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SMi’s 5th Annual Conference
Pharmaceutical Microbiology East Coast
April 27-28 2022 | Boston, USA
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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 jeopardise 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 2022 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.


To register your interest or to get involved please contact: eshambler@smi-online.co.uk
 

 

 

  • REVIEW implementation guidance and validation for efficient disinfectant efficacy programs
  • UNCOVER principles in best-practice and the benefits of a robust contamination control strategy
  • ADDRESS fungal mould contamination and risk-based tools to tackle spore spreading
  • DELVE into the sterility assurance assessment and holistic closure integrity testing
  • EXPLORE the impact of the ongoing pandemic and the changing face of the pharma industry
  • UNDERSTAND new unique case studies, from contamination control as it relates to microbiome products, to risk-based assessments of traditional microbiological tests

Heads of Aseptic Processing
Heads of Microbiology
Global Quality Directors
Heads of GMP Compliance
Quality & Compliance Heads
Microbiology Senior Specialists
Directors of Quality Control Biology
Quality Control Managers
Quality Assurance Managers
Lean Managers
Operations Managers
Heads of Site Compliance
Heads of Sterile Technology
Global Microbiology Analytical Experts
Cleanroom Managers
Regulatory Affairs Managers
Production Managers
Quality Systems Managers
 

Previous attendees include:

 

Allergy Therapeutics Ltd; AllergyTherapeutics; Associates of Cape Cod; Associates Of Cape Cod International; AstraZeneca; AstraZeneca PLC; Baxter; Baxter Healthcare Ltd; BioMerieux; bioMerieux UK Limited; BioPhorum; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH & Co. KG; Charles River EMD; Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna; Copan; Copan Group; Copan Italia SpA; CTL - Mat; David P Elder Consultancy; European Patent Office; Fagron; Freeline; Fresenius Kabi; Fresenius Kabi UK Ltd; GSK; GSK Vaccines; GW Pharma ; King's College London ; Kite Pharma ; Lonza; MeiraGTx; Meriagtx; Mettler Toledo; Mettler Toledo Ltd; Mettler-Toledo Ltd; Mettler-Toledo Thornton; MHRA; MIcrobiologics; Microgenetics Ltd; Novo Nordisk; Oxford Biomedica Ltd; Paul Ehrlich Institut; PHSS: Pharmaceutical & Healthcare Sciences Society; Reading Scientific Services Ltd; Reading Scientific Services Ltd (RSSL); Regeneron Pharmaceuticals Inc.; RSSL; Sanofi-Aventis Deutschland GmbH; SDA Pharma; Steris Corporation; Techniconsult Firenze SRL; University of Veterinary Medicine Vienna; VCCN/Brookhuis Applied Data Intelligence; Veltek Associates, Inc.;

 

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Jim Polarine

Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
View Bio

9:10 Designing an Efficient Disinfectant Efficacy Program

  • Review disinfectant efficacy validation and implementation guidance
  • How to leverage multi-site data to reduce redundancies in validation or verification and to efficiently qualify disinfectants without impacting the quality of the study
  • Case studies will be presented from two companies discussing global disinfectant efficacy studies that support and supplement site disinfectant efficacy programs
  • Hilary Chan

    Hilary Chan, Principal Quality Control Scientist, Takeda
    View Bio

    Stephen Yang

    Stephen Yang, Director, Global Sterile / Validation COE, Merck

    9:50 Implementing a Contamination Control Strategy

    Alison Laughlin

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

  • Elements of a Robust Contamination Control Strategy
  • Best Practices for Implementing a Contamination Control Strategy
  • Documenting the Contamination Control Strategy
  • The Benefits of a Well-Defined Contamination Control Strategy
  • 10:30 Morning Coffee

    11:00 A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

  • Case studies on fungal spore contamination in Cell and Gene Therapy Facilities will be covered
  • Investigative methods including risk assessments, fishbone diagrams and the five why’s will be discussed
  • Technologies for fungal spores’ control and methods to proactively prevent fungal outbreaks will be interactively discussed
  • Industry best practices for cleaning and disinfection of cell and gene therapy facilities will be highlighted
  • 11:40 Recombinant reagents for BET – regulatory landscape and their future in routine use

