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SMi’s 2nd Annual Conference
Pharmaceutical Microbiology East Coast
April 10th – 11th, 2019 | Boston, USA
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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 industry experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss the revision of Annex 1, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring and gain insight into an industry perspective on automated endotoxin testing and process automation.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

9:10 Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Jim Polarine

Jim Polarine, Senior Technical Service Manager, STERIS Corporation
View Bio

• Effective ways to validate disinfectants, sanitizers, and sporicides
• The most common causes for coupon testing failures
• The most current industry methods for conducting coupon testing
• Developing risk assessments for choosing environmental isolates and coupon surfaces
• Current global regulatory guidance on disinfectant validation
 

9:50 Environmental monitoring in barrier separation technology: Isolators and RABS

James  Drinkwater

James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

• Environmental classification, microbiological qualification and monitoring of Filling lines with barrier technology considering new GMP regulations.
• Contamination control strategies, risk identification and risk assessment to define EM sampling positions and sampling frequency program.
• Rapid micro methods applied to barrier technology; challenges and new novel approaches
 

10:30 Morning Coffee

11:00 Microbiological Methods: Science and Regulation

David Hussong

David Hussong, Former Associate Director for New Drug Microbiology, FDA
View Bio

• Methods evolution
• Detection Methods
• Counting Methods
• Identification Methods
• Standards and Regulation
 

11:40 Regulations of Endotoxin detection methods: Follow the sample through the process

Veronika Wills

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

  • Prerequisites for in-house testing
  • Qualifications
  • Sampling and sample management
  • Suitability testing
  • Routine Testing, Trending and OOS
     
  • 12:20 What should a biotechnology company know about microbiology?

    Tony Cundell

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

    • Emerging biopharmaceutical companies responsible for a high percentage of biopharmaceutical product launches
    • Challenges for emerging biotechnology companies in taking products through discovery to the market place
    • Lack of microbiological expertise and dependence on CRO’s to provide these essential services
    • Overview of the areas of microbiology that are critical in the development of product dependent on recombinant DNA technologies, cell and gene therapies, RNA interference and human microbiome modification
    • Emphasis on clinical trial phase-appropriate solutions
     

    13:00 Networking Lunch

    14:00 Using an alternative gene sequence for species-level identification for closely related organisms

    Sunhee Hong

    Sunhee Hong, Senior. Staff Scientist, Charles River

  • An overview of closely related organisms
  • The closely related organisms that are frequently recovered from environmental monitoring programs in the pharmaceutical industry
  • Necessity of using alternative gene sequences for species-level identification in the pharmaceutical industry.
  • Evaluation of alternative gene sequence for species-level resolution in Burkholderia cepacia complex (BCC) and Bacillus cereus group (BCG).

     

  • 14:40 Development of a standadized risk assessment tool to enable a harmonized approach for environmental monitoring in pharmaceutical industry

    Hilary Chan

    Hilary Chan, Principal QC Scientist, Takeda (Shire)
    View Bio

    • BioPhorum-led industry collaboration on a standardized EM sampling risk assessment tool (RA) for cleanrooms, conventional aseptic filling lines, RABS, and isolators
    • Improved justification for EM sampling and identification of highest risk sample locations
    • Standardized approach for industry, improved confidence in application of objectively estimated risks
     

    15:20 Afternoon Tea

    15:50 Environmental monitoring and critical utility trending

    Steven A. Wieczorek

    Steven A. Wieczorek, Associate Director, Quality Control Microbiology, Sanofi
    View Bio

    • Trending Expectations and Best Practices
    • Trends Below Limits “The Proactive Approach” 
    • Cross Functional Team Data Analysis
    • Understanding Impact to Environment, Utility and Process
     

    16:30 Signal Intensity – An Integrated Approach to EM Data Trending

    Austin Kuo

    Austin Kuo, Principal Research Scientist, Sterility Assurance, Eli Lilly And Company
    View Bio

    • The challenges of interpreting and trending environmental monitoring  (EM) data
    • Overcoming the limitations of microbiological data generated via traditional culturing methodologies
    • Holistic analysis and trending of EM data utilizing a novel integrated approach
     

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    James  Drinkwater

    James Drinkwater, Chairman, Pharmaceutical and Healthcare Sciences Society

    9:10 Rapid microbial methods – a case study of implementation

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute
    View Bio

  •  The implementation of rapid methods in practice, how best to adopt these new methods and keep up with developments
  •  Validating the methods and conforming to regulatory requirements
  •  The issues surrounding the implementation of rapid methods and how to overcome them
  • How to best tailor your implementation proposal in terms of validation of your rapid method 
  • 9:50 Industry perspective on automated endotoxin testing and process automation

