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SMi is proud to announce the 4th Annual Pharmaceutical Microbiology East Coast Virtual 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.

  • DISCOVER case studies in CCS for the facility of the future and Aseptic Process Simulation design with Sanofi and Roche
  • UNCOVER the regulatory strategy weapon being used to battle the pandemic, and how manufacturing facility assessments are conducted during the COVID-19 Pandemic
  • EXPLORE the best practices in risk-based cleaning, disinfection, and microbial impact assessment, and join the panel discussion on new standards and regulatory compliance in light of the pandemic
  • DISCUSS the possibilities of continuous and automated endotoxin water monitoring with Pfizer and Boehringer Ingelheim
  • DIVE into the frequent issues with the Sterility Assurance Assessment with the FDA

 


 

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

All timings are in Eastern Daylight Time (BST-5)

9:00 Chairs' Opening Remarks

Lynne Ensor

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

Erika Pfeiler

Erika Pfeiler, Microbiologist, FDA
View Bio

9:10 Manufacturing facility assessments during COVID Pandemic

Qiao Bobo

Qiao Bobo, Division Director, Office of Pharmaceutical Quality, FDA/CDER
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 Break

    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 Monocyte Activation Test: Understanding and mitigating patient safety risks arising from the synergistic effects of mixed pyrogens

    Shabnam Solati

    Shabnam Solati, CEO & Co-Founder, CTL MAT LLC
    View Bio

    • Presenting the MAT as an in-vitro, human-specific, sensitive and reproducible pyrogen test;
    • Explaining its recent traction — that is, due to EP’s mandate to use MAT as NEP risk assessment for BET or replacement of RPT as stand-alone release assay;
    • Detailing what synergistic effects of mixed pyrogen are, their serious risks to patient safety, and MAT’s unique efficacy in their detection and quantification
     

    12:20 Cleanroom Operator Management

    Matts Ramstorp

    Matts Ramstorp, CEO and Founder, 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
     

    13:00 Networking Break

    14:00 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
     

    14:40 Serum Use Today – An Update

    Rosemary Versteegen

    Rosemary Versteegen, CEO, International Serum Industry Association
    View Bio

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

    15:20 Points to Consider: Demonstrating Comparability Between Recombinant and Lysate Reagents for BET Testing

    Karen McCullough

    Karen McCullough, Principal Consultant, MMI Associates, LLC
    View Bio

    • What is the definition of an alternative BET method?
    • What is the difference between method comparability and method suitability testing?
    • What is the role of the calibration standard in comparability testing?
     

    16:00 Afternoon Break

    16:30 Assessing Microbial Impact Using a Risk-Based Approach

    Hilary Chan

    Hilary Chan, 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
     

    17:10 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
     

    17:50 Chairs' Closing Remarks and Close of Day One

    Lynne Ensor

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

    Erika Pfeiler

    Erika Pfeiler, Microbiologist, FDA
    View Bio

    9:00 Chairs' Opening Remarks

    Lynne Ensor

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

    Erika Pfeiler

    Erika Pfeiler, Microbiologist, FDA
    View Bio

    9:10 A Risk Based Cleaning and Disinfection Program

    Jim Polarine Jr

    Jim Polarine Jr, Senior 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

    11:00 Common Issues in The Sterility Assurance Assessment

    John Arigo

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

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

    11:40 The Truth of Endotoxin Values – Points for Consideration During Investigation of Aberrant BET Results

    Johannes Reich

    Johannes Reich, Managing Director, Microcoat Biotechnologie GmbH
    View Bio

    • The nature of endotoxin
    • Methods for endotoxin detection
    • Case studies: Challenging test results from daily testing

    12:20 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
     

    13:00 Networking Break

    14:00 Panel Discussion: New standards and regulatory compliance in light of the pandemic

  • How coping with the pandemic has paved a way for future protocols
  • Successful remote manufacturing facility assessments and audits
  • Industry reactions to adversely affected supply chain and distribution
  • Viral Control Strategy: Masking, HVAC, and Operator controls
     