    Veronika Wills

    Veronika Wills, Manager, Technical Services, Associates of Cape Cod
    View Bio

    • Overview of the types of available recombinant technologies and key differences
    • The regulatory landscape around the use of recombinant reagents as alternatives to LAL reagents
    • Product specific method validation approach
    • The future applications of recombinant reagents
    • Automation of the use of recombinant reagents
     

    12:20 Cleaning Validation Lifecycle – Applications, Methods, and Controls

    Fred Ohsiek

    Fred Ohsiek, Sr Manager, Global Cleaning Validation SME, Novo Nordisk
    View Bio

    13:00 Networking Lunch

    14:00 Impacts of the SARS-CoV-2 pandemic on the biopharmaceutical industry

    Lynne Ensor

    Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel International
    View Bio

    • The impact of the COVID-19 pandemic on the following areas will be discussed during the presentation:
            o Regulatory Emergency Use Authorizations and Final Approval Process
            o Regulatory Manufacturing Facility Assessment and Inspections
            o Manufacturing Facility Design
            o Supply Chain Integrity Considerations

    14:40 Common Issues in The Sterility Assurance Assessment

    John Arigo

    John Arigo, Division of Microbiology Assessment Director, Office of Pharmaceutical Manufacturing Assessment / FDA
    View Bio

    • Introduction to FDA small molecule microbiology/ manufacturing
    • Common deficiencies seen in applications
    • Recommendations for applications to expedite approval

    15:20 Afternoon Tea

    15:50 Growth Modeling of Aseptic Process Simulation Contamination Events

    Austin Kuo

    Austin Kuo, Research Advisor – Sterility Assurance, Eli Lilly And Company
    View Bio

  • Exploring methods and benefits of performing mathematical modeling of microbiological growth when investigating aseptic process simulation (APS) contamination events
  • Translating APS contamination patterns into explainable inherent behaviors of microbes
  • Case studies of growth modeling being utilized to predict / confirm the failure mode resulting in the contamination events
  • 16:30 The best practice and biggest pitfalls in inspections

    Kashyap Bhatt

    Kashyap Bhatt, Manager GPV Quality Operations, Takeda

    • Assessing regulations specific to Microbiology and Environmental Monitoring
    • Exploring case studies in Quality culture and Media Fill
    • Insight into inspector audit expectations
    • Highlighting what to expect during an inspection and key preparation technique
    • How COVID has impacted inspections
    • What to expect during virtual inspections

    17:10 Chair’s Closing Remarks and Close of Day One

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    9:10 Case Study: Expediting Mold Contamination Investigations with the Use of Biofluorescent Particle Counting Technology

    Dawn Watson

    Dawn Watson, Director, Microbial Control, MSD
    View Bio

    • This presentation will provide an overview of the rapid microbiological technology used, specifically BFPC
    • It will provide a case study for the application of BFPC technology to support mold remediation in an aseptic processing facility
    • The presentation will review the benefits and outcomes yielded with use of the BFPC technology to support resolution of an investigation
    • The presentation will provide opportunities for additional use of the BFPC technology to ensure successful return to operation following major shutdowns, facility modifications or breaches

    9:50 Steps to eradicate undetected contaminations using bioburden anaerobic testing

    Kate Young

    Kate Young, Manager, QA Specialist Vector CMOs, Bristol Myers Squibb

  • With no standard optimized testing methods, it is possible for anaerobic contaminants to go undetected in biological manufacturing processes
  • This is a risk that could cause significant disruption to manufacturing processes
  • This presentation outlines testing options using case studies from 6 global pharmaceutical companies, who are members of the BioPhorum Microbial Control workstream
  • The recommendations were vetted via an independent and blinded peer-review process involving other leading industry experts
  • 10:30 Morning Coffee

