Home
overview

SMi is proud to announce the 4th Annual Pharmaceutical Microbiology East Coast Conference taking place on April 28th – 29th, 2021.

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 -- this industry is ever expanding. Join leading 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 complications of contamination control in controlled manufacturing environments. Gain essential insight into the microbial monitoring of pharmaceutical grade water systems from Pfizer and Novo Nordisk, discuss the frequent issues encountered in sterility assurance assessments from an active member of the FDA, and reach an expert understanding of risk-based cleaning regimes and operator protocols.

  • EXPLORE the latest advancements in robust risk-based disinfection strategies for effective cleaning and microbe elimination
  • INVESTIGATE the extensive and complex regulatory landscape alongside the regulators
  • DELVE into recent case studies delivered by experts in microbial monitoring and agile contamination control programs
  • ATTAIN expert tuition in new quality risk management tools for contamination control and the latest revisions in the US Pharmacopoeia at the post-conference workshops


 

The SMi Virtual Conference Platform will deliver the following benefits:

  • Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
  • Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
  • Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
  • Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality
  • Validation Managers
  • Senior Microbiologists
  • Quality Control Managers
  • Quality Assurance Experts
  • Leaders in Sterility Assurance
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers

 

Amneal Pharmaceutical; Amneal Pharmaceuticals LLC; Analytical Lab Group LLC; Associates of Cape Cod; Association of Cape Cod, Inc; Atara Biotherapeutics; Banelle; Baxter Corporation; bioMerieux Industry; bioMerieux, Inc.; Bioscience International; BioTekPro AB; Biotherpeutics; BioVigilant Systems; Bristol Myers Squibb; Charles River; CTL - Mat; DuPont; DuPont de Nemours Luxembourg sarl; Dupont Personal Protection; Eagle Analytical Services (Former FDA); Eli Lilly And Company; Emergent Biosolutions; Genentech; ImmuneBiotech AB; Infinity Laboratories; InnovaPrep; International Serum Industry Association; Ipsen; Lantheus Medical Imaging; Lonza; Lonza Walkersville, Inc.; Merck; Meridian Medical Technologies; Mettler Toledo; Microbiological Consulting, LLC; Microrite, Inc.; Novartis Pharmaceuticals Corporation; Novatek International; Ocular Therapeutix; Organogenesis Holdings Incorporated; Pfizer; Pfizer Inc; Pharmaceutical and Healthcare Sciences Society; Pharmalucence, Inc.; Regeneron; Regeneron Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme; SCA Pharma; Seres Therapeutics; Steris Corporation; Sun Pharma Boston; Takeda; Takeda Pharmaceuticals; United Therapeutics; University Of Calgary; University Of Guelph; University of Veterinary Medicine Vienna; Vericel Corporation; Zeteo Tech LLC;
 

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

Lynne Ensor

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

9:10 Manufacturing facility assessments during COVID Pandemic

Qiao Bobo

Qiao Bobo, Division Director, FDA
View Bio

• Introducing the changes to the manufacturing facility assessment to support application required in light of the COVID Pandemic
• Insight into how the FDA CDER Office of Pharmaceutical Quality has evolved its approaches to continue manufacturing facility assessments
• Recommendations to manufacturers for a successful remote manufacturing facility assessment
 

9:50 Contamination Control Strategy for the Facility of the Future

Sean OBrien

Sean OBrien, QA Director, Contamination Control, Sanofi
View Bio

  • The fundamentals of the Contamination Control Strategy for a drug substance biomanufacturing plant which employs single use technology and aseptic connections
  • Establishing the level of environmental control through the various components of Environmental Qualifi cation studies and then assessing through the routine Environmental Monitoring program
  • Environmental data, including excursions and trends, are continually evaluated by QA and discussed at reoccurring cross functional meetings thus ensuring the appropriate response to contamination events
  • Contamination Control is maintained through embedding quality into the process and on the shop floor
  • 10:30 Morning Coffee

    11:00 Emergency Use Authorization: Understanding a Regulatory Strategy Weapon Used to Battle a Pandemic

    Lynne Ensor

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

    • Describing EUA approaches developed by global regulatory health authorities
    • Understanding how EUA authority could be applied
    • Case studies: Application of EUA authority to combat COVID-19