  • Jim Polarine Jr

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

    Lynne Ensor

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

    Kashyap Bhatt

    Kashyap Bhatt, Manager GPV Quality Operations, Takeda
    View Bio

    Don Singer

    Don Singer, Microbiology Expert Committee Chair, US Pharmacopoeia
    View Bio

    14:40 Automating Endotoxin water monitoring at Boehringer Ingelheim with Endosafe® Nexus™ – A business and validation perspective

    Johannes Oberdoerfer

    Johannes Oberdoerfer, 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

    15:20 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
     

    16:00 Afternoon Break

    16:30 Quality Risk Management Tools for Contamination Control

    • Background: the drawback of standard risk tools for contamination control
    • Executing the new holistic contamination control risk tool
    • Adapting the methodology of the holistic risk tool for other applications
    • Avoiding common risk management pitfalls

     

    Cheryl Essex

    Cheryl Essex, Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
    View Bio

    Jon Williams

    Jon Williams, Quality Risk Management , Sanofi-Aventis Deutschland GmbH
    View Bio

    17:10 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
  • 17:50 Chairs' Closing Remarks and Close of Day Two

    Lynne Ensor

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

    Erika Pfeiler

    Erika Pfeiler, Microbiologist, FDA
    View Bio

    +

    FEATURED SPEAKERS

    Cheryl Essex

    Cheryl Essex

    Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
    Don Singer

    Don Singer

    Microbiology Expert Committee Chair, US Pharmacopoeia
    Erika Pfeiler

    Erika Pfeiler

    Microbiologist, FDA
    Fred Ohsiek

    Fred Ohsiek

    Senior Specialist, Cleaning Validation, Novo Nordisk
    Hilary Chan

    Hilary Chan

    Principal Quality Control Scientist, Takeda
    Jim Polarine Jr

    Jim Polarine Jr

    Senior Technical Service Manager, Steris Corporation
    Joanny Salvas

    Joanny Salvas

    Manager, PAT projects, Pfizer
    Johannes Oberdoerfer

    Johannes Oberdoerfer

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

    Johannes Reich

    Managing Director, Microcoat Biotechnologie GmbH
    Jon Williams

    Jon Williams

    Quality Risk Management , Sanofi-Aventis Deutschland GmbH
    Karen McCullough

    Karen McCullough

    Principal Consultant, MMI Associates, LLC
    Kashyap Bhatt

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Lacey Batts

    Lacey Batts

    QC Biochemist II, QC Microbiology and Biochemistry, 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

    CEO and Founder, BioTekPro AB
    Maximilian Augustin

    Maximilian Augustin

    Validation Project Manager, Roche Diagnostics Gmbh
    Qiao Bobo

    Qiao Bobo

    Division Director, Office of Pharmaceutical Quality, FDA/CDER
    Rosemary Versteegen

    Rosemary Versteegen

    CEO, International Serum Industry Association
    Sean OBrien

    Sean OBrien

    QA Director, Contamination Control, Sanofi
    Shabnam Solati

    Shabnam Solati

    CEO & Co-Founder, CTL MAT LLC

    Cheryl Essex

    Head of Microbiological Control for Biologics, Sanofi-Aventis Deutschland GmbH
    Cheryl Essex

