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SMi’s 4th Annual Conference
Pharmaceutical Microbiology West Coast
June 17th – 18th, 2021 | San Diego, 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, revised industry regulation, enhanced knowledge of innovative therapies, novel testing methods, this industry is ever expanding.
Join industry experts to discuss the latest topics and pressing challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations and approaches for conventional and rapid microbiology methods, discuss optimised environmental monitoring to best control contamination and gain insight into an industry perspective on alternative endotoxin testing methods and process automation, all contributing to better management of contamination in biopharmaceutical manufacturing.
 

Benefits:
LISTEN to the latest regulatory updates in the pharmaceutical microbiology industry from leading regulatory bodies
DISCUSS case studies from leading pharmaceutical companies revolutionizing the industry
EXPLORE advances in ATMP facility design and contamination control from emerging and established pharmaceutical and biopharmaceutical companies
DISCOVER the future of contamination control through a look at the advent of automated systems, continuous manufacturing and monitoring and reduced intervention from leaders in industry
 

• Senior Microbiologist
• Lead Scientist
• Laboratory Manager
• QA Specialist
• Drug Substance External Manufacturer
• QC Scientists
• Heads of Quality
• Business Development Manager
• Pharmaceutical Microbiology Consultant
• Higher Pharmacopoeial Scientist
• Analytical Standards Specialist
 

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; QuVa Phama; 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

James Polarine Jr

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

9:10 Building a Global Contamination Control Program

Lynn Johnson

Lynn Johnson, Scientist, Takeda
View Bio

  • Creating the global framework
  • Network implementation, emphasizing the collaboration between global and site partners
  • Embedding sustainability and continuous improvement into the program
  • Sharing lessons learned and best practices
  • 9:50 Cleanroom Pass Through Best Practices

    James Polarine Jr

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

  • Utilizing Sanitizers for Pass Thru Decon
  • Compelling New Data with a Sporicide followed by a Sanitizer
  • Controlling fungal and bacterial spores in Cleanrooms
  • 10:30 Morning Coffee

    11:00 Non-viable particle monitoring: Myths, mistakes and consequences

    Morgan  Polen

    Morgan Polen, Contamination Control and Cleanroom Expert, Microrite, Inc.
    View Bio

  • Common errors make in choosing particle monitoring devices
  • Standards and regulations related to particle monitoring
  • A glimpse into macro particle descriptor-why 5 micron particles are important
  • Mistakes made during particle monitoring-volume vs particles
  • When do particle monitoring devices become a source of contamination
  • 11:40 Paper Based Compliance versus Factual Contamination Control

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

  • Case studies related 483 observations and warning letters resulting from paper based compliance mindset
  • Level of risk appetite and risk tolerance by management; common reasons and consequences
  • Reasons why paper-based compliance fails
  • Lack or loss of knowledge base a common problem
  • Group exercise on paper-based compliance vs factual science-based risk assessment
  • 12:20 Networking Lunch

    13:20 ALL-WOMEN PANEL DISCUSSION: ‘Culturing’ Successful Women Microbiologists

  • Supplementing Your Microbiology Education and Training: Additional Resources for Microbiology Careers in Industry
  • Optimally Highlighting Your Pharmaceutical Microbiology Experience
  • Microbiology Careers Providing Balance of Work and Personal Life
  • Building Your Own Colony: Microbiology Networking for Success
  • Expanding Beyond a Microbiology-centric Focus: Recognizing Signals for Change
  • Lynne Ensor

