Home
Pharmaceutical Microbiology East Coast
November 13 - November 14, 2017
Pharmaceutical Microbiology East Coast

Due to the huge success of their UK event, SAE Media Group is delighted to present Pharmaceutical Microbiology East Coast, coming to New Jersey in November 2017!

The demand for rapid microbiology in the pharmaceutical industry is at an all-time high, with regulatory bodies expressing their concern about product safety, and the microbiology market constantly growing.
This continuous expanding of the market brings many new challenges, which need to be addressed to ensure prevention of contamination and other safety issues.

SAE Media Group’s Pharmaceutical Microbiology East Coast conference will not only discuss the challenges facing the microbiology field regarding the topic of contamination control and cleanrooms, but also take a closer look at strategies for rapid microbial sterility testing, the importance of environmental monitoring to prevent potential risks, bacterial endotoxin testing, quality control and new technologies, as well as regulatory issues and updates, such as the new draft of the annex 1.

 

The 2017 East Coast programme will feature industry relevant presentations and case studies, and an all-new senior professional speaker line-up. Join us this November to expand your knowledge in the microbiology field at this unmissable networking conference!

FEATURED SPEAKERS

Geeta Singh

Geeta Singh

Pilot Plant Technical Specialist III, Genentech
Joseph Chen

Joseph Chen

Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical
Shahram Lavasani

Shahram Lavasani

CEO, ImmuneBiotech AB
Tony Van Hoose

Tony Van Hoose

CEO & Founder, Global Aseptic Process Solutions, L.L.C.

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.

Frederic Ayers

Consultant Scientist, Indianapolis Parenteral Operations, Eli Lilly And Company
Frederic Ayers

Mr. Frederic B. Ayers received a B.A. degree in Biology from Franklin College. After graduating, he spent two years working in the contract manufacturing industries (pharmaceutical, food) prior to joining Eli Lilly and Company in 2001. Since joining Lilly, Mr. Ayers has held various technical positions from which he has helped advance Lilly's state of regulatory compliance. He is responsible for developing and implementing sterility assurance related strategies at Lilly’s Indianapolis parenteral manufacturing site. Additionally, Fred is responsible for aligning the sterility assurance strategy throughout the company’s parenteral network.

Geeta Singh

Pilot Plant 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 Hauschild

Principal Scientist, Johnson & Johnson
James Hauschild

Jim Hauschild is a broadly trained Ph.D.-level microbiologist who is currently responsible for helping promote industrial microbiology innovations within J&J Sterility Assurance. Jim is a subject matter expert in rapid microbiological methods (RMM) and has a proven track record performing RMM feasibility assessments, assisting with RMM implementations and utilizing RMM instrumentation to design and execute in vitro antimicrobial proof-of-principle studies to help support product and business development within J&J. Jim is also knowledgeable in conventional sterilization technologies and sterilization process validation and has experience working with J&J new product development teams on difficult to sterilize products.

Jim Polarine

Senior Technical Service Manager, STERIS Corporation
Jim Polarine

WORKSHOP LEADER B: "CONTAMINATION CONTROL IN CLEANROOMS"

 

Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen 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. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group. He is president elect with the PDA Missouri Valley Chapter. He is part of the faculty at the University of Tennessee Parenteral Medication course. He is also active with the IEST Special Topics Committee on Cleaning and Disinfection. He has presented at key industry venues for NASA, USP, PDA, ISPE, FDA, SIMB, GBPR, IPA, AALAS, IVT, IEST, University of Tennessee, SWE, STERIS Applied Sterilization Technologies, and Barnett International on cleaning and disinfection, disinfectant validation, and contamination control. Mr. Polarine frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, STERIS, and Executive Conferences. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, SIMB, ISPE, IEST, ASM, ASTM, AAAS, AOAC, and ACS. 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.

Joseph Chen

Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical
Joseph Chen

Dr. Chen is responsible for the QC function in all CMC analytical aspects from clinical production to NDA/BLA/MAA and product life cycle management at Ultragenyx. This includes operational and technical QC method development, validation and transfer for biologics and small molecule products manufactured at CMOs.

Prior to joining Ultragenyx in 2015, he was the Director of Global Biologics Quality Control at Genentech/Roche, managing analytical method/technology and global microbiological control programs for 10 biologics production sites and IMP products manufactured at CMOs.