    11:40 Cleanroom Operator Management

    Matts Ramstorp

    Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB
    View Bio

    • The human being as a source of contaminants
    • Choosing the ideal operator
    • Training, retraining, monitoring and control
    • Cleanroom garments
    • Instructions and routines
     

    12:20 Networking Break and Virtual Exhibit Hall Open

    13:20 Analytical Method Validation in the Microbiology Lab

    Laurie Boyd

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

    • Define the meaning of Method Validation vs. Method Verification
    • Learn about the current regulatory and compliance requirements
    • Establish resources to complete a solid method validation portfolio for your regulators
    • Bonus: This session will highlight some of the resources available to help guide your method validation needs in the Microbiology Lab
     

    14:00 Serum Use Today – An Update

    Rosemary Versteegen

    Rosemary Versteegen, CEO, International Serum Industry Association

    • Tools for better characterization of Bovine Serums
    • Human serum issues and concerns
    • Risk mitigation for adventitious agents
    • Impact of COVID-19

    14:40 Afternoon Break and Virtual Exhibit Hall Open

    15:10 Assessing Microbial Impact Using a Risk-Based Approach

    Hilary Chan

    Hilary Chan, MS Principal Quality Control Scientist, Takeda
    View Bio

    • What is Microbial Impact?
    • Use of risk-based tools to evaluate microbial impact
    • Considerations for mold and mycotoxin
    • Practical application – examples
     

    15:50 Live, Stressed, and Dead Microorganisms – Their Role in Microbial Test Method Validation

    Tony Cundell

    Tony Cundell, Principal Consultant, Microbiological Consulting, LLC
    View Bio

    • The effects of different stress factors, i.e., heat, starvation, growth phase, extreme pH, osmotic stress, antimicrobial agents, etc. on representative microorganisms
    • These stress factors will be related to manufacturing processes and drug product attributes; simulating these stresses with candidate study protocols
    • Emphasising the continuum from repairable cell damage, loss of cell viability to cellular death
    • Reviewing the role of repair mechanisms to damage to cell membrane function, enzymatic activity, protein synthesis and nucleic acids in terms of the recovery and enumeration of microorganisms using growth and non-growth methods
    • A case will be made that use of stressed microorganisms as challenge organisms in method validation, suitability testing and growth production testing is not necessary
     

    16:30 Chair's Closing Remarks and Close of Day One

    Lynne Ensor

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

    8:00 Registration & Coffee

    9:00 Chair's Opening Remarks

    Lynne Ensor

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

    9:10 A Risk Based Cleaning and Disinfection Program

    Jim Polarine Jr

    Jim Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
    View Bio

    • Addressing Cleaning and Disinfection as a critical component of a contamination control program during a pandemic.
    • Discussing current regulations, disinfectant and sterilant technologies, and operator safety in-depth.
    • Insight into global regulatory expectations: FDA, MHRA, ANVISA, ANMAT, HPRA, EMA, and ANSM
    • Assessing critical industry guidance documents: Annex I, USP 43 <1072>, PDA Technical Report #70
    • Best practices in designing an effective risk-based program and understanding current industry trends regarding cleaning and disinfection
    • Covering current industry FDA Warning Letters and FDA 483s
     

    9:50 Designing an Aseptic Process Simulation in the light of the new EU GMP Annex 1

    Maximilian Augustin

    Maximilian Augustin, Validation Project Manager, Roche Diagnostics Gmbh
    View Bio

    • The fundamentals of a robust Aseptic Process Simulation under Annex 1
    • Comparing the new Annex 1 to established guidelines and best practice (FDA, PIC/S): What is new? What has changed?
    • Detailed look at major implications on your intervention control strategy
     

    10:30 Morning Break and Virtual Exhibit Hall Open

    11:00 Common Issues in The Sterility Assurance Assessment

    John Arigo

    John Arigo, Division of Microbiology Assessment Director, FDA
    View Bio

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

    11:40 Cleaning Validation Maintenance Program

    Fred Ohsiek

    Fred Ohsiek, Senior Specialist, Cleaning Validation, Novo Nordisk
    View Bio

    • Avoiding industry routine monitoring program pitfalls
    • In-depth discussion on periodic review, CPV, and dated validation packages
    • Process control risk assessment scope and purpose
    • Case studies in the best practice in CPV risk assessment
     