    Lynne Ensor, Vice President, Technical, Parexel International
    View Bio

    Geeta Singh

    Geeta Singh, Technical Specialist III, Genentech
    View Bio

    Ziva Abraham

    Ziva Abraham, CEO, Microrite, Inc.
    View Bio

    Lynn Johnson

    Lynn Johnson, Scientist, Takeda
    View Bio

    Carol Davis

    Carol Davis, Manager QC Microbiology and Biology, Grifols, Inc
    View Bio

    14:20 One-Hour Mycoplasma Testing by Anyone, Anywhere, Anytime

    Sylvanie Cassard Guilloux

    Sylvanie Cassard Guilloux, Global Solution Manager, BioMerieux
    View Bio

    15:00 Mycoplasma Reference Standards for Implementing NAT-Based Mycoplasma Safety Testing of 'Classical Biopharmaceuticals' and ATMPs

    Renate Rosengarten

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

  • Pharmacopoeia mycoplasma reference strains according to EP 2.6.7. and JP 17th Ed. for use as reference standards in generic and product-specific validation of NAT methods for implementing in-process and batch release testing
  • Product relevance of mycoplasma reference strains for 'classical biopharmaceuticals' and ATMPs
  • Case studies: Selection of the required regulatory mandatory and product-relevant mycoplasma reference strains to be included as test organisms for implementing NAT-based mycoplasma safety testing of a given product according to the required product-relevant mycoplasma species spectrum coverage as determined by a risk assessment to ensure the suitability of the NAT method applied
  • Culture versus DNA reference standards
  • Acceptance criteria for viable and inactivated culture reference standard preparations
  • DNA reference standards of product-relevant non-cultivable haemotropic Mycoplasma species ('haemoplasmas')
  • 15:40 Afternoon Tea

    16:10 Sterility sample size considerations for cellular therapies

    Timothy Wood

    Timothy Wood, President and Principal Consultant, Cell Therapy Microbiology Consulting
    View Bio

  • Rationale for the appropriate sterility sample size for cell and gene therapy products
  • Ensuring the sterility test samples are appropriate for the materials tested, scientifically sound and representative of the batch while preserving sufficient product for patients
  • Meeting regulatory expectations
  • 16:50 Container closure integrity testing

    Carol Davis

    Carol Davis, Manager QC Microbiology and Biology, Grifols, Inc
    View Bio

  • FDA guidance and expectations on container closure integrity testing
  • USP <1207> and different probabilistic and deterministic methods
  • Case Studies and potential pitfalls
  • 17:30 Chair’s Closing Remarks and Close of Day One

    James Polarine Jr

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

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Geeta Singh

    Geeta Singh, Technical Specialist III, Genentech
    View Bio

    9:10 Objectionable Organisms in Non-Sterile Drug Products – Guidance, Regulations, and Case Studies

    Stephen Langille

    Stephen Langille, Senior Microbiologist Consultant, ValSource, LLC
    View Bio

  • Definition of an objectionable organism
  • Guidance, standards and regulations relating to non-sterile products
  • Prevention of objectionable organism contamination
  • Case studies related to objectionable organisms in non-sterile products
  • Burkholderia cepacia complex
  • 9:50 Current FDA Expectations for BLA Submissions

    Scott Nichols

    Scott Nichols, Lead Microbiology Reviewer/Inspector, FDA
    View Bio

  • Regulatory Framework & Filing Process
  • Organization of Quality Micro Data in the eCTD
  • Common Filing/Review Deficiencies
     
  • 10:30 Changing the Paradigm – Moving to In-Process Release

    Scott Weiss

    Scott Weiss, Director of Industrial Microbiology, Johnson & Johnson
    View Bio

  • Problems of culture-based methods
  • What’s holding us back?
  • Benefits of real time monitoring
  • 11:10 Morning Coffee

    11:40 Alternative endotoxin test methods for products exhibiting low endotoxin recovery

    Ren-Yo Forng

    Ren-Yo Forng, Scientific Director, Amgen

  • The development of a suitable method to replace current endotoxin testing methods for products
  • A strategic approach to the evaluation and validation of testing methods
  • The future for finding a suitable replacement method – scope and reality check
  • 12:20 The challenge of viable but nonculturable (VBNC) bacteria: Induction, Detection, and Control

