quality Management Systems: Organisation and structure
- Change Management: How to approve changes in hours
- Risk Management: The intelligent proactive approach…and risk registers!
- Documentation Systems: How to simplify and improve compliance
- Deviation Management: How to prevent ‘repeats’ and drive continuous improvement
- Human Error: How to reduce the frequency and magnitude of errors and mistakes
- Validation: How to reduce validation costs and improve process efficiency
- Training and Education: How to improve performance
- Out of Specification Systems and Investigations: Getting it right!
- Quality by Design Implementation: Translating theory into practice
- Lean and 6 Sigma Initiatives: Getting the return on your investment
- Audits and Self-Inspections: To drive continuous improvement and improve compliance
In summary, we will examine each key area of your PQS, share best practice, identify your ‘gaps’ and help you close them.
Venue
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks of the River Irwell, near the city centre but convenient for Manchester Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and a few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- 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 are provided under the ‘Hotel Bookings’ section at the bottom of this page.
- 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.
Venue Address and Contact Details
Manchester Marriott Victoria & Albert Hotel
Water Street
Manchester
M3 4JQ
England
Tel: +44 (0) 161 832 1188
Fax: +44 (0) 161 834 2484
www.marriott.co.uk
Hotel Bookings
If you would like to benefit from our specially negotiated Bed and Breakfast rate with the hotel, please book your accommodation following this link
This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
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.
What you've said
“Good course. All important aspects are covered in very limited time, but with a depth that was very good.”
Willeke van Tilburg-Kosman, MSD Animal Health Innovation, Norway
“Excellent course, recommended all QA site leaders should attend to drive change. Could have discussed for a week, but cannot be out of office for that long. Looking forward to taking back some new ideas – educators.”
Rebecca Howells, BTG International, UK
An NSF International Company 
