Spotlight sessions from Kite Pharma and Orchard Therapeutics at SMi’s Aseptic Processing Conference

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The Aseptic Processing Conference will be held on 20th and 21st September in London, UK, delegates have the option to attend virtually. This conference will bring together industry experts that will explore aseptic facility design and operation to implement agile contamination control strategies.

Interested parties can register at http://www.asepticprocessing.co.uk/PR3

Below are the spotlight sessions from Kite Pharma and Orchard Therapeutics on:

Day One: 20th September 2021: Scott Nichols, Quality Compliance Lead from Kite Pharma will present on FDA’s Current Expectations on Sterile Biotechnology Drug Product Manufacturing, covering:


• FDA’s regulatory framework relating to Aseptic Processing


• Discussion of common review/filing issues relating to sterility assurance


• Outcomes from GMP inspections


Day Two: 21st September 2021: Jingjing Li, Senior Manager, QA, Orchard Therapeutics will present on: Designing a quality management system (QMS) for ATMP Manufacturing, covering:


• Reviewing the elements of a QMS for ATMP manufacturing


• Integrating contamination control into the QMS


• Aligning QMS with operational models


• Managing QMS lifecycle


The conference is attended by senior microbiologists, cleanroom managers, sterility assurance specialists, senior QAÂ’s and QCÂ’s and those that are involved and interested in new regulations for compliant pharmaceutical manufacturing in aseptic processing.

The conference brochure with the agenda and expert speaker line-up is now available to download from the website: http://www.asepticprocessing.co.uk/PR3

Sponsored by: ILC Dove, Innerspace, Solo Containment and STERIS

For tailored sponsorship and branding packages contact Alia Malick, Director on +44 (0)20 7827 6168 or email amalick ( @ ) smi-online dot co dot uk

For media enquiries, contact Simi Sapal, Head of Marketing on +44 (0)20 7827 6162 or email ssapal ( @ ) smi-online dot co dot uk

SMiÂ’s Aseptic Processing Conference


London, UK


Conference: 20-21 September 2021


Workshop day: 22 September 2021


LinkedIn & Twitter: #SMiAseptic


http://www.asepticprocessing.co.uk/PR3

About SMi Group:


Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk.

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