    Ms. Essex is the recognized global expert in Microbial Contamination Control for Sanofi. She lead the creation of a global standard on contamination control strategy as part of Sanofi’s Annex 1 implementation. Ms. Essex is also co-lead of the PDA author team for a new technical report on Contamination Control Strategy.
    Ms. Essex has 16 years’ experience in Contamination Control and Microbiological Quality Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human stem cell systems. Ms. Essex holds a BSc in Biology with Microbiology focus and two graduate degrees in Bioengineering. She has built strong technical expertise in all aspects of contamination control including facility, utility and process control, and equipment cleaning validation. She is also well versed in microbiological methodology and quality risk management.
    Full Bio:
    Ms. Essex is the recognized global expert in Microbial Contamination Control for Sanofi. She leads a committee of Microbial Control leaders from across the global Sanofi network. Ms. Essex also supports regulatory inspections and conducts investigations, risk assessments, internal audits and training in the area of Contamination Control for the Sanofi network.
    Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds two graduate degrees in Bioengineering. Over the past 16 years, she has held various positions in Contamination Control and Microbiological Quality Control at established biologics companies, biologics contract manufacturers, and emerging biotechnology working in mammalian, microbial and stem cell systems.
    Through the course of her career, Ms. Essex has built strong technical expertise in all aspects of contamination control including facility, utility and process control, and equipment cleaning validation. She is also well versed in microbiological methodology and quality risk management.
    Cheryl believes that good control requires a solid foundation of rules, but excellent control requires an understanding of principles applied with good judgment. For this reason, she puts a strong emphasis on awareness and education for front-line staff.
     

    Don Singer

    Microbiology Expert Committee Chair, US Pharmacopoeia
    Don 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.

    Erika Pfeiler

    Microbiologist, FDA
    Erika Pfeiler

    Dr. Erika Pfeiler is a microbiologist and Branch Chief in the FDA/CDER Division of Microbiology Assessment, where she performs and oversees microbiology reviews of ANDAs, NDAs, and INDs. She joined CDER in 2012. Her areas of particular interest in pharmaceutical microbiology include rapid microbiological testing methods, pharmacy compounding, and the microbiological aspects of nonsterile products. Dr. Pfeiler has an educational background in food microbiology, and received a B.S. from the University of Tennessee and a Ph.D. from North Carolina State University.

    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

    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 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, 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.

    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

    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.
     

    Johannes Reich

    Managing Director, Microcoat Biotechnologie GmbH
    Johannes Reich

    Dr. Johannes Reich is Managing Director at Microcoat Biotechnologies GmbH in Germany where he is responsible for Endotoxin and Pyrogen test services. Johannes actively engages with the regulatory and scientific community through participation in dedicated working groups, presentations as well as publications in peer-reviewed journals and he is internationally known for his expertise concerning the phenomenon of low endotoxin recovery. Johannes received his PhD in Chemistry from the University Regensburg in Germany.

    John Arigo

    Division of Microbiology Assessment Director, Office of Pharmaceutical Manufacturing Assessment, FDA/CDER
    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.

    Jon Williams

    Quality Risk Management , Sanofi-Aventis Deutschland GmbH
    Jon Williams

    Jon Williams is a member of the Sanofi Global Quality Risk Management (QRM) team tasked with designing, executing and growing the vision and strategy for QRM across the Sanofi manufacturing organization. The team creates harmonized practices targeted at anticipating and avoiding unacceptable risk based on ICH Q9 principles. Specifically, Jon supports manufacturing sites in the implementation and integration of QRM principles throughout the site quality organization including training on established risk tools (e.g. PHA, FMEA, HACCP) and the development of new tools.

    Karen McCullough

    Principal Consultant, MMI Associates, LLC
    Karen McCullough

    Karen Zink McCullough is owner and principal consultant at MMI Associates, LLC. Her interests include pharmaceutical microbiology and adapting Quality Systems to the challenges of cell and gene therapy manufacturing. She is acknowledged as an expert in the field of bacterial endotoxins testing, and has published and spoken widely on the subject. She is the editor and an author of the book, "The Bacterial Endotoxins Test: A Practical Guide"
    Ms McCullough is a member of the USP Expert Microbiology Committee, General Chapters and was founder of the LAL Users’ Group. Ms. McCullough received her BA in Bacteriology from Rutgers University and her MS in Molecular Biology from the University of Oregon.

