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PHSS Annual Conference 2019 in association with UCL Q3P
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PHSS Annual Conference 2019 in association with UCL Q3P

Challenges in Biological & Advanced Medicinal Therapeutic product( ATMP) manufacturing following GMP

 Export to Your Calendar 10/09/2019 to 11/09/2019
When: Tuesday, September 10, 2019
9:00 AM
Where: Map this event »
Hilton Kensington, London
179-199 Holland Park Avenue
London W11 4UL
United Kingdom
Contact: Tamsin Marshall
01793824254


Online registration is available until: 28/08/2019
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Challenges in Biological and Advanced Medicinal Therapeutic product ATMP manufacturing with GMP compliance


This major PHSS conference, in association with UCL Q3P will address the key challenges in manufacturing and aseptic processing of Biological and Advanced Medicinal Therapeutic products (ATMPs) considering challenges in GMP compliance and application of Quality Risk management
and new regulatory requirements including revision of EU GMP Annex 1

 

Regulatory and GMP compliance sessions


MHRA Speaker (TBC); Challenges in GMP compliance for processing biologicals and ATMP products. Perspective on Annex 1 revision.

Key points on compliance with Annex 1 revision including application of QRM and preparation of a Contamination Control Strategy (CCS). GMP auditor (TBC).

Overview of PHSS Clarity on GMP Guidance notes (14) published in response to MHRA Blogs, Annex 1 revision. James Drinkwater Chairman of PHSS and
leader of Aseptic processing & Bio-contamination special interest group.

 

Biological product and ATMP Processing sessions

 

Preparation of an Aseptic-Containment Strategy (ACS) to compliment the Contamination control strategy (CCS) for sterile product processing where
hazardous, potent products processing with a balance between Operator and Patient safety. Presented by PHSS Containment special interest group member.
Biocompatibility of Vaporised hydrogen peroxide bio-decontamination cycle residuals with biological products: Impact studies and analytical methods (Bio-Pharmaceutical industry speaker).

 

Environmental monitoring sessions
Design of an EM program for environmental monitoring during aseptic processing of potent and hazardous biological products including considerations on cross contamination control.

 

Free to members!

 

More details to follow! 

 

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