    11:00 Microbial control: Risk assessment of traditional culture-based microbiological tests requiring contemporaneous verification

    Lena J Hoch

    Lena J Hoch, Microbiologist Specialist , GSK
    View Bio

    The FDA is particularly focused on the data integrity of microbial tests as these often use manual methods that could be open to error or fraud
    • A BioPhorum survey into this area found that more than 50% of members were doing second-person verification of tests to satisfy FDA scrutiny, but did not think the risk was being properly managed
    • The presentation looks at the fundamentals of ensuring microbiological test data integrity and proposes that a qualitative risk assessment is performed for the traditional, culture-based quality control tests that currently require verification by a second person. In addition, lab controls are recommended to ensure that testing is robust
    • One member company applied the risk assessment approach outlined in the paper and was able to remove 12 million second person verification samples from its global testing program. A case study also demonstrated that it is possible to save one to two full time equivalents if the risk-based approach is applied
    • The workstream members are now implementing this approach and sharing both operational experience and feedback at audit. The recommendations outlined are currently being considered for incorporation into an update of USP 1117

    11:40 Combination Product Sterility Assurance – A holistic approach from component through manufacturing

    Michael Song

    Michael Song, Associate Director, Takeda Pharmaceutical Company Limited
    View Bio

    • Developing a holistic container closure integrity (CCI) strategy from component level through manufacturing to finish good
    • Methods and approaches for primary container component selection and qualification
    • Container closure integrity testing (CCIT) to establish robust manufacturing processes
    • Altitude impact on sterile barrier and approaches to demonstrate sterility is maintained during air transportation

    12:20 Networking Lunch

    13:20 Panel Discussion: Assessing the ongoing coronavirus pandemic and the changing face of the pharmaceutical industry

    • How has the regulation changed in response to the pandemic?
              o Are these changes here to stay?
    • Can operational protocols be implemented in manufacturing facilities to ensure personnel safety and minimise viral transmission?
    • Has the pharmaceutical industry addressed flaws in the supply chain highlighted by the pandemic?
    • Do novel SARS-CoV-2 variants pose a future threat to the industry?
              o How do we best prepare for future outbreaks?

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

    Lynne Ensor

    Lynne Ensor, Vice President, RCS Head of Global Compliance, Parexel International
    View Bio

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab & US Pharmacopeia
    View Bio

    Mauro Giusti

    Mauro Giusti, Advisor, Site External Network, Eli Lilly Italia
    View Bio

    14:00 Isolator technology: from project to operations

    Mauro Giusti

    Mauro Giusti, Advisor, Site External Network, Eli Lilly Italia
    View Bio

    • Sharing experiences on multiple filling lines with Isolator technology
    • Recommendations based on experience
    • Specific case studies during operations
    • Discussion on technology options for the process with sterility assurance implications
     

    14:40 Contamination Control as it relates to Microbiome Drug Product manufacture -- Misconceptions and grey areas in non-sterile product manufacturing

    Sean OBrien

    Sean OBrien, Director, Quality Control External Operations, Seres Therapeutics

    Defining the human microbiome as a symbiotic ecological community and its role in human health
    • Ascertaining that an ecological community is implicitly a densely interconnected living system
    • The challenges associated with eliminating extraneous bacteria from drugs to ensure patient safety without compromising the microbiome drug product
    • Addressing material management as a crucial component of certified cleaning strategy
    • The importance of a holistic, homogenously intricate cleaning strategy and avoiding a focus on operation protocol and procedural controls

    15:20 Afternoon Tea

    15:50 Learning to control B. cepacia – A USP perspective

    Donald Singer

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab & US Pharmacopeia
    View Bio

    • What have we learned about B. cepacia?
    • The trouble with undefined terminology
    • When to use USP general method <60>
    • What can we learn from USP <1115> to mitigate Bcc problems?
     