    Patrick-Julian Mester

    Patrick-Julian Mester, Postdoctoral Research Assistant, Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna
    View Bio

  • A short history and current definitions of the VBNC state of bacteria
  • Natural occurrence, active induction and resuscitation; What triggers the VBNC state in bacteria and what is the potential risk?
  • Live, Death and in Between; Methods and tools to detect VBNC and the current state on defining legal limits
  • Stress-resistance of VBNC bacteria as an explanation for recurring contamination; What are effective cleaning and disinfection measures?
  • 13:00 Networking Lunch

    14:00 CASE STUDY: Executing rapid transition from clinical to commercial manufacturing

  • Navigating through phase-appropriate cGMP
  • Demonstrating acceptable data integrity and management
  • Exploring the use of rapid technologies
  • Michael Bauman

    Michael Bauman, Associate Director, Seattle Genetics
    View Bio

    14:40 Emphasis on laboratory data integrity deficiencies and compliance

    Chinmoy Roy

    Chinmoy Roy, Senior Consultant, Valgensis Inc,
    View Bio

  • Frequency of non-compliant regulatory findings and FDA warning letters
  • Reassessing the definitions of data integrity and the current analytical and statistical methods to detect anomalies
  • Conducting a Laboratory Data Integrity Risk Assessment using Process Flow Charts
  • Risk-based case studies showcasing multiple approaches
  • 15:20 Afternoon Tea

    15:50 Our Sustainable Future: Integrating Sustainability into Operations, R&D, and Manufacturing

    Rachael Relph

    Rachael Relph, Chief Sustainability Officer, My Green Lab
    View Bio

  • A growing movement in laboratory sustainability: Green Lab certification
  • Sustainability integration in laboratory operations, R&D and drug manufacturing
  • Benefits in time, cost and environmental impact
  • Current techniques that align with sustainable best practices, such as RMM
  • Case Studies and recommendations for implementation to your current lab
  • 16:30 Chair’s Closing Remarks and Close of Day Two

    Geeta Singh

    Geeta Singh, Technical Specialist III, Genentech
    View Bio

    +

    FEATURED SPEAKERS

    Carol Davis

    Carol Davis

    Manager QC Microbiology and Biology, Grifols, Inc
    Chinmoy Roy

    Chinmoy Roy

    Senior Consultant, Valgensis Inc,
    Geeta Singh

    Geeta Singh

    Technical Specialist III, Genentech
    James Polarine Jr

    James Polarine Jr

    Senior Technical Service Manager, Steris Corporation
    Lynn Johnson

    Lynn Johnson

    Scientist, Takeda
    Lynne Ensor

    Lynne Ensor

    Vice President, Technical, Parexel International
    Morgan  Polen

    Morgan Polen

    Contamination Control and Cleanroom Expert, Microrite, Inc.
    Patrick-Julian Mester

    Patrick-Julian Mester

    Postdoctoral Research Assistant, Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna
    Rachael Relph

    Rachael Relph

    Chief Sustainability Officer, My Green Lab
    Renate Rosengarten

    Renate Rosengarten

    Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
    Scott Nichols

    Scott Nichols

    Lead Microbiology Reviewer/Inspector, FDA
    Scott Weiss

    Scott Weiss

    Director of Industrial Microbiology, Johnson & Johnson
    Stephen Langille

    Stephen Langille

    Senior Microbiologist Consultant, ValSource, LLC
    Sylvanie Cassard Guilloux

    Sylvanie Cassard Guilloux

    Global Solution Manager, BioMerieux
    Timothy Wood

    Timothy Wood

    President and Principal Consultant, Cell Therapy Microbiology Consulting
    Ziva Abraham

    Ziva Abraham

    CEO, Microrite, Inc.

