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SMi proudly presents the 3rd Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on the 5th and 6th of June 2019.
The pharmaceutical microbiology field is an ever-present constant in almost all areas of pharmaceuticals. We are experiencing a period of rapid change, with new regulatory considerations to implement into our environmental monitoring programmes,  new technologies to improve processes and novel validation techniques.

Join us as we delve into the current evolving issues facing this industry, such as: risk-based approaches to aseptic processing, methods of contamination prevention, creating risk-based environmental monitoring programmes, water monitoring and treatment.

Testimonials from our 2018 event:

"Great conference!"

"Very excellent agenda, speakers, setting! Keep growing this forum!"

"Overall , great conference! Love the variety!"

 

Join us this year and hear from industry experts in the field of pharmaceutical microbiology discuss how to overcome challenges when implementing rapid microbial methods; gain insight into the developments in creating an effective contamination control strategy that meets regulatory requirements; assess new methods in endotoxin testing; explore strategies towards determining what an effective EM program is and how compliance is ensured; and much more. Finally, learn from and benchmark with key opinion leaders in their respective fields within pharmaceutical microbiology through the two-day pre-conference workshops covering a holistic approach to contamination control and reviewing a roadmap to a holistic approach to microbial impurities, endotoxins, and LER.

Abbott Laboratories; Advanced Sterilization Products (J&J); Ajinomoto Althea, Inc.; Allergan; Althea; Amneal Pharmaceuticals; Associates of Cape Cod; Association of Cape Cod, Inc; AstraZeneca; Atara Biotherapeutics; Battelle Memorial Institute; Bayer Healthcare; Bimeda; Biofiredx; Biomerieux; bioMerieux Industry; Bioscience International; BioVectra Inc; BioVigilant Systems; Charles River; Charles River Laboratories; Fujifilm Wako Chemicals USA Corp; Genentech; Genentech Inc; Genentech, Inc; Gilead Sciences; Grifols Biologicals; Janssen; Lonza Walkersville, Inc.; Mettler Toledo; Microbiologics; Microrite Inc.; Microrite, Inc.; Millipore Sigma; Morphotek, Inc.; Mycoplasma Biosafety Services GmbH; Northstar Medical Radioisotopes; Novatek International; Pacira Pharmaceuticals Inc; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Revance Therapeutics; Roche; San Diego State University, Women in Science Society; Steris Corporation; Takeda Pharmaceutical Company Limited; Teva Pharmaceuticals; UCSD; Ultragenyx Pharmaceutical; University of California San Diego; University of New England; University of Veterinary Medicine Vienna; Vital Therapies; Xellia Pharmaceuticals;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Ziva Abraham

Ziva Abraham, CEO, Microrite, Inc.
View Bio

9:10 Contamination control in drug manufacturing

Lucia Clontz

Lucia Clontz, Quality Director, Xellia Pharmaceuticals
View Bio

  • Regulatory expectations for a contamination control strategy
  • Types and potential sources of microbial contamination
  • Best practices in management of microbial contamination, to include best practices in materials management, personnel training and gowning as well as equipment, process, and facility design.

     

  • 9:50 Pharmaceutical water treatment in a multi-product facility

    Matts Ramstorp

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

    10:30 Morning Coffee

    11:00 Cleanroom Garments from a Quality Risk Management Perspective

    Heidi Anderson

    Heidi Anderson, Principal Scientist, Microbiology, Abbott
    View Bio

    11:40 The Conundrum of Microbial Identification

    Bindhu Verghese

    Bindhu Verghese, R&D Sr Staff Scientist Microbial Solutions, Charles River Laboratories
    View Bio

    12:20 Networking Lunch

    13:20 Fungal Identification: Challenges and Pitfalls

    Veronika  Wills

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

    14:00 Low Endotoxin Recovery (LER)

    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche Diagnostics Gmbh
    View Bio

    14:40 Afternoon tea

    15:10 The Microbiology & Sterilization of Medical Devices

    Dan  B. Floyd

    Dan B. Floyd, MDM Specialist Microbiologist, AAMI Certified Industrial Sterilization Specialist, DuPont Protection Technologies