Dr. Chen did his graduate study at UCSF on developing kinetic LAL assays and holds a PhD in Microbiology and Immunology from University of Rochester in New York. He has 25+ years of business and biopharmaceutical experience, including research and development, quality control, product safety compliance, regulatory CMC and risk management.

Mengyan Li

Assistant Professor, New Jersey Institute of Technology
Mengyan Li

Mengyan “Ian” Li is an assistant professor in the Department of Chemistry and Environmental Science at New Jersey Institute of Technology. He received his Ph.D. degree in Environmental Engineering from Rice University in 2013. His primary research interest focuses on uncovering novel biodegradation metabolisms and biotransformation pathways for emerging contaminants and designing genetic forensic tools to facilitate the assessment of microbiological activities in environment. His research has been widely reported by news and web media. His novel catabolic biomarker design to evaluate natural attenuation of 1,4-dioxane won the AAEES Honor Award for the Excellence in Environmental Engineering and ScienceTM Competition.

Rajesh Shukla

Vice President Clinical Operations, Motif bio
Rajesh Shukla

Dr. Rajesh Shukla is Vice President of Clinical Operations at Motif BioSciences, Inc. Dr. Shukla brings drug discovery, development, and operations experience from entrepreneurial and established pharmaceutical companies. Prior to joining Motif, Dr. Shukla headed clinical development programs in Infectious Diseases, CNS, Oncology, Endocrinology, Asthma, and Anaphylaxis at Pfizer, Bristol-Myers Squibb, Bracco, Teva and Acorda. He began his pharmaceutical career at Bristol Myers-Squibb with a discovery focus in Oncology, CNS, and clinical trial experience in anti-infectives. Dr. Shukla completed his bachelor’s degree in Biochemistry from Lehigh University, his Ph.D. from Carnegie-Mellon University and a postdoctoral fellowship at Yale University.

Robert Ferer

Strategic Practice Lead, Quality Executive Partners (QxP)
Robert Ferer

WORKSHOP LEADER A: "NAVIGATING THE REQUIREMENTS OF A MODERN QC MICROBIOLOGY LABORATORY"

Shahram Lavasani

CEO, ImmuneBiotech AB
Shahram Lavasani

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

Shawn Sweeney

Sr. Process Development Manager, Charles River
Shawn Sweeney

Tony Cundell

Principal Consultant, Microbiological Consulting, LLC
Tony Cundell

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

He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report #67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. Recently he received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science.

Tony Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand.

Tony Van Hoose

CEO & Founder, Global Aseptic Process Solutions, L.L.C.
Tony Van Hoose

Tony has been involved in the pharmaceutical industry for over 35 years as a Quality Assurance/Quality Control professional both for operating companies and as a consultant. Tony holds a B.S. degree in Microbiology from Auburn University. He has been a presenter at numerous IVT, ISPE, PDA and ASM conferences and has been an invited presenter for the FDA Aseptic Process Inspector Training classes. Currently Tony is employed as a Director of Sterile Technologies Expertise in the Global Manufacturing Quality Operations group at Sanofi. In this role he supports all of the sterile injectable manufacturing sites in from a Quality technical standpoint and manages a sterile technology network within Sanofi to drive harmonization of policies, procedures and best practices throughout the Sanofi group. Currently he is focused on the harmonization of aseptic manufacturing technologies and specifically technologies involving RABS and isolator filling systems and best practices for visual inspection of both final product and aseptic process simulation containers.

Vanessa Vasadi-Figueroa

Partner / Microbiologist, Quality Executive Partners (QxP)
Vanessa Vasadi-Figueroa

WORKSHOP LEADER A: "NAVIGATING THE REQUIREMENTS OF A MODERN QC MICROBIOLOGY LABORATORY"

 

Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 12 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Mrs. Figueroa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Mrs. Figueroa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz, and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Veronika Wills

Technical Services Associate Manager, Associates of Cape Cod
Veronika Wills

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

sponsors

Conference agenda

clock

8:30

Registration & Coffee

clock

9:00

Opening Remarks

clock

9:10

Session 1 - The Modern Microbiology Lab

  • Learn about current trends in QC Microbiology
  • Solutions for when to upgrade technology in your lab

  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)

    clock

    9:50

    Session 2 - Real Time Release Testing

  • Learn about options available for monitoring water & products in real time
  • Discuss the creation and application of new excursion criteria
  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Session 3 - Data Integrity in a Digital Lab

