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Challenges in Sterile Product Manufacture 2019
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Challenges in Sterile Product Manufacture 2019

06/06/2019
When: 6th June 2019
9:00 AM
Where: The Mere Golf and Spa
Chester Rd
Mere
Knutsford WA16 6LJ
United Kingdom
Contact: Tamsin Marshall
+44 (0)1793 824254


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Challenges in Sterile Product Manufacturing with GMP Compliance


Thursday 6 June 2019

 

PHSS are pleased to announce our Gold Sponsor 

The annual PHSS challenges in sterile product manufacturing comes at a time when the Pharma industry is under challenge with new GMP regulations (revision of Annex 1), new product types require processing with new technologies that require application of Quality Risk Management to meet GMP compliance and requirements of patient safety.


This conference provides a perspective from regulators 
(MHRA), Global GMP auditors, advanced therapy manufacturers, technology manufacturers and academics on current challenges.
NOT A CONFERENCE TO MISS.

 

Agenda to download

Regulatory and GMP Audit sessions 
MHRA keynote presentation; Phil Rose MHRA GDMP expert Inspector:
Current GMP inspection findings and regulatory expectations in sterile product manufacturing.
Andrew Hopkins Abbvie Director Operation Quality, QA Audit and compliance.

Current findings and challenges in QA Audits, GMP compliance expectations and lessons learned. 

Product manufacturing/ Aseptic processing sessions
• Oxford BioMedica OXBOX case study. Melanie Bull Process lead & Adam Bird Site QA Manager.

Case study: Development of a combined formulation and vial filing platform for Aseptic process filing of a viral vector used in advanced cancer
therapy
Dr Holger Kranenburg Aseptic containment lead at F Ziel GmbH and PHSS Aseptic containment special interest focus group.Development of Aseptic 
Containment strategies and containment solutions in Aseptic process filing. 
David Martin Project Sterility Assurance Manager GSK Barnard Castle.

 Case Study: A Pharma Industry perspective on what is required to fill quality sterile products for the next 20 years. 

New research sessions
Laurent Leblanc Biomerieux Healthcare business, Pharmaceutial and culture R&D Manager.

 New research: Challenges in viable colony counting by visual inspection of growth media as part of environmental monitoring programs. 
Professor C William Keevil University of Southampton. Professor of Environmental Healthcare,natural and environmental sciences

 New research on Viable but Non culturable bio-contamination (VBNC) and relevance to sterile product manufacturing.

Practical demonstration
• Video and discussion of Aseptic transfer ports that do not require an operator intervention into an Isolator/ RABS Barrier system.
• Gloveless aseptic transfer systems for single use systems and pre-sterilised components including stoppers to support new Gloveless operation filing platforms.


The annual PHSS challenges in sterile product manufacturing conference comes at a tie when the Pharma industry is under challenge with new GMP regulations (revision of Annex 1).
New product types require processing with new technologies that require application of Quality Risk Management to meet GMP compliance and requirements of patient safety.
This conference provides a perspective from regulators (MHRA), Global GMP auditors, advanced therapy manufacturers, technology manufacturers and academics on current challenges.
NOT A CONFERENCE TO MISS.


 

Please click here for download. 

 

Accommodation link (click here) for booking at reduced rates. Bedrooms will shortly be released. 

 

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