    12:20 Networking Break and Virtual Exhibit Hall Open

    13:20 Automating Endotoxin water monitoring at Boehringer Ingelheim with Endosafe® Nexus™ – A business and validation perspective

    Johannes Oberdoerfer

    Johannes Oberdoerfer, Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
    View Bio

    • Build your business case to show the impact of automation in your lab
            o Why is an economic assessment necessary?
            o Definition of financial parameters for your business case
            o Case study: business case of water monitoring with Endosafe® Nexus™ at BI
    • Define your validation strategy
            o Match the technology to the right application: water monitoring
            o Validation approach for automated compendial methods
            o Case study: validation of water monitoring with Endosafe® Nexus™ at BI
    • The Endosafe® Nexus™ in routine 
            o The importance of monitoring your automated rapid microbiological method
            o A look at the operating performance of Endosafe® Nexus™ units installed at BI
            o Benefits and opportunities of Endosafe® Nexus™ from BI perspective

    14:00 Microbial monitoring of pharmaceutical grade water systems

    Lacey Batts

    Lacey Batts, QC Biochemist II, Novo Nordisk
    View Bio

    • Water collection: 
           o All the types of waters we test 
           o Classifications 
           o Locations (from beginning of process to end)
           o Selective medias (specifically which media is used for each type)
    • Characteristics
    • Common Organisms ID across the industry from each type (water, soil, etc.)
          o Importance of controls
          o Sampling timeline (daily, weekly, monthly)
    • USP/EP industry regulations (and any additional regulatory agencies)
          o Referencing relevant chapters
     

    14:40 Afternoon Break and Virtual Exhibit Hall Open

    15:10 Proactive water loop monitoring using online continuous Biofluorescent Particles Counter – how can it be made real?

    Joanny Salvas

    Joanny Salvas, Manager, PAT projects, Pfizer
    View Bio

    • Example of early investigative use
    • Data from online pilot
    • Data from offline testing (pre-validation work)
    • Proposal for implementation strategy
     

    15:50 Inspection do's and don'ts

    Kashyap Bhatt

    Kashyap Bhatt, Manager GPV Quality Operations, Takeda
    View Bio

  • 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
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    Lynne Ensor

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

    +

    FEATURED SPEAKERS

    Fred Ohsiek

    Fred Ohsiek

    Senior Specialist, Cleaning Validation, Novo Nordisk
    Hilary Chan

    Hilary Chan

    MS Principal Quality Control Scientist, Takeda
    Jim Polarine Jr

    Jim Polarine Jr

    Senior Global Technical Service Manager, Steris Corporation
    Joanny Salvas

    Joanny Salvas

    Manager, PAT projects, Pfizer
    Johannes Oberdoerfer

    Johannes Oberdoerfer

    Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
    Kashyap Bhatt

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Lacey Batts

    Lacey Batts

    QC Biochemist II, Novo Nordisk
    Laurie Boyd

    Laurie Boyd

    Senior Microbiologist/Team Leader, Alkermes, Inc.
    Lynne Ensor

    Lynne Ensor

    Vice President, RCS Head of Global Compliance, Parexel International
    Matts Ramstorp

    Matts Ramstorp

    Professor in Cleanroom Technology, BioTekPro AB
    Maximilian Augustin

    Maximilian Augustin

    Validation Project Manager, Roche Diagnostics Gmbh
    Qiao Bobo

    Qiao Bobo

    Division Director, FDA
    Rosemary Versteegen

    Rosemary Versteegen

    CEO, International Serum Industry Association
    Sean OBrien

    Sean OBrien

    QA Director, Contamination Control, Sanofi

    Don Singer

    Senior Microbiology Technical Consultant, North America, and USP Microbiology Committee Chair 2020-2025, Ecolab
    Don Singer

    Fred Ohsiek

    Senior Specialist, Cleaning Validation, Novo Nordisk
    Fred Ohsiek

    Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor 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

    MS 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 Jr

    Senior Global Technical Service Manager, Steris Corporation
    Jim Polarine Jr

    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 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.

