Interactive training session on cleanrooms and environmental monitoring at Pharmaceutical Microbiology USA

The seventh in its series, Pharmaceutical Microbiology USA will take place in San Diego, on the 8th and 9th June 2017.

The 2017 agenda will provide, 16 thought provoking presentations, 17 leading expert speakers, 2 pre-conference workshops and an extended interactive training session.

Morgan Polen the Subject Matter Expert on Contamination Control from Microrite will be hosting the training session on 'Effects of cleanrooms and barrier systems on environmental monitoring data'.

Recent warning letters show that manufacturers of aseptic products are receiving the most 483s; many are related to smoke studies. Smoke / Airflow Visualization tests are often performed by third party certifiers. However, per FDA guidance, dynamic in-situ air pattern analysis is more complex. These studies should be investigative and effective at identifying design flaws or airflow issues. They should be performed using the correct type of smoke, smoke density, and camera angles. Therefore this exclusive one hour interactive training session will cover:

• Regulations and guidelines related to smoke studies
• Types of smoke (and equipment) used for smoke studies-pros and cons
• Execution of an investigative smoke study
• Case studies with videos of bad airflows and barrier system flaws
• Practical demonstration of smoke vs fog
• Discussions on 483s related to smoke studies
• Mistakes made during environmental monitoring in barriers with inadequate laminar flow that lead to excursions.

Alongside hosting the extended training sessions, Microrite will be providing a presentation throughout the two day conference where they will be joined by GSK, Bimeda, Sanofi, Amgen, Excellent Pharma Consulting, Renaissance Pharmaceuticals, Takeda, Vericel Corporation, Roche, Merck and more. All of the speakers have been carefully handpicked to provide insightful presentations from industry experts who will share recent case studies and discuss the developing trends in the field of pharmaceutical microbiology.

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/openpr

Pharmaceutical Microbiology USA is sponsored by Charles River and Rapid Microbiosytems

For sponsorship packages: Contact Alia Malick +44 (0) 207 827 6168 or e-mail amalick@smi-online.co.uk.

For delegate enquiries: Contact Fateja Begum on +44 (0) 20 7827 6184 or email fbegum@smi-online.co.uk

For media enquiries, contact Zoe Gale on +44 (0) 20 7827 6138 or zgale@smi-online.co.uk

Pharmaceutical Microbiology USA
8 - 9 June 2017
San Diego, California, USA
www.pharma-microbiology-usa.com/openpr
Contact e-mail: zgale@smi-online.co.uk
Contact tel: +44 (0) 207 827 6184
#smimicrobiology

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This release was published on openPR.