    16:30 Microbiological quality control for pharmaceutical water by Rapid Microbiological Methods (RMM)

    Yoko Nakai

    Yoko Nakai, Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter
    View Bio

    • The GMP Committee for Aseptic Products of the PDA Japan chapter will present case studies applying RMM, for monitoring microbial quality of pharmaceutical water
    • Two different methods are implemented, BFPC (Bio Fluorescent Particle Counter) and high-sensitivity ATP method
    • Discussion will be held based on the data obtained at the pharma factory over several years and the laboratory of the system supplier
    • The case studies will cover setting an action/alert level for achieving GMP operation
     

    17:10 Chair’s Closing Remarks and Close of Day Two

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    View Bio

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    FEATURED SPEAKERS

    Alison Laughlin

    Alison Laughlin

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

    Austin Kuo

    Research Advisor – Sterility Assurance, Eli Lilly And Company
    Dawn Watson

    Dawn Watson

    Director, Microbial Control, MSD
    Donald Singer

    Donald Singer

    Chair, General Chapters - Microbiology Expert Committee, Ecolab & US Pharmacopeia
    Hilary Chan

    Hilary Chan

    Principal Quality Control Scientist, Takeda
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    John Arigo

    John Arigo

    Division of Microbiology Assessment Director, Office of Pharmaceutical Manufacturing Assessment / FDA
    Kashyap Bhatt

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Lena J Hoch

    Lena J Hoch

    Microbiologist Specialist , GSK
    Lynne Ensor

    Lynne Ensor

    Vice President, RCS Head of Global Compliance, Parexel International
    Mauro Giusti

    Mauro Giusti

    Advisor, Site External Network, Eli Lilly Italia
    Michael Song

    Michael Song

    Associate Director, Takeda Pharmaceutical Company Limited
    Sean OBrien

    Sean OBrien

    Director, Quality Control External Operations, Seres Therapeutics
    Veronika Wills

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod
    Yoko Nakai

    Yoko Nakai

    Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter

    Alison Laughlin

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

    Alison Laughlin is the Associate Director of North America Regional Quality & Global Sterility Process Assurance for the Animal Health Division of Boehringer Ingelheim. She has over 25 years of technical expertise in sterility assurance, environmental monitoring, and microbiological testing of sterile pharmaceuticals, vaccines, and medical devices. Her expertise includes leading root cause investigations for complex microbiological issues and improving regulatory compliance and product quality. She currently develops divisional policies and procedures and provides quality support to the North America Boehringer Ingelheim Animal Health division sites and sterility assurance support to the global sites. Her prior roles included leadership positions in the Microbiology Laboratories at Baxter Healthcare, Hospira, and Wyeth. Alison holds a bachelor’s degree in Biology from Rutgers University, New Jersey.

    Austin Kuo

    Research Advisor – Sterility Assurance, Eli Lilly And Company
    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.

    Dawn Watson

    Director, Microbial Control, MSD
    Dawn Watson


    Dawn is a Director supporting Microbial Control at MSD. She works in the Sterile & Validation Center of Excellence managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 26 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing and research and development throughout her career with MSD.
     

    Donald Singer

    Chair, General Chapters - Microbiology Expert Committee, Ecolab & US Pharmacopeia
    Donald Singer

    Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member of this committee since 2000. Don is a member of the European Pharmacopeia Group 1 Microbiology Committee. He is also chair of the PDA Task Force for the revision of Technical Report titled, “Pharmaceutical Package Integrity Testing”, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is also an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

    Fred Ohsiek

    Sr Manager, Global Cleaning Validation SME, Novo Nordisk
    Fred Ohsiek

    Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his bachelor’s in chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk.
    His cleaning validation experience includes risk assessments, cleaning development, validation, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved drug substance and drug product manufacturing start-up, remediation, legacy justification, and increasing manufacturing capability. He has created lean CV strategies for document structure/flow and execution in every aspect of the cleaning validation process.
    He was one of the authors on the new ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls and the cleaning validation acceptance criteria chapter lead.

    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.

