SMi Group is excited to share 5 spotlight session being covered at this year’s West Coast Pharmaceutical Microbiology by Roche, Genentech, Xellia Pharmaceuticals, Bristol-Myers Squibb and Celgene Corporation, sessions will cover contamination control & microbial identification, Endotoxin testing & LER and Contamination Control considerations for special drug products:
- Opening Address on Day One: Strategic approaches to contamination control
Regulatory expectations for a contamination control strategy
Types and potential sources of microbial contamination
Best practices in management of microbial contamination, to include best practices in materials management, personnel training and gowning as well as equipment, process, and facility design
Lucia Clontz, Quality Director, Xellia Pharmaceuticals
- Low Endotoxin Recovery (LER)
What is Low Endotoxin Recovery (LER)?
PDA Technical Report No. 81 Low Endotoxin Recovery
LER impact on product quality
Quality control strategies for LER
Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech
- Just in time release of CAR-T Cell therapies
A patient centric approach for release of CAR-T Cell therapies
Overview of rapid sterility testing of CAR-T therapies
Overcoming challenges and scope for the future
3 key lessons learned from a case study
Irving Ford, Head of CAR T QC Laboratories, Celgene Corporation
- New endotoxin testing methods – A mass spectrometry based approach
Mass spectrometry-based testing methods
Impact of new testing methods on routine practices
Case study of implementation
Farnaz Nowroozi, Scientist and Manager, Genentech, Inc
- Implementation of RMM into an effective EM programme
Overview of RMM uses in effective EM programmes
Overcoming issues of implementation
Ensuring compliance
Take away points from a recent case study
Chris Knutsen, Associate Director, Microbiology, Bristol-Myers Squibb PRI
This confex is ideal for those who are interested and work as Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeial Scientist, Analytical Standards Specialist.
If you are interested in attending you can visit the website http://www.pharma-microbiology-usa.com/PJPR2, there is also an early bird saving of US$ 200 which expires on March 29th.
THE EVENT IS SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, Charles River, DuPont, FujiFilm & Microbiologics
If you are interested in sponsoring, exhibiting or speaking at this event, please contact Alia Malick, Director, on +44 (0) 20 827 6168 or email amalick@smi-online.co.uk
For media enquiries, contact Simi Sapal on +44 (0) 20 7827 6000 or ssapal@smi-online.co.uk
Pharmaceutical Microbiology West Coast
June, 5 – 6 June 2019
Hyatt Regency Mission Bay Hotel, CA, USA
http://www.pharma-microbiology-usa.com/PJPR2
#SMiPharmaMicroUSA
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