    Carol Davis

    Manager QC Microbiology and Biology, Grifols, Inc
    Carol Davis

    Carol Davis is the Manager of Quality Control Microbiology and Biology Departments at Grifols Biologicals, Los Angeles. She obtained her Ph.D. in Molecular Microbiology from Maynooth University, Ireland. After which, she worked as a Postdoctoral Scholar in the Plant Pathology and Microbiology Department at UCR. She made the transition from Academia to Industry in 2015, working as a Principal Quality Lab Associate for Shire Pharmaceuticals. In 2017 she began working for Grifols Biologicals LLC as the Principal Scientist for the QC Microbiology and Biology Departments. In 2017 she became the Manager of these departments, and currently remains there. In this current role, she manages the operation of the laboratories and supports product release whilst ensuring regulatory compliance.

    Chinmoy Roy

    Senior Consultant, Valgensis Inc,
    Chinmoy Roy

    Chinmoy Roy is a retiree from Genentech. He is an experienced biopharmaceutical consultant with subject matter expertise in CSV, Data Integrity, CFR 21 Part 11, Annex 11 and manufacturing process automation systems. He is a member of ISPE’s Data Integrity Special Interest Group (S.I.G). His presentations blend his field experience to highlight the intricacies of implementing regulations. Chinmoy has a bachelor’s degree in Electrical Engineer and a Masters degree in Computer Science.

    Geeta Singh

    Technical Specialist III, Genentech
    Geeta Singh

    Geeta Singh has over 16 years of experience in Pharma Technical Development, at Genentech, A Member of the Roche Group. Geeta brings a broad and diverse perspective to her role as Technical Specialist in a premier Pilot Plant facility. She has experience in both mammalian and bacterial cell culture from lab to pilot plant scale. In addition to coordinating complex experiments for process development, she focuses on evaluating and implementing new technologies in analytics and process monitoring to enable faster and more efficient process development. Geeta also plays a critical role as team leader responsible for environmental monitoring, microbial controls and non-host contamination investigations in the pilot facility.
    Geeta holds a BS with honors in Business Administration from Notre Dame De Namur University, Diploma in Biotechnology, Clinical Trial Design, and Management, Pharmacy and Fashion Designing.
     

    James Polarine Jr

    Senior Technical Service Manager, Steris Corporation
    James Polarine Jr

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control 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 industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President 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.

    Lynn Johnson

    Scientist, Takeda
    Lynn Johnson

    Lynn Johnson is currently a Scientist focused in Microbiological QC Methods Lifecycle Management in the Global Microbiology Management department at Takeda Pharmaceuticals based out of Lexington, MA. In this role, she provides subject matter expertise as well as technical leadership on microbiological matters, such as method related projects, microbial control strategies, and contamination support. Ms. Johnson has over 15 years of experience in the biotechnology field and holds a Bachelor’s Degree in Microbiology from the University of New Hampshire and a Master’s Degree in Public Health from Boston University.

    Lynne Ensor

    Vice President, Technical, Parexel International
    Lynne Ensor

    Dr. Lynne Ensor is a Vice President, Technical, for Parexel. As a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. Lynne was previously employed at Roche Biomedical Laboratories, the University of Maryland at Baltimore’s School of Medicine, and earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

    Michael Bauman

    Associate Director, Seattle Genetics
    Michael Bauman

    Mike Bauman is an Associate Director at Seattle Genetics, where he leads the Quality Control laboratories at a small-scale ADC clinical manufacturing facility in Bothell, WA. His QC expertise extends into raw materials, environmental monitoring and in-process testing. Mike has over 20 years of Quality experience at both clinical and commercial biologics facilities. Mike holds a BS in Microbiology from California State University, Northridge and an MBA from Colorado State University.

    Morgan Polen

    Contamination Control and Cleanroom Expert, Microrite, Inc.
    Morgan  Polen

    Morgan Polen has been involved with cleanrooms and contamination control since 1984. He has worked in over 40 countries involved with projects ranging from cleanroom design, construction, validation, AFV, monitoring programme development, particle counter design and product management for cleanroom related products and systems. He has addressed monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical and others. Morgan is a member of IEST’s US Technical Advisory Group to ISO/TC 209 Cleanrooms and Associated Controlled Environments, participating in the process of adapting the latest cleanroom standards.