    Jim Polarine

    Senior Technical Service Manager, Head of Microbiology & Sterile Technology, STERIS Corporation; Sanofi
    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 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, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager 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 of Microbiology Assessment Director, Office of Pharmaceutical Manufacturing Assessment / FDA
    John Arigo

    Dr. Arigo is the Director of the Division of Microbiology 1 in the Office of Pharmaceutical Manufacturing Assessment at the FDA. His division assesses the sterility assurance and manufacturing submissions to support ANDA, NDA, and INDs. He began his career with the Office of Generic Drugs Microbiology team in 2008 and has been involved in multiple reorganizations to the current state. Dr. Arigo obtained his Ph.D. from The Johns Hopkins University School of Medicine.

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Kashyap Bhatt

    Kate Young

    Manager, QA Specialist Vector CMOs, Bristol Myers Squibb
    Kate Young

    Lena J Hoch

    Microbiologist Specialist , GSK
    Lena J Hoch

    Lena J Hoch is a Microbiologist Specialist with GlaxoSmithKline in Pennsylvania where she has held various positions over the past six years specializing in microbiology and supporting quality control. Prior to these roles, she attended University of the Sciences in Philadelphia and earned a BS in Biology with minors in Microbiology and Humanities. She is a subject matter expert for GSK's Quality Control Microbiology department and currently specializes in low endotoxin recovery and project management activities.

    Lynne Ensor

    Vice President, RCS Head of Global Compliance, Parexel International
    Lynne Ensor

    Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been employed there since August 2019. As a 21-year veteran of the U. S. Food and Drug Administration (FDA), her areas of expertise include biopharmaceutical sterile product manufacturing and testing (CMC and cGMP), risk assessment and mitigation strategies, data integrity assessment, regulatory policy and guidance development, as well as remediation strategies for product and facility challenges (e.g., resolving consent decrees, warning letters, 483 observations, and drug shortages). While serving as the Deputy Director (Acting) in the Office of Process and Facilities (OPF) within FDA/Center for Drug Evaluation and Research’s (CDER) Office of Pharmaceutical Quality (OPQ), she was responsible for new, generic and biologic drug product quality review and facility assessment. Dr. Ensor’s previous FDA positions included serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Science’s New and Generic Drug Product Quality Microbiology staff, Director of the Office of Generic Drugs’ Division of Microbiology and as a CDER master CMC reviewer. In addition to Dr. Ensor’s regulatory experience, Lynne was employed at Roche Biomedical Laboratories, served as a post-doctoral research fellow at the University of Maryland at Baltimore’s School of Medicine, and served as a script consultant for the Discovery Channel. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

    Mauro Giusti

    Advisor, Site External Network, Eli Lilly Italia
    Mauro Giusti

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is Board Certified by National Chemist association and he is Board certified as Technical Director (Qualified Person) by the Italian Minister of Health.
    After serving as Army Officer, he joined Eli Lilly at the Italy manufacturing plant site in 1988. Over the 33 years with Eli Lilly, Dr. Giusti has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, QC, QA, Operations, Technical Director/Qualified Person, Six Sigma Champion, Science and Technology, Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.
    Among the several experiences with Lilly, he has worked in USA from 1992 to 1994 and in United Kingdom from 1997 to 1999..
    Since late 2003, he has had responsibility for Lilly Italy TSMS (Technical Svcs/Mfg Science Department), with responsibility for Metrology, C&Q of facilities, utilities and equipment, Sterility Assurance, Process Validation, set-up of new manufacturing processes and of new manufacturing technology for Biotech products, including automatic assembly of disposable Insulin pens and Autoinjectors. In September 2009 he also added to his TSMS duties, the responsibility for Manufacturing Sourcing and Vendor Management.
    In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (Universities, Pharma Associations, etc..) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.
    For more than 12 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for he Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB).
     