    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, QC Microbiology and Biochemistry, 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

    CEO and Founder, 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, Office of Pharmaceutical Quality, FDA/CDER
    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 Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), FDA, where she oversaw pre-license and pre-approval inspections and manufacturing assessment of vaccines, therapeutics and in vitro diagnostics devices. She also served as a reviewer, lead inspector and team lead. 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 drugs, vaccines, cell and gene therapy products and devices. She is the recipient of numerous awards, including AMSUS Rising Star, Senior Scientist of the Year, VADM Richard Carmona Inspiration Awards and FDA Commissioner’s Special Citations. 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

    Rosemary Versteegen, PhD
    Chief Executive Officer
    International Serum Industry Association

    Dr Versteegen received her B.Sc. and Ph.D. degrees in Biochemistry from Glasgow University, Scotland. She held Postdoctoral scholarships at Cambridge University, England and the National Institutes of Health working in areas of disease research. Following several years in NIH sponsored cancer research programs, she joined Life Technologies and held various key roles, both technical and business oriented, including Vice President of the GIBCO Manufacturing Facility, Vice President of Regulatory Affairs, Vice President of New Business Development and Vice President of Strategic Planning. In 2000, Dr Versteegen became a founding partner of the Lifia Group, a consulting organization focused on helping life science and biotechnology companies grow through clearly enunciated, actionable strategic plans

    Since its inception in 2006, Dr Versteegen has been the CEO of the International Serum Industry Association, a global life science not-for-profit association. The mission of the Association is to establish, promote and assure compliance with uncompromised standards of excellence and ethics in the business practices of the global animal serum and animal derived products supply industry. The primary focus is on safety and safe use of serum and animal derived products through proper origin traceability, truth in labeling, and appropriate standardization and oversight.
     

    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.

    Shabnam Solati

    CEO & Co-Founder, CTL MAT LLC
    Shabnam Solati

    Shabnam Solati developed a Monocyte Activation Test to meet the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to building the future of MAT beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

    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.
     

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    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.
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    Preliminary Attendee List

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    UPDATED BROCHURE - SMi's 4th Annual Pharmaceutical Microbiology Virtual Conference 2021

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    Conference Report: Pharmaceutical Microbiology East Coast

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    Chair Interview - Lynne Ensor, Parexel

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    Speaker Interview - Johannes Oberdoerfer, Boehringer Ingelheim

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    Speaker Interview - Donald Singer, US Pharmacopoeia

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    Speaker Interview - Lacey Batts, Novo Nordisk

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    Speaker Interview - Laurie Boyd, Alkermes, Inc.

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    Speaker Interview - Joanny Salvas, Pfizer

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    Speaker Interview Tony Cundell, Microbiological Consulting, LLC

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    Pre-Conference Workshops - Pharmaceutical Microbiology East Coast

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    2-day program - Pharmaceutical Microbiology East Coast 2021

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    Past Attendee List for Pharmaceutical Microbiology East Coast

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    Past Speaker Presentation - Veronika Wills - Associates of Cape Cod

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    Past Speaker Presentation - Shabnam Solati - CTL-MAT

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    Past Speaker Presentation - Michael Song

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    Past Speaker Presentation - Scott Nichols - Kite Pharmaceuticals

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    Past Speaker Presentation - Maria Lopez Barragan - Barragán Bioconsulting

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    Past Speaker Presentation - Lynne Ensor - Parexel

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    Past Speaker Presentation - Jim Polarine - STERIS

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    Past Speaker Presentation - Lakyia Wimbish - LONZA

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    Past Speaker Presentation - Hilary Chan & Maria Dunnells - Takeda

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    Past Speaker Presentation - Diane Rasci - Parexel

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    Past Speaker Presentation - Brendan Tindall - bioMérieux

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    Sponsors


    bioMérieux

    Sponsors
    http://www.biomerieux-usa.com/biopharma

    bioMérieux, Inc. helps our clients unlock greater value from their organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. Clients benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.


    CTL-MAT

    Sponsors
    https://www.ctlmat.com/

    CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.


    Microcoat

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    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.


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    Medical Design Briefs

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    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.


    Rapid Microbiology.com

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    https://www.rapidmicrobiology.com

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


    Labcompare

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    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.


    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

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    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

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    Gate2Biotech

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    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.


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    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


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    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 Target Review

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    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.


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    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!


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    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


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    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.


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    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.


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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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