Challenges in Sterile Products Manufacture 2019

Challenges in Sterile Products Manufacture 2019

Thursday 06 June 2019

Welcome to the Online Accommodation Registration Site for the PHSS Sterile Products Manufacture Conference 2019 taking place at The Mere Golf Resort and Spa, on Thursday 6th June 2019.

Successful Events have secured preferential rates with The Mere Golf Resort and Spa Hotel. 

Accommodation is available for the 5th, 6th and 7th June 2018.

All bookings are subject to availability and must be completed prior by Wednesday 10th April 2018 to take advantage of the special negotiated rates, however cancellations can be made without penalty before 2pm on 3rd June 2018.

Credit card details for guarantee purposes will be required.

As new pharmaceutical, biological products, advanced medicinal therapies and manufacturing technologies develop there are issues of clarity in GMP guidance required. GMP chapters and Annex guidance’s cannot be prescriptive on all issues and allow for development and innovation. In addition some flexibility is allowed to facilitate product and pharmaceutical processing experts to develop rationale, methodology, good practice with procedures and acceptance criteria to suit novel and specialised medicinal and therapeutic products. 

To support these aims GMP relies on interpretation of guiding principles that have patient safety as a focus together with application of Pharmaceutical Quality systems (PQS), Quality Risk Management (QRM) and Quality by Design (QbD) that reinforce a risk based approach in sterile product manufacturing and associated non-sterile components/ APIs. EU GMP Annex 1 revision will clarify some current issues requiring clarity in GMP but still there will be a need to apply principles where prescriptive test or best practice guidance remains open to application and interpretation.  

This PHSS GMP ‘clarity of issues’ conference brings together, key opinion leaders, subject matter experts together with Ex and current GMP regulatory inspectors to debate and provide clarity on areas and topics of GMP where interpretation is challenging and shared experience within the neutral platform of the PHSS conference provides an opportunity to understand approaches and expectations to GMP compliance.

Meeting Venue

The Mere Golf Resort and Spa

Mere, Knutsford, WA16 6LJ

Successful Events

Successful Events are the official accommodation partners and liaison team for the PHSS Sterile Products Manufacture Conference 2019 and we are here to help take care of your booking requirements during your visit to The Mere Golf Resort and Spa.

Using the official service means you get some great additional benefits: 

  • Best rates guaranteed at the hotels closest to the event venue
  • Live online booking service
  • Friendly team of specialists
  • Rooms secured exclusively for you for when you are ready to book
  • Plan your entire visit conveniently with us; hotels, restaurants, airport transfers and more

For enquiries relating to your accommodation booking on this website, please contact:

E: james@successful-events.co.uk
T: +44 (0) 113 2034522
Office Hours -  Monday – Friday, 9.00am – 5.30pm, closed on weekends and Bank Holidays.

PHSS
For enquiries relating to The PHSS Sterile Products Manufacture Conference 2018 please contact:

Tamsin Marshall
E: info@phass.co.uk
T:+44 (0) 1793 824254

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