    Joanny Salvas

    Manager, PAT projects, Pfizer
    Joanny Salvas

    Joanny Salvas has a bachelor’s degree in biotechnological engineering and a Master in Applied Sciences (Chemical engineering). She has been developing and implementing Process Analytical Technologies for more than 10 years at Pfizer, both in Solids and Sterile Injectable processes. Her background in process control, statistical analysis, multivariate data analysis and spectroscopy enabled her to support many successful implementations of advanced control strategies in the Pfizer network. She leads the Pfizer RMM steering team responsible for establishing the strategy, the evaluation and implementation of technologies as well as the development of future microbiology analytics.

    Johannes Oberdoerfer

    Lead Scientist, Rapid Microbiology Methods, Boehringer Ingelheim Pharma GmbH & Co. KG
    Johannes Oberdoerfer

    As Lead Scientist in the Microbiology Group at Boehringer Ingelheim Biberach, Johannes is responsible for the screening, selection and successful implementation of state-of-the-art technologies in the microbiology routine labs. His main task is to drive the transformation of the labs in terms of automation, innovation and digitalization.
    Johannes has worked across multiple disciplines along his career including Research and Development, Quality Control and Microbiology at Boehringer Ingelheim.
    Johannes holds a Bachelor’s Degree in Process Engineering Biopharmaceuticals by the University of Applied Sciences, Bingen, Germany.
     

    John Arigo

    Division of Microbiology Assessment Director, 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

    Kashyap Bhatt is an accomplished Quality Assurance and Regulatory Affairs professional with 8+ years of experience in the pharmaceutical and biotechnology industry. Kashyap has a thorough knowledge of Drug Development, Drug Substance, and Drug Product standards within a GMP/GLP facility. Kashyap has contributed to the creation and standardization of Good Documentation Practices (GDP) at both developing and mature manufacturing sites, and has used various techniques to train quality/manufacturing staff in appropriate methods to ensure product quality and inspection readiness. Kashyap has provided QA and decision-making support for Process Development (PD), Manufacturing, Quality Control (QC), Facilities & Engineering (F&E), and Validation teams. In terms of inspections, Kashyap has a thorough knowledge and ability to perform facility, department, vendor and for-cause inspections at all regulated facilities within biotech/pharma organizations.

    Lacey Batts

    QC Biochemist II, Novo Nordisk
    Lacey Batts

    As a Biochemist II (Microbiologist II) in QC at Novonordisk Pharmaceutical-Site Clayton, I work with the Cleaning Validation team (as well the Clean Utilities team) as the direct representative for all water testing. I aid in planning and preparation for all current and future cleaning validation activities. I am currently involved in several method transfers/validations along with routine testing within the department.
    I hold a Bachelor degree in Industrial Technology, with a concentration in Bioprocess Manufacturing (with a minor in Business Administration) from East Carolina University, as well as an Associates in Biotechnology. I have had the opportunity to expand my knowledge in many areas over the past twelve years. My career began in Chemistry and grew to include Manufacturing, Microbiology, Tissue Culture and Biochemistry.
     

    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.

    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.

    Matts Ramstorp

    Professor in Cleanroom Technology, BioTekPro AB
    Matts Ramstorp

    Matts Ramstorp has been working for more than 35 years with cleanliness and hygiene as a researcher, consultant, lecturer and educator. Matts has a Master of Science in Chemical Engineering, Technology, a PhD in Applied Biochemistry (Biotechnology) and became Professor in Contamination Control and Cleanroom technology at LTH, Lund University of Technology in 2002. Matts has also published several text books in the field of cleanroom technology.

    Maximilian Augustin

    Validation Project Manager, Roche Diagnostics Gmbh
    Maximilian Augustin

    Maximilian joined Roche Diagnostics GmbH (Pharma Division) as Qualification Engineer and Process Validation Manager in 2014. For more than 5 years, he is responsible for Media Fills/Aseptic Process Simulation. He is an expert for the validation of sterilisation processes, designing and assessing aseptic interventions and manufacturing processes in traditional clean rooms, RABS and isolators for sterile drug product manufacturing and has broad experience in the field of cleaning validation and process validation. Maximilian holds a master’s degree in Biology.