    Patrick-Julian Mester

    Postdoctoral Research Assistant, Christian Doppler Laboratory for Monitoring of Contaminants, University of Veterinary Medicine, Vienna
    Patrick-Julian Mester

    Dr. Patrick Mester is currently a group leader at the Christian-Doppler Laboratory for Monitoring of Microbial Contaminants in Vienna, Austria. Originally from Germany, Patrick graduated in Microbiology and Molecular Biology at the University of Bremen. For over ten years, he is involved in researching and developing diagnostic tools and methods for bacterial pathogens at the University of veterinary medicine in Vienna. In his current position, he is studying the role of viable but nonculturable bacteria in persisting bacterial contaminations and possible control and intervention measures.

    Rachael Relph

    Chief Sustainability Officer, My Green Lab
    Rachael Relph

    Rachael is the Chief Sustainability Officer at My Green Lab, a non-profit organization dedicated to building a culture of sustainability through science. Rachael helps scientists identify greener laboratory practices through education, outreach and a Green Lab Certification program. Prior to joining My Green Lab, Rachael led Design for Environment and Sustainability initiatives for Life Technologies and Thermo Fisher Scientific. On weekends and holidays Rachael enjoys camping, biking or hiking with her family and friends. One day she hopes to hike the entire Pacific Crest Trail from Mexico to Canada.

    Renate Rosengarten

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

    Prof Renate Rosengarten’s career originated from her academic research work 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 has been 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), Scientific Advisory Board Member of the German Robert Koch Institute (RKI) in Berlin, 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 area of mycoplasma safety testing. In addition to her academic duties as mentor, lecturer, reviewer, scientific advisor, and committee member, Prof Rosengarten serves since 2004 as an independent mycoplasma expert, key opinion leader and consultant for biopharma, biotech and cell therapy companies under her own international brand Mycosafe® and has recently established a consulting and out-licensing enterprise.

    Ren-Yo Forng

    Scientific Director, Amgen
    Ren-Yo Forng

    Scott Nichols

    Lead Microbiology Reviewer/Inspector, FDA
    Scott Nichols

    Scott Nichols graduated from the University of Iowa with an Honors BS in Biochemistry and continued as a Fulbright Scholar at the Pasteur Institute. His Ph.D. was earned in Molecular Biophysics at Johns Hopkins University. He currently works as a Quality Assessment Lead in the Division of Biotechnology Manufacturing at the FDA. He has expertise in the microbial control/sterility assurance review of biotechnology drug substance/drug product applications and leads inspections of the associated manufacturing facilities. He is an author of PDA’s Technical Report No. 82 on Low Endotoxin Recovery and works on microbial control strategies for emerging technologies.

    Scott Weiss

    Director of Industrial Microbiology, Johnson & Johnson
    Scott Weiss

    Scott Weiss is the Director, Industrial Microbiology at J&J Microbiological Quality & Sterility Assurance (MQSA) and is responsible for supporting microbiological quality for products and processes across Johnson & Johnson. Scott is a member of the J&J MQSA Leadership Team and a Co-lead for the J&J Industrial Microbiology Council. He has served as a trainer to the FDA for Ethlyene Oxide use and calculations for reduced gas consumption without impacting product Sterility Assurance Levels, as well as microbiological methods for bioburden analysis. Scott currently is a member of multiple cross-company industry consortiums, AAMI, and presently leads the Environmental Monitoring Task Force for the PDA.

    Stephen Langille

    Senior Microbiologist Consultant, ValSource, LLC
    Stephen Langille

    Stephen Langille received his B.S. in biology from the University of Massachusetts and his Ph.D. in microbiology from the University of Maryland. He worked for the FDA for 19 years as a Microbiology Reviewer, Branch Chief, and Director of the Center for Drug Evaluation and Research’s Division of Microbiology Assessment where he oversaw the review and evaluation of sterile and non-sterile drug product manufacturing controls and finished product testing. He currently works as a Senior Microbiology Consultant at ValSource, Inc.