    15:50 Extended Q&A Session

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

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

    9:10 A risk-based approach to cleaning and disinfection

    Jim Polarine

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

  • Overview of EU, U.S. and global industry regulations for cleaning and disinfection
  • Annex-1, FDA warning letters, and 483’s expectations and considerations
  • Current antimicrobial products in the industry and creating a cleaning and disinfectant programme
  • Sterility relating to disinfectants and sporicides
  • 9:50 Investigating sterility failures

    Anita Bawa

    Anita Bawa, Quality Control Director, Bayer Healthcare
    View Bio

  • Current inspection trends
  • How to appropriately investigate sterility failures and determine entry point of contamination
  • Recommendations from the FDA for investigations
  • Case study
  • 10:30 Morning Coffee

    11:00 Sterile Compounding – Moving into the New Age

    Jason  McGuire

    Jason McGuire, Vice President, Global Quality, Fagron
    View Bio

     

    • Old School/New School – Review of progress for the industry
    • Production Trends toward Aseptic Control
    • FDA Enforcement focus
    • Future of 503B Outsourcing Facilities

    11:40 Just in time release of CAR-T Cell therapies

    Irving Ford

    Irving Ford, Head of CAR T QC Laboratories, Celgene Corporation
    View Bio

  • A patient centric approach for release of CAR-T Cell therapies
  • Overview of rapid sterility testing of CAR-T therapies
  • Overcoming challenges and scope for the future
  • 3 key lessons learned from a case study
     
  • 12:20 Networking Lunch

    13:20 Assessing Regulatory and Release Strategies in Live Bacterial Therapeutics

    Julie  Schwedock

    Julie Schwedock, Associate Scientific Fellow -New Modalities Development, Takeda Pharma Ceuticals International
    View Bio

  • The known regulatory landscape
  • Potentials for product interference with traditional assays and methods for assessing contamination
  • Environmental monitoring considerations
  • 14:00 Building a Holistic Business Case for Rapid Micro Methods

    Lisa Yan, PhD, RAC

    Lisa Yan, PhD, RAC, Scientist, Takeda Pharmaceutical
    View Bio

  • Challenges of RMM implementation and business case developments
  • Why should you consider a holistic business case?
  • How to best implement and build RMM strategy using a business case
  • Case study/strategy of how to approach a RMM business cases
  • 14:40 Afternoon Tea

    15:10 Rapid Microbial Methods - Reap benefits and avoiding pitfalls

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute
    View Bio

  • An overview of the design, validation and implementation of RMM.
  • Regulatory advice for RMM implementation
  • 3 key takeaways from a case study of RMM implementation
     
  • 15:50 Implementation of RMM into an effective EM programme

    Chris Knutsen

    Chris Knutsen, Associate Director, Microbiology, Bristol-Myers Squibb PRI

  • Overview of RMM uses in effective EM programmes
  • Overcoming issues of implementation
  • Ensuring compliance
  • Take away points from a recent case study
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Dan  B. Floyd

    Dan B. Floyd

    MDM Specialist Microbiologist, AAMI Certified Industrial Sterilization Specialist, DuPont Protection Technologies
    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode

    Senior Manager gASAT Microbiology, Global QC, Roche Diagnostics Gmbh
    Heidi Anderson

    Heidi Anderson

    Principal Scientist, Microbiology, Abbott
    Irving Ford

    Irving Ford

    Head of CAR T QC Laboratories, Celgene Corporation
    Jason  McGuire

    Jason McGuire

    Vice President, Global Quality, Fagron
    Julie  Schwedock

    Julie Schwedock

    Associate Scientific Fellow -New Modalities Development, Takeda Pharma Ceuticals International
    Lucia Clontz

    Lucia Clontz

    Quality Director, Xellia Pharmaceuticals
    Veronika  Wills

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod, Inc.
    Ziva Abraham

    Ziva Abraham

    CEO, Microrite, 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.