    Clyde Schultz

    Clyde Schultz, Global Director, Celgene
    View Bio

    • Streamlining QC testing through automated endotoxin testing
    • Advantages and disadvantages of automation
    • New technologies for automated endotoxin testing and process automation
    • Ensuring compliance with regulatory requirements

    10:30 Morning Coffee

    11:00 Cleanroom Garments from a Quality Risk Management Perspective

    Matts Ramstorp

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

    Cleanroom garments, including gloves, have since the beginning of the contamination control period been considered the primary barrier, minimizing particles derived from humans to contaminate the surrounding environment. The development of textile materials and garments have, however, not been highly prioritised during the last 20 years. Furthermore, much of the risk assessment and validation have to a great extent been submitted to the laundry and/or rental companies. The draft Annex 1 (Eudralex, volume 4) is indicating a totally different view in this regard, which will have an enormous impact on the end-user.

    · Historical background
    · The 2008 version of Annex 1 versus the 2017 draft
    · Quality Risk Management (QRM) – Cleanroom garments
    · Does the end user of cleanroom garments know what they are using and why?
    · How to formulate a URS (User Requirement Specification) on a cleanroom garment system

    11:40 Sterility Assurance Risk Management

    Sterility is one of the most critical quality attributes that all parenteral products must possess; yet, it is one of the most difficult to consistently and convincingly demonstrate to regulators.  This presentation discusses an
    • Demonstrating sterility towards regulators
    • Integrated, cross-functional strategy implemented at Eli Lilly and Company’s parenteral manufacturing facility in Indianapolis
    • Evaluate and mitigate risk associated with the manufacturing process and environment
     

    Frederic Ayers

    Frederic Ayers, Consultant Scientist, Eli Lilly And Company

    12:20 Networking Lunch

    13:20 Case study of environmental mold isolation in a controlled manufacturing facility

    Leslie Falco

    Leslie Falco, Microbial Control Strategist , Pfizer Inc

  • Area awareness and detection of atypical, low level recovery in a controlled environment
  • Response to atypical, low level recovery in a controlled environment
  • Manufacturing during atypical recovery in a controlled environment
     
  • 14:00 Combining Genetics with Traditional Methods for Microbial ID

    Jarrod Murphy

    Jarrod Murphy, Supervisor, Genentech
    View Bio

    • Summary of the Genetic Analysis Technology
    • Bacterial ID vs Fungi ID
    • Exceptions to the rules
    • Traditional methods (Back to the basics case studies)

     

    14:40 Risk Assessment of Traditional Culture-Based Microbiological Tests Requiring Contemporaneous Verification

    Hilary Chan

    Hilary Chan, Principal QC Scientist, Takeda (Shire)
    View Bio

    • BioPhorum-led industry perspective on ensuring data integrity of traditional microbiological culture-based test data
    • Fundamentals of ensuring microbiological test data integrity; effective sampling, valid testing and appropriate result reading and interpretation
    • Qualitative risk assessment for the traditional culture-based QC microbiological tests requiring contemporaneous verification by the second person.
     

    15:20 Afternoon Tea

    15:50 Ensuring Mycoplasma Safety of Cell-based Medicinal Products: Risk Assessments as Important Basis for Implementing PCR-based Batch Release Testing

    Renate Rosengarten

    Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
    View Bio

  • Features of mycoplasmas with respect to their contamination potential
  • Risk evaluation of the manufacturing process regarding mycoplasma entry and subsequent growth
  • Suitability assessment of PCR-based rapid mycoplasma detection methods for excluding false-positive and false-negative results
  • Choosing the right detection method and an appropriate validation design for batch release testing
  • 16:30 Management of risk in the use of animal sera

    Rosemary Versteegen

    Rosemary Versteegen, CEO, International Serum Industry Association
    View Bio

  • Certification of processes
  • Testing for geographic testing
  • Everything you need to know about Gamma Irradiation
  • 17:10 Chairman’s Closing Remarks and Close of Day Two

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    FEATURED SPEAKERS

    Andrew Bartko

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Clyde Schultz

    Clyde Schultz

    Global Director, Celgene
    David Hussong

    David Hussong

    Former Associate Director for New Drug Microbiology, FDA
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Leslie Falco

    Leslie Falco

    Microbial Control Strategist , Pfizer Inc

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Andrew Bartko

    Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. His graduate work consisted of deciphering spatially heterogeneous relaxation dynamics of glass forming systems using novel rotational single molecule microscopy techniques. In 2002, Dr. Bartko joined the Softmatter Nanotechnology and Advanced Spectroscopy Team at Los Alamos National Laboratory where he studied the ultrafast photophysics of semiconducting quantum dots. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. He now leads Battelle’s Rapid, Enumerated, Bioidentification System development program.

