10times
28 - 29 Oct 2020Ended

Pharmaceutical Microbiology East Coast - Virtual Conference

About 24Sessions 18SpeakersExhibitorsReviewsPhotos

Estimated Turnout

upto 100
Delegates
Based on previous editions

Editions

28 - 29 Oct 2020

Frequency

Not Available
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SMi is proud to announce the 3rd Annual Pharmaceutical Microbiology East Coast Virtual Conference taking place on October 28th – 29th, 2020. .. Read more The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, innovative approaches in ATMP facilities, this industry is ever expanding.ndustry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation. Pharmaceutical Microbiology East Coast will discuss the ongoing complication of personnel derived contaminations from the FDA. Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel. • Introduction of the FDA’s impending guidance on this topic • Regulatory Expectations for microbial control of non-sterile drugs • Case studies of microbiological contamination of non-sterile drug products to demonstrate the impact on product quality and the manufacturing process.

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Wed, 28 Oct

Chair's Opening Remarks
Lynne Ensor
Lynne Ensor Vice President, Technical, Parexel Internatio..
Wed, 28 Oct
Session
Microbiological Quality Considerations in Non-sterile Pharmaceutical Manufacture and Control of BCC
Lynne Ensor
Lynne Ensor Vice President, Technical, Parexel Internatio..
Wed, 28 Oct
Session
Evaluating the ongoing complications of personnel derived contaminations
Maria Jose Lopez Barragan
Maria Jose Lopez Barragan Founder, Barragan BioConsulting, formerly CMC..
Wed, 28 Oct
Break
Networking Break
Wed, 28 Oct
Session
Adopting the rFC (recombinant Factor C) assay for endotoxin detection in your laboratory
Lakiya Wimbish
Lakiya Wimbish Product Manager
Wed, 28 Oct
Session
Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products
Shabnam Solati
Shabnam Solati Co-Founder, CEO
Wed, 28 Oct
Session
Recent Advances and New Developments in Mycoplasma Control of Blood-derived Cell-based Medicinal Products
Renate Rosengarten
Renate Rosengarten Professor and Chair of Bacteriology and Hygie..
Wed, 28 Oct
Lunch
Networking Lunch
Wed, 28 Oct
Session
Mycoplasma Testing: Past, Current, and Future State
Kenneth Tai
Kenneth Tai QC Scientist
Wed, 28 Oct
Session
Container Closure Integrity Evaluation: USP Perspective
Leslie Furr
Leslie Furr Associate Scientific Liaison
Wed, 28 Oct
Session
Container Closure Integrity and Controls Strategies Ensuring Product Sterility
Michael Song
Michael Song Associate Director
Wed, 28 Oct

Chair’s Closing Remarks and Close of Day One
Lynne Ensor
Lynne Ensor Vice President, Technical, Parexel Internatio..
Thu, 29 Oct

Chair's Opening Remarks
Lynne Ensor
Lynne Ensor Vice President, Technical, Parexel Internatio..
Thu, 29 Oct
Session
Culturing Contamination Prevention - Building a Sustainable Microbial Control Program from the Ground Up
Hilary Chan
Hilary Chan Principal QC Scientist
Maria Dunnells
Maria Dunnells Right First Time Program Manager, Takeda Phar..
Thu, 29 Oct
Session
Alternative methods for endotoxin testing: focus on equivalency of recombinant reagents to lysate reagents
Veronika Wills
Veronika Wills Manager, Technical Services, Associates of Ca..
Thu, 29 Oct
Break
Networking Break
Thu, 29 Oct
Session
A Sustainable, Ecological and Efficient rFC Endotoxin Testing Solution
Brendan Tindall
Brendan Tindall Global Solutions Manager and Program Director
Thu, 29 Oct
Session
Microbial Control & Sterility for Biotech Products: What The Regulators Want to Know
Scott Nichols
Scott Nichols Quality Compliance Lead
Thu, 29 Oct
Session
Panel Discussion: COVID-19 and Contamination Control
Diane Raccasi
Diane Raccasi Principal Consultant
Hilary Chan
Hilary Chan Principal QC Scientist
Thu, 29 Oct
Lunch
Networking Lunch
Thu, 29 Oct
Session
Global Impact Assessment Process for Aseptic Process Simulations
Austin Kuo
Austin Kuo Principal Research Scientist, Sterility Assur..
Thu, 29 Oct
Session
Common Myths and Urban Legend Regarding Cleaning and Disinfection
James N. Polarine Jr
James N. Polarine Jr Senior Technical Service Manager
Thu, 29 Oct
Session
Audit and Trends
Kashyap Bhatt
Kashyap Bhatt Manager GPV Quality Operations
Thu, 29 Oct

Chair’s Closing Remarks and Close of Day Two
Lynne Ensor
Lynne Ensor Vice President, Technical, Parexel Internatio..
Speaker
Austin Kuo

Austin Kuo

Principal Research Scientist, Sterility Assurance
Speaker
Brendan Tindall

Brendan Tindall

Global Solutions Manager and Program Director
Speaker
Diane Raccasi

Diane Raccasi

Principal Consultant
Speaker
Hilary Chan

Hilary Chan

Principal QC Scientist
499 USD Visitor/General
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