    Anita Bawa

    Quality Control Director, Bayer Healthcare
    Anita Bawa

    Anita has 20 years of experience in the biotechnology and blood bank industries. She has an excellent understanding of cell banking, manufacturing, and quality control testing. During her career, she has managed personnel and processes in various departments including microbiology, virology, biochemical manufacturing, and component & processing laboratories.

    In Blood Bank, she started as a Component Lab Technician and quickly moved to a managerial position and managing the processing and phenotype labs.

    In 1997, she transitioned to Genentech, where she started as a Fermentation Supervisor and managed the mammalian cell culture processes and facility environmental testing. Later she managed the E.coli and Cell Culture Fermentation plant and worked with Regulatory and Quality Assurance for routine and new product license inspections. She participated in internal and external audits and inspections. She managed QC functions and work with cross sites with QC related projects and method transfer.

    In 2012, she joined Bayer to manage the Microbiology and Virology groups, currently manages Quality Control Microbiology/Environmental Monitoring/Cell Biology/Virology departments and oversees the operations, method validation, microbial identification, and discrepancy groups. She is an active member of ASM, PDA, and PMF.

    Anita obtained her Bachelor of Marketing and Management degree from Saint Mary College and Master in Business Administration from the University of San Francisco.
     

    Bindhu Verghese

    R&D Sr Staff Scientist Microbial Solutions, Charles River Laboratories
    Bindhu Verghese

    Bindhu Verghese received her PhD in Biological Science from the University of Tulsa, Oklahoma in 2007. After three years of postdoctoral research work on the frontier areas of food and environmental microbiology at the Department of Food Science, Pennsylvania State University, University Park, PA, she joined as an R&D Senior Staff Scientist in Microbial Solutions at Charles River Laboratories (CRL) in Newark, DE. She has over 15 years of experience working with molecular & microbial techniques, microbial genomics, and bioinformatics. As a senior staff scientist at CRL, she is responsible for microbial library development as well as evaluating new technologies and coordinating research studies to meet business needs. She has successfully led numerous projects to develop, optimize, and implement microbial platforms. In addition, she has authored and co-authored numerous peer-reviewed microbiological journals and also presented her research at several national and international conferences.

    Chris Knutsen

    Associate Director, Microbiology, Bristol-Myers Squibb PRI
    Chris Knutsen

    Dan B. Floyd

    MDM Specialist Microbiologist, AAMI Certified Industrial Sterilization Specialist, DuPont Protection Technologies
    Dan  B. Floyd

    Friedrich von Wintzingerode

    Senior Manager gASAT Microbiology, Global QC, Roche Diagnostics Gmbh
    Friedrich von  Wintzingerode

    Friedrich is Senior Manager at Roche-Genentech Global Analytical Science and Technology, Global QC. He is Head of Roche-Genentech global Endotoxin Expert Group and Roche-Genentech global SME on microbial impurity contaminations and LER.
    After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany.
    He joined Roche in 2001 working as Micro lab Manager and Senior Manager on various topics (environmental monitoring, biochemical cleaning analytics, microbiological IPC and analytics for release, endotoxin testing, LER). Friedrich led several Roche-Genentech Micro expert teams (e.g. identification, microbiological testing) and co-chaired the PDA LER Task Force. He chaired and co-chaired several Endotoxins and Pyrogen Sessions at Pharmalab and PDA.
     

    Heidi Anderson

    Principal Scientist, Microbiology, Abbott
    Heidi Anderson

    Heidi Anderson is the Principal Scientist of Microbiology and Environmental Monitoring for Abbott Laboratories. After graduating from the University of Wisconsin with a degree in Medical Microbiology and Immunology she began her career with Abbott’s Diagnostics Division and has continued to work there for nearly 15 years.
     

    Heidi specializes in testing, facility design, risk management, aseptic techniques and gowning for non-sterile or microbially controlled manufacturers. She has extensive experience with FDA inspections of non-sterile production facilities.
     

    Heidi is originally from Twin Lakes, Wisconsin where her family owns an apple orchard. She currently lives in Burlington, Wisconsin with her husband, Steve and their twins, Quinn and Juniper.
     

