3rd Annual Pharmaceutical Microbiology West Coast Conference

3rd Annual Pharmaceutical Microbiology West Coast Conference is organized by SMi Group Ltd and will be held from Jun 05 - 06, 2019 at Hyatt Regency Mission Bay Spa And Marina, San Diego, California, United States of America.

Who Should Attend
Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager - Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist, Analytical Standards Specialist

Why you should attend:
To develop a microbial contamination control strategy and assess effectiveness of all the control and monitoring measures employed, myriad risk factors should be considered holistically. Microbial contamination risk assessments cannot be considered individually; all aspects from facility design to product release should be considered by fully understanding:
• Contamination due cleanroom and barrier system integration flaws
• How material and personnel flows can become a source of contamination
• Cleaning and disinfection gaps can contaminate facility and manufacturing equipment
• How gown management and gowning procedures can become a source of contamination
• Where in the process contamination can occur and the efficiency of removal methods
• Efficiency of monitoring equipment and methods
• Understanding objectionable microorganisms
• Microbiology laboratory issues that can contaminate tests

Conference Overview:
The pharmaceutical microbiology field is an ever-present constant in almost all areas of pharmaceuticals. We are experiencing a period of rapid change, with new regulatory considerations to implement into our environmental monitoring programmes, new technologies to improve processes and novel validation techniques.

Join us as we delve into the current evolving issues facing this industry, such as: risk-based approaches to aseptic processing, methods of contamination prevention, creating risk-based environmental monitoring programmes, water monitoring and treatment.

Workshops:
• Contamination Control: A Holistic Approach
• A holistic approach to microbial impurities, endotoxins and LER

Key Highlights and Topics:
• Discuss how to overcome challenges following RMM implementation 
• Hear the developments in creating an effective contamination control strategy
• Evaluate novel methods for endotoxin testing
• Explore strategies to create effective EM programmes to ensure compliance 
• Investigate a case of sterility failure and determine the entry point of contamination
• Contamination Control and Microbial, Identification 
• Endotoxin Testing and LER
• Environmental Monitoring and Rapid Microbial Methods
• Contamination Control considerations for special Drug Products 

Plus 2 half day interactive workshops on Tuesday, June 4th 2019: 
A: Assessing a Holisitic Approach to Microbial Contamination Control - Microrite 
B: Reviewing the Road Map to a Holistic Approach to Microbial Impurities, Endotoxins and LER. Led by: Genentech

Time: 08:30 to 16:30

Speakers: CHAIRED BY: Ziva Abraham, CEO, Microrite, Chris Knutsen, Associate Director, Microbiology, Bristol Myers Squibb, Ren-Yo Forng, Scientific Director, Amgen, Lucia Clontz, Quality Director, Xellia Pharmaceuticals, Anita Bawa, Director of Quality Control, Bayer, Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Genentech, Irving Ford, Head of CAR T QC Laboratories, Celgene