  • Application of Data integrity for conventional & alternative lab methods
  • Practical approaches & safeguards against common mistakes
  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)

    clock

    11:40

    Session 4 - The iMicrobiologist

  • Blending old & new technologies in the QC Microbiology lab
  • Understanding, hiring & training the new generation of talent

     

     

  • Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)

    clock

    12:20

    Closing Remarks

    clock

    12:30

    Close of Workshop

    clock

    13:30

    Registration & Coffee

    clock

    14:00

    Opening Remarks

    clock

    14:10

    Session 1 – Common Sources of Contamination: Case Studies

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    clock

    14:50

    Session 2 – A Risk Based Cleaning and Disinfection Program

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    clock

    15:30

    Afternoon Tea

    clock

    16:00

    Session 3 – Key Elements of a Successful Disinfectant Validation Program

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    clock

    16:40

    Session 4 – Bringing the Cleanroom Online After a Worst-Case Event

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    clock

    17:20

    Closing Remarks

    clock

    17:30

    Close of Workshop

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chair's Opening Remarks

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech

    clock

    9:10

    The Role of Microbiology in Pharmaceutical Stability Programs

    Tony Cundell, Principal Consultant, Microbiological Consulting, LLC

  • Stability Study Requirements: R&D versus Marketed Products
  • What Microbial Tests are Stability Test Parameters
  • Stability Testing Appropriate for Different Dosage Forms
  • Managing the Stability Commitments in your Regulatory Filings
  • Investigating Stability Test Failures
  • clock

    9:50

    How does a Non-GMP Biopharmaceutical Pilot Facility deliver high run rate with high success?

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech

  • CHO and E. coli process development overview
  • Provide an overview of the premier Pilot Plant facility in Biotech USA that executes more than 1500 CHO and E. coli experiments per year to support Genentech’s pipeline
  • Discuss microbial contamination case studies and the lessons learned
  • Discuss how critical it is to maintain good health of the non-GMP facility to achieve high success rate

  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Amplified ATP Bioluminescence Rapid Sterility Test Validation Utilizing a Defined Method for Stressing Microorganisms

    Shawn Sweeney

    Shawn Sweeney, Sr. Process Development Manager, Charles River

  • Provides an efficient, and reproducible method for generating log reductions in microbial cultures
  • Comparative data / illustrations shall be presented to demonstrate stressing procedural efficacy
  • The impact of stressed organisms on Time to Detect, and Limit of detection shall be demonstrated
  • clock

    11:40

    Adoption of new technology within the pharmaceutical microbiology field

  • Barriers towards implementation
  • The regulatory red-tape surrounding this
  • Q&A
  • Tony Cundell, Principal Consultant, Microbiological Consulting, LLC

    Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical

    Andrew Bartko, Research Leader, Battelle Memorial Institute

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    clock

    12:20

    Networking Lunch

    clock

    13:30

    Benefits of Real-time Monitoring of Airborne Viable Microorganisms

    James Hauschild, Principal Scientist, Johnson & Johnson

  • Bio-fluorescent active air particle counting of airborne viable microorganisms
  • Continuous real-time Environmental Monitoring of Classified Environments
  • Risk mitigation
  • clock

    14:10

    Iclaprim, a novel diaminopyrimidine, for the treatment of serious Gram-positive infections

    Rajesh Shukla, Vice President Clinical Operations, Motif bio

  • Iclaprim addresses an unmet medical need in hospitalized patients with serious and life threatening infections including MRSA
  • Iclaprim possesses a differentiated product profile in target patient populations
  • Iclaprim provides a near-term product opportunity

  • clock

    14:50

    Rapid microbial-detection methods

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • The benefits, applications, pitfalls and challenges involved
  • Time to result benefits to manufacturing economics
  • Enhanced quality control impact on manufacturing risk
  • Overcoming the hurdles of new technology validation

  • clock

    15:30

    Afternoon Tea

    clock

    16:00

    Quality Control Strategy on Low Endotoxins Recovery (LER)

    Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical

  • Discuss common formulation ingredients in biologics cause LER
  • Risk assessment approach in mitigating LER impact on product quality
  • Case study on analytical solution to LER and alternatives

  • clock

    16:40

    Chair’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chair's Opening Remarks

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech

    clock

    9:10

    PDA’s Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

  • The newly released PDA Technical Report No. 70 covering Cleaning and Disinfection. 
  • Key areas of the technical report including industry definitions, regulatory inspections, disinfectant validation, cleaning and disinfection frequencies, disinfectant rotation and resistance, facility shut downs, and conducting root cause investigations related to cleaning and disinfection.
  • Discussions covering how this new technical report compares and relates to Europe, Asia, and Latin America as far as benchmarking industry best practices.
  • clock

    9:50

    Training of Media Fill Inspection Operators

    Tony Van Hoose, CEO & Founder, Global Aseptic Process Solutions, L.L.C.