    Austin Kuo

    Principal Research Scientist, Sterility Assurance, Eli Lilly And Company
    Austin Kuo

    Mr. Kuo brings over 16 years of experience in parenteral manufacturing, with a focus on sterility assurance and environmental monitoring programs. He has led Quality and Technical Services organizations supporting environmental monitoring, aseptic process simulations (media fills), aseptic technique, personnel gowning and hygiene, aseptic interventions, sterile filtration validation, sanitization programs and agent validation, and sterility assurance risk assessments supporting parenteral operations.

    Clyde Schultz

    Global Director, Celgene
    Clyde Schultz

    I have worked in the United States Government, academia, and private industry for about 40 years. I hold a Ph.D. in microbiology and have been affiliated with The University of Calgary since 1996. For the last 10 years I have been a Director in the Quality Operations Department of Celgene. I have experience in solid oral product manufacture and testing, API production and testing and Drug Product manufacture and testing. I also have extensive experience in drug product delivery devices especially as they relate to the ocular environment.

    David Hussong

    Former Associate Director for New Drug Microbiology, FDA
    David Hussong

    David Hussong is the Chief Technical Officer at Eagle Analytical Services (Houston, TX). In addition, David is the chair of the USP Microbiology Expert Committee for the 2015 – 2020 cycle.

    In 2014, David retired after 30 years with the Food and Drug Administration (FDA). David earned his Ph.D. in microbiology from the University of Maryland at College Park (UMCP). He also was a research microbiologist at UMCP, the US Department of Agriculture and the US Naval Medical Research Institute.
     

    Frederic Ayers

    Consultant Scientist, Eli Lilly And Company
    Frederic Ayers

    Hilary Chan

    Principal QC Scientist, Takeda (Shire)
    Hilary Chan

    Hilary Chan is a Principal Quality Control Scientist in Global Microbiology at Takeda (Shire) 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 (Shire)’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead. Hilary has over 18 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.

    James Drinkwater

    Chairman, Pharmaceutical and Healthcare Sciences Society
    James  Drinkwater

    James Drinkwater

    Chairman, Pharmaceutical and Healthcare Sciences Society
    James  Drinkwater

    Jarrod Murphy

    Supervisor, Genentech
    Jarrod Murphy

    Jarrod Murphy has worked the past 17 years at Genentech and is currently a Supervisor overseeing the daily operations of the Quality Control Microbiology lab. He has extensive experience in Disinfectant Efficacy Testing, Product Bioburden Method Suitability Testing, Growth Promotion, Biological Indicators and values Servant Leadership, Lean initiatives and efficiencies. Mr. Murphy graduated from the University of California at Davis with a B.S. in Medical Microbiology and holds a Master’s of Business Administration with an emphasis in Finance from California State University Sacramento. He is most recently a guest lecturer at UC Davis and has previously worked in biotechnology research and development.

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Jim Polarine

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for eighteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. 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 as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches the cleaning and disinfection course module at the PDA Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is currently President Elect for the PDA Missouri Valley 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.

    Leslie Falco

    Microbial Control Strategist , Pfizer Inc
    Leslie Falco

    Matts Ramstorp

    Professor in Cleanroom Technology, BioTekPro AB
    Matts Ramstorp

    Matts Ramstorp has been working for more than 30 years with cleanliness and hygiene as a researcher, consultant, and educator. Matts is a Master of Science in Chemical Engineering, Technology Doctor of Applied Biochemistry (Biotechnology) and Professor of Renewable Engineering and Production Hygiene at LTH, Lund University of Technology. Matts has also published a number of books in the field of cleanroom technology.

    Renate Rosengarten

    Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
    Renate Rosengarten

    Prof Renate Rosengarten’s career originated from science and research through her work in academia which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she is Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria.
    Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has long-standing entrepreneur and business experience in the biotech area. She was the Founder and Managing Director of the previous niche market leader Mycosafe Diagnostics which she has in 2014 re-established under the company name Mycoplasma Biosafety Services. Prof Rosengarten started the company in 2004 as a university spin-off and built it from scratch to a technological innovation leader in the area of Industrial and Pharmaceutical Mycoplasmology.
    In addition to her management and business activities and her academic duties as a lecturer, reviewer, committee and advisory board member, Prof Rosengarten also serves as an independent mycoplasma expert, key opinion leader and consultant for biopharma and biotech companies under her own international brand Mycosafe®.
     