    Irving Ford

    Head of CAR T QC Laboratories, Celgene Corporation
    Irving Ford

    Irving has over 28 years of QA/QC experience in pharmaceutical/biotechnology and cell/gene therapies industries.

    Prior to joining Celgene, Irving was a significant contributor for activities supporting the commercial approval of Novartis’ CAR T product Kymriah®.

    Irving is an active member of PDA and recently served on the committee for the 2018 Global Conference on Pharmaceutical Microbiology. Irving is also a co-author for PDA’s TR for EM of Low Bioburden Facilities.

    Currently, Irving is working on a task force for creating an ISO Standard for apheresis collection. Irving is also co-authoring a White Paper for appropriate microbiological controls for ATMPs manufacturing.
     

    Jason McGuire

    Vice President, Global Quality, Fagron
    Jason  McGuire

    Jason has spent 20 years in the health care field starting first in retail pharmacy and eventually moving to QA/QC. For the last 15 years, he has worked directly and indirectly with compounding and hospital pharmacies, medical device, herbal medicines and pharmaceutical companies. He is a microbiologist by education and expertise in addition to consulting for pharmaceutical and biotech companies helping them troubleshoot and bringing solutions to complex challenges. He has worked in increasing levels of management roles throughout his career and is now the Global Quality Director for Fagron, a leader in the personalized medicines field.

    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.

    Julie Schwedock

    Associate Scientific Fellow -New Modalities Development, Takeda Pharma Ceuticals International
    Julie  Schwedock

    Julie Schwedock, PhD is an Associate Scientific Fellow CMC, New Modalities Development at Takeda Pharmaceuticals where she works on the process and analytical development of Live Bacterial Products (LBPs) focused on treating dysbiosis of the gut microbiome. Prior to that she was Associate Director of Analytical Development and QC at Vedanta Biosciences, also working with LBPs, where she developed analytics in an uncertain regulatory landscape for a product now entering Ph2 clinical trials. She was the Director of Microbiology R&D at Rapid Micro Biosystems, Inc., a company whose mission is to develop rapid microbiological techniques for pharma and food microbiology. And she also worked as a Senior Scientist at Genomic Profiling Systems, a company whose mission was to develop rapid diagnostics for infectious disease. She received her Ph.D. from Stanford University, and her B.S. from MIT.

    Lisa Yan, PhD, RAC

    Scientist, Takeda Pharmaceutical
    Lisa Yan, PhD, RAC

    Lisa Yan, PhD, RAC is part of Takeda Pharmaceutical Company Limited supporting Global Microbiology, where she’s responsible for the global harmonization of microbiology methods, global quality compliance and contamination control strategies across the Takeda network. Lisa holds a regulatory affairs credential and is an active member in multiple microbiology work forums including OWBA (Online Water Bioburden Analyzer) and BPOG (BioPhorum Operating Group) with the goal of advancing rapid microbiological methods within the industry. She currently leads and hosts a rapid micro community of practice within the Takeda network. Prior to Takeda, Lisa has held various roles in quality assurance and QC microbiology at Shire PLC, Baxalta and Baxter. Lisa received her Bachelors of Science in Biochemistry at UCLA and Doctorate of Philosophy degree at USC Keck School of Medicine in HPV and Prostate Cancer Immunotherapy.

     

    Lucia Clontz

    Quality Director, Xellia Pharmaceuticals
    Lucia Clontz

    Lucia Clontz, D.H.Sc., M.S., works as Quality Director at Xellia Pharmaceuticals in Raleigh, NC, USA. She is also a Teaching Fellow at the Biomanufacturing Training and Education Center (BTEC) at the North Carolina State University, in Raleigh, NC. Dr. Clontz has more than 30 years of industry experience in quality, pharmaceutical microbiology, laboratory management, operational excellence initiatives, and training. Dr. Clontz is a published author, speaker, and workshop leader at both national and international conferences, and in 2004, she received the PDA's Distinguished Editor/Author award. Dr. Clontz is a member of the USP Pharmaceutical Waters Expert Panel (2010-2020) and co-author of the PDA Technical Report No 69, Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations. Dr. Clontz has Bachelor of Science degrees in Chemistry, with a minor in Chemical Engineering, and in Marine Sciences. She also holds a Master's degree in Microbial Biotechnology and a Doctorate in Health Sciences.