  • Training Program Overview
  • Creation of Positive Containers
  • Test/Inspection Conditions
  • Certification of Operators
  • Recertification/Retraining – Frequency and Basis

  • clock

    10:30

    Morning Coffee

    clock

    11:00

    KEY NOTE ADDRESS: Implementation of a Global Electronic Intervention Logging System

    Frederic Ayers, Consultant Scientist, Indianapolis Parenteral Operations, Eli Lilly And Company

    Sterility is one of the most critical quality attributes that all parenteral products must possess; yet, it is one of the most difficult to consistently and convincingly demonstrate. This presentation discusses an integrated, cross-functional strategy implemented within Eli Lilly and Company’s parenteral manufacturing network. This strategy identifies, assesses, documents, and evaluates the single largest source of microbial hazard within aseptic filling areas – aseptic personnel.

     

  • This presentation will describe an Aseptic Manipulation and Intervention Program, which establishes the requirements for how aseptic interventions and manipulations are identified, assessed, and executed
  • This presentation will describe the Intervention Logging System which allows for real-time electronic documentation of interventions performed on aseptic filling lines
  • This presentation will describe the Intervention Logging System which allows for real-time electronic documentation and approval of non-coded interventions performed on aseptic filling lines
  • This presentation will describe the use of RFID for documentation of Electronic Signature for activities within the aseptic areas

     

    Collectively, these provide quantifiable information that helps mitigate the risk of personnel-induced microbial hazard of products filled in aseptic environments. The discussion of these programs, along with several examples of how the data can be used to make quality decisions, will provide attendees with ideas of how microbiology process controls work together to provide evaluation of sterility assurance and data integrity.

     

    The attendees will understand the importance of developing a robust intervention strategy with appropriate definitions of activities. Additionally, identifying, assessing and mitigating all aseptic interventions and manipulations allow for consistent evaluation of filler performance across a platform.

  • clock

    11:40

    Endotoxin detection – What you need to know when running a quantification test

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

  • Understanding the data of the kinetic photometric tests and the potential outcomes
  • Understanding the resolution of the test
  • In-depth discussion on inter-assay variability of the test and the causes
  • How to keep inter-assay variability under control
  • clock

    12:20

    Networking Lunch

    clock

    13:30

    Designed microbiome therapies targeting the microbes and beyond

    Shahram Lavasani, CEO, ImmuneBiotech AB

  • The gut microbiome plays an essential role in disease regulation and efficacy of therapies. Altered microbial communities, also termed dysbiosis, has been observed in many intestinal and extra-intestinal inflammatory disorders
  • There is not yet a clear understanding whether dysbiosis is a cause or a consequence of the diseases. Microbial therapies which only target the dysbiosis have shown limited success
  • A healthy gut microbiota exists in an equilibrium with the gut barrier and the immune system
  • The importance of multiple-target drug cocktails comprising commensal bacteria will be discussed. The bacterial library, screening technologies and design of potential and affordable drugs will be presented with particular focus on successful products that treat Irritable Bowel Syndrome (IBS) and Clostridium Difficile Infection

  • clock

    14:10

    Biological Treatment of Emerging Contaminants Prevalent in Pharmaceutical Effluents

    Mengyan Li, Assistant Professor, New Jersey Institute of Technology

  • Pharmaceutical wastewater commonly consists of contaminants of emerging concerns, such as antibiotics, estrogens, and 1,4-dioxane
  • Bacteria that can degrade or biotransform these xenobiotic compounds are more widespread than previously recognized
  • Modern culture-independent biotechnologies facilitate the identification of microorganisms with unique biotransformation capabilities
  • Biologically active filtration system is one of top effective and economical techniques for removal of commingled emerging contaminants in pharmaceutical waste streams
  • clock