    Rosemary Versteegen

    CEO, International Serum Industry Association
    Rosemary Versteegen

    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.
     

    Shahram Lavasani

    CEO, ImmuneBiotech AB
    Shahram Lavasani

    Shahram Lavasani holds a PhD degree from Lund University (Sweden), in Medical Inflammation Research where he studied the immunoregulation and novel immunotherapies in multiple sclerosis (MS). He is a skillful immunologist with many years of research expertise on gastrointestinal complications in chronic inflammatory diseases. Focusing on Gut-Brain axis he has pioneered research in MS by demonstrating increased intestinal permeability and design of therapies targeting the gut microbiota. He is the founder of ImmuneBiotech, developed a proprietary lactobacilli library and established careful and multiple selection methods to screen and design formulations for the optimal therapeutic management of the diseases.

    Steven A. Wieczorek

    Associate Director, Quality Control Microbiology, Sanofi
    Steven A. Wieczorek

    Steven Wieczorek has nearly 20 years of Biotech Industry Experience in Quality Control Microbiology and Quality Assurance Contamination Control. Steven currently works at Sanofi Therapeutics and is the Associate Director of Quality Control Microbiology. As Head Chair of the Environmental Action Committee Steven has Trended and Assessed Environmental Monitoring and Critical Utility Data ensuring early detection of emerging trends and immediate implementation of remediation activities ensuring patient and product safety, reduced risk of contamination events and product loss.

    Sunhee Hong

    Senior. Staff Scientist, Charles River
    Sunhee Hong

    Tony Cundell

    Principal Consultant, Microbiological Consulting, LLC
    Tony Cundell

    Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and dietary supplement companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell 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 2015-2020 U.S.P. Microbiology Committee of Experts where he takes a leadership role in the area of modern microbiology methods, co-chairing the USP Expert Panel that published a stimuli article in the Sept-Oct. 2017 Pharmacopeial Forum entitled The Development of Compendial Rapid Sterility Tests.

    Tony Cundell chaired the PDA task force responsible for the ground-breaking 2000 Technical Report No. 33 The Development, Validation, and Implementation of New (Rapid) Microbiological Methods. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report No. 67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. He received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science. More recently Tony Cundell co-authored a review article entitled Data Integrity in the Microbial Testing in the September-October, 2017 issue of American Pharmaceutical Review.
     

    Veronika Wills

    Associate Manager of Technical Services, Associates of Cape Cod
    Veronika Wills

    Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

    Ziva Abraham

    CEO, Microrite, Inc.
    Ziva Abraham

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Mold Contamination Challenges
    Workshop

    Mold Contamination Challenges

    Battery Wharf Hotel
    12th April 2019
    Boston, USA

    VENUE

    Battery Wharf Hotel

    3 Battery Wharf, Boston, MA, 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

    UPDATED 2019 Attendees List for Pharma Microbiology East Coast

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    Chair Letter for Pharmaceutical Microbiology East Coast 2019

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    10 reasons to join the confex

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    2019 Speaker Interview with Cheryl Essex, Sanofi

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    2019 Sepaker Interview with Matts Ramstorp, BioTekPro AB

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    2019 Speaker Interview with Hilary Chan, Takeda

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    Pharmaceutical Microbiology East Coast 2019 - conference brochure

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    DUPONT CLEANROOM CLEANING AND DISINFECTION WHITEPAPER

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    DUPONT CONTROLLED ENVIRONMENTS - STUDY

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    Pharmaceutical Microbiology East Coast 2019 - 2-day program

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    James Drinkwater Chair Invite

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    Pharmaceutical Microbiology East Coast 2019 - Workshops

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    Pharmaceutical Microbiology East Coast 2019 - Full Programme

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    Pharmaceutical Microbiology East Coast - Past Attendee List

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    2018 Past Speaker Presentation - Battelle

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    2018 Past Speaker Presentation - Johnson & Johnson

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    2018 Past Speaker Presentation - ROCHE

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    2018 Past Speaker Presentation - Charles River

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    Sponsors and Exhibitors


    Associates of Cape Cod

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

    Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1?3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    bioMérieux

    Sponsors and Exhibitors
    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.


    Bioscience International

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

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


    BioVigilant

    Sponsors and Exhibitors
    http://www.biovigilant.com

    BioVigilant Instantaneous Microbial Detection™ instruments provide continuous, real-time results for monitoring of air and water. IMD® instruments determine particle size and biological status…simultaneously. No sample preparation or growth required. Visit with us to learn more about protecting your bottom line from the disastrous effects of microbial contamination.


