Pharmaceutical Quality Systems: Best Industry Practice
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How good is your Pharmaceutical Quality System?
Tuesday 13 to Wednesday 14 November 2025
Manchester Marriott Victoria and Albert Hotel, Manchester, UK
£1360.00 excl. VAT – £1632.00 incl. VAT (first booking)
£1088.00 excl. VAT – £1306.00 incl. VAT (additional bookings from same site)
Type: Pharmaceutical
About this course
How good is your Pharmaceutical Quality System? 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?
Operating a PQS that is fit for purpose is difficult. Do too much and your system becomes over complex and unaffordable. Do too little and you face regulatory censure that may destroy your business. 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 seminar will help you to strike the right balance between compliance and effectiveness, without which you will not survive.
Would you like answers to the following?
- How do I successfully implement ICH Q10?
- What do the regulators expect?
- What does a simple and efficient PQS look like?
- How can I get our PQS to do more with less?
- How do I simplify our PQS?
- How do I improve what I’ve got!?
- How can I ensure our PQS drives continuous improvement?
Course outline
Industry ‘Best Practices’ for:
- 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
- Good Supply Chain Management: How to maintain quality oversight and control
- Audit 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
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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:
Dr David Watson – NSF-DBA, UK
David was formerly Vice President of Industrial Operations at Sanofi Pasteur. He has extensive knowledge of what makes or breaks global quality management systems and the role of senior management. He has lived and worked in France, Singapore, India and the USA. His passion for operational excellence in everything is unparalled!
What you've said
What Previous Attendees Said About Our External Courses
“Highly knowledgeable and friendly tutors. Will definitely attend another DBA course”
Dan Winfield, Moorfields Pharmaceuticals, UK
“Instructors are industry experienced and contain enormous practical knowledge”
Ms Ella Hwang, Novartis Vaccines & Diagnostics, US
“Excellent course, materials and tutors. Surpassed my expectations. Thanks!”
Barry Cook, Sanofi-Aventis Pharma
An NSF International Company