    Qiao Bobo

    Division Director, FDA
    Qiao Bobo

    Dr. Qiao Bobo joined FDA in 2010, and currently serves as a Commander (CDR) in the United States Public Health Service (USPHS) and as a Division Director in the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). She oversees the scientific review and quality evaluation of pharmaceutical manufacturing of sterile drugs. Prior to joining CDER, CDR Bobo served as a Branch Chief in the Division of Manufacturing and Product Quality (DMPQ), Center for Biologics Evaluation and Research (CBER), FDA, where she oversaw pre-license and pre-approval inspections and manufacturing assessment of vaccines, therapeutics, cell gene products and devices. She previously served as a reviewer, lead inspector and team lead in DMPQ. Prior to joining the FDA, CDR Bobo spent 12 years in the private sector, from small startup company to big pharma, drafting regulatory submissions, auditing CMOs, and ensuring CGMP compliance for vaccines, cell and gene therapy products and in vitro diagnostic products. CDR Bobo holds a Ph.D. degree in Cell and Molecular Biology from the University of Vermont.

    Rosemary Versteegen

    CEO, International Serum Industry Association
    Rosemary Versteegen

    Sean OBrien

    QA Director, Contamination Control, Sanofi
    Sean OBrien

    Sean O’Brien
    Quality Assurance Director, Contamination Control
    Sanofi

    Contamination Control Strategy for the Facility of the Future
     

    Sanofi is building a new facility in Framingham, dramatically smaller than its other facility in Massachusetts at 13,000 square feet. However, the facility will be running 24/7 with rotating shifts of a relatively few operators primarily concentrated on 1st shift. The processes will be closed with substantial use of single use technology. Most of the space of the facility will be grade D/CNC in air quality, with a small Grade C suite housing a Grade A Laminar Flow Hood for seed inoculation.

    Tony Cundell

    Principal Consultant, Microbiological Consulting, LLC
    Tony Cundell

    Dr. Tony Cundell consults with pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories, as a Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

    He is a member of the 2020-2025 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods.

    Tony Cundell chaired the PDA task force responsible for the 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In 2009, he co-edited the book Water Activity Applications in the Pharmaceutical Industry and contributed two chapters. He was co-chair of the PDA task force responsible for the 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to pharmaceutical science.

    Recently Tony Cundell co-authored Controls To Minimize Disruption of the Pharmaceutical Supply Chain During the Covid-19 Pandemic published in the July-August, 2020 issue of the PDA J. Pharm. Sci. & Technol.
     

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    USP Microbiology 2021 – Keeping Up with Standards
    Workshop

    USP Microbiology 2021 – Keeping Up with Standards

    Online Virtual Event
    27th April 2021
    Online Virtual Event , USA

    Quality Risk Management Tools for Contamination Control
    Workshop

    Quality Risk Management Tools for Contamination Control

    Online Virtual Event
    27th April 2021
    Online Virtual Event , USA

    VENUE

    Online Virtual Event

    Online Virtual Event , 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.
    HOTEL BOOKING FORM

    Exhibitors


    Microcoat

    Exhibitors
    http://www.microcoat.de

    Microcoat offers a wide range of individual and specialized services for pharmaceutical industry. In close cooperation with our customers, we aim for best performance building on a complete range of advanced technologies and uncompromised quality standards.

    Based on long lasting experience in endotoxin and pyrogen testing, Microcoat offers a set of methods (bacterial endotoxin testing and monocyte activation test) and skilled scientific personnel for investigation and resolving of low endotoxin recovery, non-routine projects and routine release measurements under GMP conditions. Services are run as flexible customer-specified projects including the search for root causes, exploration of realization alternatives, development of product-specific adaptions, and validation of newly established methods. We support customers in the selection and establishment of testing strategies for challenging samples and biopharmaceuticals in line with regulatory guidelines.


    Media Partners


    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.


    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

    Media Partners


    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


    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.


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    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


    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.


    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!


    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.


    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.


    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.


    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


    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.


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.

    SAVE TO


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

    Online Virtual Event

    Online Virtual Event
    USA

    Online Virtual Event

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SMi.
    Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out