    Charles River

    Sponsors and Exhibitors
    http://www.criver.com/microbialsolutions

    For over 30 years, Charles River has helped customers bring products to market safely and efficiently with revolutionary technologies and exceptional services that have changed the way we conduct microbial quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification, Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any single provider.


    DuPont Personal Protection

    Sponsors and Exhibitors
    http://www.dupont.com/products-and-services/personal-protective-equipment/controlled-environments-apparel-accessories.html

    For a wide range of industries, processes must be kept clean and uncontaminated. DuPont materials are used to create a variety of clothing for these controlled environments with different levels of comfort, durability, breathability, and protection in a variety of styles, including coveralls, lab coats, gowns, hoods and booties.


    InnovaPrep

    Sponsors and Exhibitors
    http://www.innovaprep.com

    InnovaPrep’s CP Select™ concentrates bacteria, molds, fungal spores, and viruses, including mycoplasma from liquid samples in minutes without incubation or centrifugation. Useful for both RMMs or culture assays. It is an essential tool for improving detection of trace biological and particulate contamination in environmental samples, water, culture media, parenteral fluids, and compounded drugs.


    METTLER TOLEDO

    Sponsors and Exhibitors
    http://www.mt.com

    METTLER TOLEDO Thornton has a long history of delivering real time, continuous measurement products specifically designed for regulated pharmaceutical water systems such as Conductivity, TOC, and Ozone. The 7000RMS Real time Microbial System instantly detects microbial (bioburden) presence enabling increased sensitivity, better process control, improved product quality, and reduced risk.


    University Of Guelph

    Sponsors and Exhibitors
    http://www.AFLuoguelph.ca

    University of Guelph, Laboratory Services Division, provides multifaceted analytical services within ISO/IEC 17025 accredited facilities. With scientific expertise and many years of experience in microbial ID, the lab provides culture and rapid gene-based services to the pharmaceutical industry to accurately identify and track bacteria, fungi and yeast from environmental monitoring programs.

    Media Partners


    Rapid Microbiology.com

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

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


    European Pharmaceutical Review

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

    European Pharmaceutical Contractor (EPC) is a quarterly publication dedicated to the international pharmaceutical contract market. Since its establishment in 1997, EPC has provided coverage of technical, strategic and regulatory developments within the industry. The magazine features in-depth opinion-led articles, reviews and interviews, on topics including drug development, outsourcing, pharmacovigilance, partnerships and eClinical management. Read EPC in print, online, or via the Samedan app.


    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


    Microbiology Society

    Official Media Partner
    http://www.microbiologysociety.org

    The Microbiology Society is a membership charity for scientists interested in microbes, their effects and their practical uses. It is one of the largest microbiology societies in Europe with a worldwide membership based in universities, industry, hospitals, research institutes and schools. Our members have a unique depth and breadth of knowledge about the discipline. The Society’s role is to help unlock and harness the potential of that knowledge.


    Genetic Engineering News

    Official Media Partner
    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

    Media Partners


    Pharmaceutical-Review

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

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


    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


    Journal for Clinical Studies

    Supporters
    http://www.jforcs.com

    JCS – Journal for Clinical Studies is peer reviewed. Supported by a team of industry experts, JCS brings you contemporary and authoritative articles which will guide the industry in the best practice in regulatory issues, market analysis, drug discovery, development, drug design, clinical research, data analysis, safety and efficacy, recruitment and retention, laboratories, analytical testing, custom and contract manufacturing, primary and secondary packaging and logistics and supply chain management.


    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.


    IBI - International Biopharmaceutical Industry

    Supporters
    http://www.biopharmaceuticalmedia.com

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


    Drug 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.


    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.


    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.


    Biocompare

    Supporters
    http://www.biocompare.com

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


    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!


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    pharmanews hq

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

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


    IPI

    Supporters
    http://www.ipimediaworld.com

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


    Technology Networks

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

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


    Contract Biotechnology

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

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. We are an online R&D matching tool that connects Scientifics and organizations involved in discovery, development and delivery of new healthcare products with service and products providers worldwide. Life science information technology is undergoing a revolution. Part of that revolution involves new, unexplored business models, open innovation, open data and collaboration. If you have a project or idea that you would like to propose, develop or run, we can help. A New Collaboration Network Model for Discovery Research and Development • Effective Platform: the 95% • 5.000 registered users // > 15.000 Newsletter subscribers • Geographical background: 45,5% Europe / 37,5% North America / 16,5% Asia / 0,5% ROW • Professional background: Outsourcing Manager, Project Manager, CEO, Business Developer, CSO, Account Manager, Sales & Marketing People, Scientists, R&D. For further information, please visit our website www.contract-biotechnology.com


    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.


    Farmavita

    Supporters
    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.

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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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