London, United Kingdom, March 17, 2017 --(PR.com
)-- The two day conference will discuss: Environmental monitoring, endotoxin recovery, sterility assurance, data integrity, biofilms and the hot topic of rapid microbial methods.
Rapid microbial methods will be explored on day two of the conference by Takeda, Janssen and Vericel Corporation as they look at the challenges involved, validity and US approval.
Kevin Luongo, QC Sr. Scientist (Microbiology) from Takeda will present on ‘Challenges involved with microbial control’. He will speak on: A CMO-focused microbial control strategy, the challenges with managing an external manufacturing program and the future of microbial control.
Ron Smith, Director, External Supply Integration Quality from Janssen will be providing attendees with his presentation on ‘Validation of a rapid microbial method: case studies for microbial limits and sterility testing’. Ron will provide an overview of the approach for testing equivalence of a qualitative method and case studies on demonstrating equivalence to pour plate method for Microbial Limits testing of betamethosone suspension and demonstrating equivalence to membrane filtration sterility test method for a saline product.
John Duguid, Senior Director, Research & Development from Vericel Corporation will discuss ‘US approval of three rapid microbiological methods for MACI product release’. He will speak about:
• Same day product release is needed for MACI® autologous cultured chondrocytes on porcine collagen membrane)
• Automated rapid microbiological methods enable test results within hours
• Regulatory requirements are continuing to evolve
They will be joined by GSK, Bimeda, Sanofi, Amgen, Microrite, Excellent Pharma Consulting, Renaissance Pharmaceuticals, Roche, Merck and many more…
Running alongside the conference will be two pre-conference workshops held on the 7th June.
Workshop A: Technologies for Monitoring Contamination Control and Case Studies on Contamination Control. Hosted by Jim Polarine Jr, Senior Technical Service Manager, STERIS Corporation and Andrew Bartko, Research Leader, Battelle Memorial Institute.
Workshop B: Microbial Required Use for Terminal Sterilization. Hosted by Jerry Dalfors, Principal, JD Technologies
For those wanting to attend, there is currently an early bird offer available; book by 31st March to save $200 off the conference price. Register at www.pharma-microbiology-usa.com/prcom
Pharmaceutical Microbiology USA is sponsored by Charles River, Rapid Microbiosytems and Biomerieux
For sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail firstname.lastname@example.org.
For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or email
For media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or email@example.com
Pharmaceutical Microbiology USA
8 - 9 June 2017
San Diego, California, USA
Contact e-mail: firstname.lastname@example.org
Contact tel: +44 (0) 207 827 6184
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