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Pharmaceutical Microbiology USA
April 26 - April 27, 2023
Pharmaceutical Microbiology USA

SAE Media Group’s 6th Annual Conference
Pharmaceutical Microbiology USA
April 26-27 2023 | Boston, USA

Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardize product batches.

 

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.


On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding -- join leading experts in 2023 to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insight into this corner of the field.
 

FEATURED SPEAKERS

Alison Laughlin

Alison Laughlin

Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
Austin Kuo

Austin Kuo

Senior Director - Sterility Assurance - TS/MS, Eli Lilly
Donald Singer

Donald Singer

USP General Chapter Committee Microbiology Chair, US Pharmacopeia
Erika Pfeiler

Erika Pfeiler

Branch Chief, FDA
Gurpreet Ganda

Gurpreet Ganda

Senior Manager, QC Microbiology, Roche
Jason  McGuire

Jason McGuire

Vice President, Global Quality, Fagron
Jim Polarine

Jim Polarine

Senior Technical Service Manager, Steris Corporation
John Arigo

John Arigo

Division Director, FDA
John Duguid

John Duguid

Executive Director, Research & Development, Vericel Corporation
Michael Song

Michael Song

Associate Director, Takeda Pharmaceuticals
Shelton Sparks

Shelton Sparks

Product Manager Testing Solutions, Lonza

Alison Laughlin

Associate Director, Regional Quality NA & Sterility Process Assurance, Boehringer Ingelheim
Alison Laughlin

Austin Kuo

Senior Director - Sterility Assurance - TS/MS, Eli Lilly
Austin Kuo

Mr. Kuo earned a Masters in Microbiology from Michigan State University and brings over 20 years of experience in parenteral manufacturing, with a focus on sterility assurance and environmental monitoring programs. He has led Quality and Technical Services organizations supporting environmental monitoring, aseptic process simulations (media fills), aseptic technique, personnel gowning and hygiene, aseptic interventions, sterile filtration validation, sanitization programs and agent validation, and sterility assurance risk assessments supporting parenteral operations.

Donald Singer

USP General Chapter Committee Microbiology Chair, US Pharmacopeia
Donald Singer

Don Singer is Senior Microbiology Technical Consultant, North America, for Ecolab, and a Fellow in the American Society for Quality. He was formerly a GSK Senior Fellow. Don is currently Chair of the USP General Chapters - Microbiology Committee of Experts and has been a member since 2000. He is a Certified GMP Professional, a Certified Specialist Microbiologist and is a member of the European Pharmacopeia Group 1 Microbiology Committee. Don is also an adjunct professor in the Biopharmaceutical Quality graduate program at the University of Maryland Baltimore County. He was an author of the PDA Technical Report for “Contamination Control Strategy” along with two other technical reports, one for Pharmaceutical Package Integrity and one for Objectionable Microorganisms. Don’s career spans over 40 years of research and quality control.

Erika Pfeiler

Branch Chief, FDA
Erika Pfeiler

Gurpreet Ganda

Senior Manager, QC Microbiology, Roche
Gurpreet Ganda

Hilary Chan

Principal Quality Control Scientist, Takeda
Hilary Chan

Hilary Chan

Principal Quality Control Scientist, Takeda
Hilary Chan

Hilary Chan is a Principal Quality Control Scientist in Global Microbiology Management at Takeda and is based out of Lexington, MA. In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead for Takeda. She is an invited speaker at industry conferences and has authored various scientific publications. Hilary has over 20 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

Jason McGuire

Vice President, Global Quality, Fagron
Jason  McGuire

Jason has spent nearly 20 years in the health care industry serving in many roles with a particular focus on Quality control operations, Quality assurance and regulatory support. He’s a microbiologist by education and expertise, spending 2 years on the bench developing anaerobic microbial catalysts for fuel ethanol production. For the last 15 years, he has worked with non-sterile and sterile compounding facilities, national health systems, medical device, biotechnology and pharmaceutical companies helping them troubleshoot and bringing resolution to complex challenges.