    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.

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod, Inc.
    Veronika  Wills

    Veronika Wills, has been with ACC Technical Services for over 10 years and in her current role as Assistant Manager of Technical Services, she leads the team of experts on all aspects of endotoxin and glucan testing, such as method development, troubleshooting, investigations, and low endotoxin recovery. Veronika is globally recognized as ACC’s technical expert and technical writer and frequently attends and speaks at scientific conferences, seminars and trainings. 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

    Ziva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
    Ziva has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi for her PhD degree. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
     

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Contamination Control: A Holistic Approach
    Workshop

    Contamination Control: A Holistic Approach

    Hyatt Regency Mission Bay
    4th June 2019
    San Diego, USA

    A holistic approach to microbial impurities, endotoxins and LER
    Workshop

    A holistic approach to microbial impurities, endotoxins and LER

    Hyatt Regency Mission Bay
    4th June 2019
    San Diego, USA

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    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

    Attendee List RELEASED as of 31st May 2019

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    Pharmaceutical Microbiology West Coast 2019 Brochure

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    Speaker interview with Matts Ramstorp, BioTekPro AB

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    Speaker interview with Friedrich von Wintzingerode, Roche Diagnostics Gmbh

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    Speaker interview with Anita Bawa, Bayer Healthcare

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    Microbiology West Coast Invite from the Chair - Ziva Abraham, Microrite

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    Speaker Biographies for Pharmaceutical Microbiology West Coast 2019

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    Past Speaker Presentation 2018 - DIAGNOSTICS ABBOTT

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    Past Speaker Presentation 2018 - Associates of Cape Cod

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    Past Speaker Presentation 2018 - MICRORITE

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    Past Speaker Presentation 2018 - ROCHE

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    Past Speaker Presentation 2018 from Charles River

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    Pharmaceutical Microbiology West Coast 2019 Conference Programe

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    Pharmaceutical Microbiology West Coast 2019 Workshops

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    Past Attendee List for Pharmaceutical Microbiology West Coast

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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.


    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

    Sponsors and Exhibitors
    http://www.PharmaProtection.DuPont.com

    DuPont™ Tyvek® is the proven choice for pharmaceutical protection and contamination control by leading pharmaceutical manufacturers around the world. With a unique balance of properties that cannot be found in any other material, Tyvek® provides trusted protection for the pharmaceutical industry as active packaging, final product packaging, sterile garments and cargo covers.


    Fujifilm Wako

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

    Long recognized as a world-renowned supplier of high purity chemicals, Fujifilm Wako has dedicated more than 30 years of research and development to providing innovative endotoxin-specific reagents and consumables for “every user and for every method”. Visit us at www.wakopyrostar.com to learn how Fujifilm Wako can best support your quality testing needs.


    Microbiologics

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

    At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.

    Media Partners


    Pharmaceutical-Review

    Official Media Partner
    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.


    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


    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.


    Rapid Micro Biosystems

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

    Rapid Micro Biosystems creates innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of healthcare products. The company’s Growth Direct™ - the first and only growth-based system to automate traditional microbial testing - detects contamination more quickly, delivering compelling economic benefits to manufacturers while improving their quality control (QC) process.


    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.

    Media Partners


    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.


    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.


    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


    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.


    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.


    evvnt Ltd

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    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    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


    Mednous

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    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmalicensing

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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.


    Biocompare

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    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.


    Pharmiweb

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    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.


    Colorado Bioscience

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    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.


    EIN News

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    Pharmavision

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    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


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    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.


    IBI - International Biopharmaceutical Industry

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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.


    Drug Discovery Today

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    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.


    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.


    Gate2Biotech

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    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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    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

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    Hyatt Regency Mission Bay

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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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    Contact SMi GROUP LTD

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