    Sylvanie Cassard Guilloux

    Global Solution Manager, BioMerieux
    Sylvanie Cassard Guilloux

    Sylvanie has a strong scientific background (PhD at Paris VII University; post-doctoral experience at Rockefeller University) in cellular and molecular biology. On her return to France, Sylvanie joined industry, and had 13 years of experience as technical leader or in R&D in several laboratories, developing and using molecular methods for industry quality controls, while she also participated to standardization of these methods as a group leader at the french normalization body (AFNOR). In 2012, after a Master of Business at Audencia business school, she joined the global marketing department of bioMérieux, where she is defining and guiding the development of new solutions for pharmaceutical microbiological controls.

    Timothy Wood

    President and Principal Consultant, Cell Therapy Microbiology Consulting
    Timothy Wood

    Timothy Wood has 30 years experience in Microbiology in cGMP industry. Tim is Principal Consultant at Cell Therapy Microbiology Consulting which he created primarily for cellular therapies to develop and improve contamination controls, including EM programs and rapid sterility tests. At Dendreon Tim helped get PROVENGE? the first FDA approved cellular immunotherapy through investigational trials, approval, and product launch at multiple commercial cGMP facilities. Tim developed the FDA approved BacT/Alert? 7-day sterility test for PROVENGE increasing sterility assurance and product safety release. Tim has worked as a Microbiologist at companies including ICOS, Xcyte Therapies, CellPro, and Abbott Laboratories. Tim received his Bachelor's degree in Biology from Pacific Lutheran University, Tacoma, WA.

    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 25 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

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Data Integrity in Environmental Monitoring: Causes and Solutions
    Workshop

    Data Integrity in Environmental Monitoring: Causes and Solutions

    Hyatt Regency Mission Bay
    16th June 2021
    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

    Two Day Program 2020

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    2020 Conference Speakers

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    Half Day Pre-Conference Workshop Programme 2020

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    Pharmaceutical Microbiology West Coast 2020 Brochure

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    Past attendees (2017-2019)

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    Pharma Micro West Coast Past Presentation 2019 - Global QC Roche-Genentech

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    Pharma Micro West Coast Past Presentation 2019 - Abbott Laboratories

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    Pharma Micro West Coast Past Presentation 2019 - Associates of Cape Cod

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    Pharma Micro West Coast Past Presentation 2019 - Steris

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    Pharma Micro West Coast Past Presentation 2019 - Takeda Pharmaceuticals

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    Pharma Micro West Coast Past Presentation 2019 - Bristol-Myers Squibb

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    Pharma Micro West Coast Past Presentation 2019 - University of Veterinary Medicine Vienna

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    Sponsors


    Associates of Cape Cod

    Sponsors
    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
    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
    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.

    Exhibitors


    Microcoat

    Exhibitors
    http://www.microcoat.de

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

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



    MilliporeSigma

    Exhibitors
    https://www.emdmillipore.com/US/en?bd=1

    MilliporeSigma is a top player in industrial microbiology and process monitoring providing state-of-the-art testing methods, regulatory expertise, and outstanding service to provide that one invaluable result: maintaining the safety of your products. The portfolio includes hardware, consumables, validation, and method development for bioburden, sterility, environmental monitoring, and media fill.

    Media Partners


    Select Science

    Official Media Partner
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    Biocompare

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

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


    Colorado Bioscience

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

    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.

    Media Partners


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    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.


    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


    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.


    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.


    Farmavita

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


    Genetic Engineering News

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    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    IPI

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    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.


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    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    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


    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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    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.


    EIN News

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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.


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    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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    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


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    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.


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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.


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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    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.

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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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