Jim Polarine

Senior Technical Service Manager, Steris Corporation
Jim Polarine

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators with FDA, MHRA, HPRA, ANVISA, and ANMAT as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

John Arigo

Division Director, FDA
John Arigo

John Duguid

Executive Director, Research & Development, Vericel Corporation
John Duguid

JOHN DUGUID is Senior Director, Research & Development at Vericel Corporation. As
a Principal Scientist at Genzyme, he was responsible for developing and implementing
rapid microbiological assays and had previously managed QC cell therapy operations.
Prior to Genzyme, he worked as an analytical chemist at Abbott Laboratories and Arthur
D. Little. Mr. Duguid received his BS in Chemistry from the University of Michigan

Kenneth Paddock

Quality Director, Sterility Assurance, Baxter
Kenneth Paddock

Kim Sobien

Contamination Control Lead:, GSK
Kim Sobien

Laurie Boyd

Senior Microbiologist/Team Leader, Alkermes, Inc.
Laurie Boyd


I received my undergraduate degree from Bowling Green State University in Biology and my graduate degree in Business Management from The University of Phoenix. I have worked in the Pharmaceutical industry as a Quality Control Microbiologist and Chemist for 20 years. I have worked for Pharmacia and Upjohn, Pfizer and Alkermes. I have a background in Sterile and Non –sterile manufacturing which include Biologics, Orals, API and Injectables.
 

Li Wei Chan

Manager Microbiology, MSD Pharma (Singapore) Pte Ltd
Li Wei Chan

Liz Brockson

Aseptic Processing and Sterility Assurance Lead, Takeda
Liz Brockson

Michael Song

Associate Director, Takeda Pharmaceuticals
Michael Song

Shelton Sparks

Product Manager Testing Solutions, Lonza
Shelton Sparks

Shelton Sparks, product manager for Lonza Testing Solutions, supports the endotoxin detection portfolio. Following management of Lonza’s PyroGene® rFC Assay and instrumentation, Shelton now focuses on the PyroTec® PRO Automated Endotoxin Testing System and WinKQCL® Software solutions that help customers error-proof and future-proof their QC testing programs. He joined Lonza in 2017 as a research engineer before transitioning into his current role. Shelton has a BS in Chemical Engineering from the University of Alabama and is currently pursuing a MBA from Lehigh University.

 

sponsors


Associate Director, Regional Quality NA & Sterility Process Assurance
Boehringer Ingelheim
Senior Director - Sterility Assurance - TS/MS
Eli Lilly
USP General Chapter Committee Microbiology Chair
US Pharmacopeia
Branch Chief
FDA
Senior Manager, QC Microbiology
Roche
Principal Quality Control Scientist
Takeda
Principal Quality Control Scientist
Takeda
Vice President, Global Quality
Fagron
Senior Technical Service Manager
Steris Corporation
Division Director
FDA
Executive Director, Research & Development
Vericel Corporation
Quality Director, Sterility Assurance
Baxter
Contamination Control Lead:
GSK
Senior Microbiologist/Team Leader
Alkermes, Inc.
Manager Microbiology
MSD Pharma (Singapore) Pte Ltd
Aseptic Processing and Sterility Assurance Lead
Takeda
Associate Director
Takeda Pharmaceuticals
Product Manager Testing Solutions
Lonza

Sponsors

Exhibitors

Official Media Partner

Supporters

VENUE

Courtyard by Marriott Boston Downtown

Boston, USA

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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Past Attendees List

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Full Agenda

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Chair Letter

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Speaker Biographies

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Short Agenda

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Sponsors


Lonza

Sponsors
http://bioscience.lonza.com

Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza offers fully integrated software solutions and products for quantitative endotoxin detection, whether traditional, sustainable or automated methods are needed. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin detection products and paperless QC microbiology, software and services that support the critical needs of regulated manufacturing environments.

Exhibitors


Bioscience International

Exhibitors
http://www.biosci-intl.com

The newest generation of SAS microbial air monitors, for ensuring full compliance with ISO 14698, cGMP and other international monitoring guidelines will be displayed.


Ecolab

Exhibitors
https://en-uk.ecolab.com/

Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.


Media Partners


Rapid Microbiology.com

Official Media Partner
https://www.rapidmicrobiology.com

rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.


Labcompare

Official Media Partner
http://www.labcompare.com

Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


American Pharmaceutical Review

Official Media Partner
http://www.americanpharmaceuticalreview.com

Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


Medical Design Briefs

Official Media Partner
http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

Media Partners


Drug Discovery Today

Supporters
http://www.drugdiscoverytoday.com/

Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


Biocompare

Supporters
http://www.biocompare.com

Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


IPI

Supporters
http://www.ipimediaworld.com

IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


Technology Networks

Supporters
http://go.technologynetworks.com/subscribe-to-newsletters

Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


pharmaphorum

Supporters
http://www.pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


BioChem Adda

Supporters
https://www.biochemadda.com/

BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


IBI - International Biopharmaceutical Industry

Supporters
http://www.biopharmaceuticalmedia.com

IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


Genetic Engineering News

Supporters
http://www.genengnews.com

Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


Pharma Journalist

Supporters
http://www.pharmajournalist.com

Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


Contract Biotechnology

Supporters
http://www.contract-biotechnology.com

Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


SelectScience

Supporters
http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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