    Michael Song

    Associate Director, Takeda Pharmaceutical Company Limited
    Michael Song

    Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Sean OBrien

    Director, Quality Control External Operations, Seres Therapeutics
    Sean OBrien

    Stephen Yang

    Director, Global Sterile / Validation COE, Merck
    Stephen Yang

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod
    Veronika Wills

    Veronika has over 13 years experience in endotoxin testing, and currently manages the global technical team at ACC and is based at ACC’s US Headquarters in East Falmouth, Massachusetts . Veronika is a subject matter expert when it comes to endotoxin testing and often provides expert sessions at global events focused on BET products and processes. Most recently Veronika has been speaking on the topic of recombinant technology as it relates to BET in the industry and abroad. Veronika is a key contributor to ACC’s sustainability initiatives and spokesperson on ACCs related projects, products and services.

    Yoko Nakai

    Rapid Microbiological Method RMM Research Group Representative, PDA Japan chapter
    Yoko Nakai

    The GMP Committee for Aseptic Products is one of the technical committees of PDA Japan chapter. It is made up of ten groups, each with experts in their respective fields who are actively engaged in research and discussion. Study results of each group have been reported at annual microbiology symposium which the committee hosted and provided participants state-of-art and practical information.
    One of the groups, the Rapid Microbiological Method (RMM) Research Group consists of RMM users (pharmaceutical companies) and RMM system suppliers. By their collaboration, they provide application and implementation case studies from scientific, engineering, and regulatory point of view, and contribute to further improvements of quality and safety of pharmaceutical products by wide use of RMM in Japan.
    The speaker, Yoko Nakai represents the GMP Committee for Aseptic Products. She has been a project manager for RMM system development and applications at HORIBA Advanced Techno, Co., Ltd. since 2017. HORIBA has been a member of RMM implementation study team with Bayer Yakuhin, Ltd., and Azbil Corporation.
     

    Sponsors

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Microbial risk-assessment and cleaning validation
    Workshop

    Microbial risk-assessment and cleaning validation

    Sheraton Boston Hotel
    29th April 2022
    Boston, USA

    USP Microbiology 2022 – Keeping Up with Standards
    Workshop

    USP Microbiology 2022 – Keeping Up with Standards

    Sheraton Boston Hotel
    29th April 2022
    Boston, USA

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    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.
    HOTEL BOOKING FORM

    Conference Chair Letter

    Download

    Chair & Speaker Biographies

    Download

    Workshops

    Download

    Brochure

    Download

    Past Attendees

    Download

    Past Speaker Presentation - Dr Johannes Reich, Microcoat

    Download

    Past Speaker Presentation - John Arigo, FDA

    Download

    Past Speaker Presentation - Kashyap Bhatt, Takeda

    Download

    Past Speaker Presentation - Jim Polarine, STERIS

    Download

    Past Speaker Presentation - Hilary Chan, Takeda

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    Sponsors


    Associates of Cape Cod

    Sponsors
    http://www.acciusa.com/acc/index.html

    ACC Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1g3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    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.


    Microbiologics

    Exhibitors
    http://www.Microbiologics.com

    Microbiologics is the world’s leading experts and go-to collaborators for biological products and services, focused on protecting the health and safety of people around the world. We partner with pharmaceutical, biotechnology and medical device companies to bring new life-changing diagnostic assays, drugs and vaccines to market safely and efficiently. With a highly collaborative approach, we provide contract research, antimicrobial and antiviral testing, assay development, biomaterial design services and more. As a trusted industry partner with more than 5 decades of experience, our knowledgeable team is ready to answer your questions and get started with designing a customized program to fit your unique project needs.


    Media Partners


    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.


    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.


    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


    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.


    Biocompare

    Official Media Partner
    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.

    Media Partners


    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.


    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.


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    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.


    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


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    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.


    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.


    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!


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Hospital & Healthcare Management

    Supporters
    https://www.hhmglobal.com/media-pack



    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


    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.


    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


    Pharmaceutical-Review

    Supporters
    http://www.pharmaceutical-review.com

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.

    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

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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, SMI 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@smi-online.co.uk

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
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    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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