    14:50

    Chair’s Closing Remarks and Close of Day Two

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech

    clock

    15:00

    Afternoon Tea


    Research Leader
    Battelle Memorial Institute
    Consultant Scientist, Indianapolis Parenteral Operations
    Eli Lilly And Company
    Pilot Plant Technical Specialist III
    Genentech
    Principal Scientist
    Johnson & Johnson
    Senior Technical Service Manager
    STERIS Corporation
    Executive Director, CMC Quality Control
    Ultragenyx Pharmaceutical
    Assistant Professor
    New Jersey Institute of Technology
    Vice President Clinical Operations
    Motif bio
    Strategic Practice Lead
    Quality Executive Partners (QxP)
    CEO
    ImmuneBiotech AB
    Sr. Process Development Manager
    Charles River
    Principal Consultant
    Microbiological Consulting, LLC
    CEO & Founder
    Global Aseptic Process Solutions, L.L.C.
    Partner / Microbiologist
    Quality Executive Partners (QxP)
    Technical Services Associate Manager
    Associates of Cape Cod

    Sponsors and Exhibitors

    Official Media Partner

    Official Publication

    Supporters

    Workshops

    Contamination Control in Cleanrooms

    Contamination Control in Cleanrooms

    Renaissance Woodbridge Hotel
    November 15, 2017
    Iselin, USA

    Pharmaceutical Microbiology: Under the Microscope - Techniques & Concepts with GSK

    Download

    Advancing the Discipline of Pharmaceutical Microbiology with Quality Executive Partners

    Download

    PHARMA WEEK USA 2017 ATTENDEE LIST

    Download

    ATTENDEE LIST FOR PHARMA MICRO EAST COAST & SUPERBUGS USA 2017

    Download

    The Greatest Regulatory Challenges For Pharmaceutical Microbiology with Motif Biosciences

    Download

    Interview with JOSEPHINE CHAN, MICROBIOLOGY SUPERVISOR, TELIGENT PHARMA INC.

    Download

    Sponsors and Exhibitors


    Associates of Cape Cod, Inc.

    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 more than 40 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    bioMérieux

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

    bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.


    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.


    Neutec Group

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

    Neutec Group provides cost effective instrument solutions which enhance efficiency and productivity of pharmaceutical, microbiology and quality control labs. Stop by to discuss your microbiology work flow with our equipment specialists. Neutec Group supplies a full line of the highest quality laboratory equipment in a joint venture with premier instrument manufacturers from around the world. Founded in 2003 we provide the North American market access to the latest selection of quality products and systems with excellent competitive value.


    STERIS

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

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.


    Media Partners


    American Pharmaceutical Review

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

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    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.


    Rapid Micro Biosystems

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

    Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The company’s flagship Growth Direct® platform automates and modernizes the antiquated, manual microbial quality control (MQC) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct® platform brings the quality control lab to the manufacturing floor, unlocking the power of in-line/at-the-line MQC automation to deliver faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, and global locations in Switzerland, Germany, and the Netherlands.

    Media Partners


    International Journal of Computational Microbiology and Medical Ecology

    Official Publication
    http://www.inderscience.com/ijcmme

    IJCMME publishes original research contributions on computational microbiology, microbial bioinformatics, and medical ecology. It also covers all aspects of computational microbial ecology. The journal particularly welcomes contributions from studies in the Human Microbiome Project (HMP) and its ramifications in personalised medicine, and considers human microbiome research as a vitally important field of medical ecology, beyond the scope which the eminent microbiologist René Dubos provided regarding the subject several decades ago.


    International Journal of Ecological Bioscience and Biotechnology

    Official Publication
    http://www.inderscience.com/ijebb

    IJEBB is a peer-reviewed journal offering authors and readers opportunities to share the latest concepts and developments in the increasingly-significant field of ecological bioscience and biotechnology, access current case studies in ecological engineering and explore the market potential for ecological biotechnologies. It covers applications of ecological technology and scientific discoveries to the natural environment, human habitation and environmental sustainability. IJEBB provides a key forum to bring together state-of-the-art research of interest to scientists, engineers and policymakers in related fields worldwide.


    International Journal of Environment and Health

    Official Publication
    http://www.inderscience.com/ijenvh

    IJEnvH is a fully-refereed scientific journal that provides an international forum for the exchange of information and the advancement of knowledge in the multidisciplinary field of environment and health. The aim of IJEnvH is to stimulate the discussion and communication among scientists, researchers and experts with different background and expertise, involved, at different levels, with the study of environment and health problems.

    Media Partners


    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
    https://farmavitar.com

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


    Contract Biotechnology

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

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    MDPI Biology Journal

    Supporters
    http://www.mdpi.com/journal/biology

    Biology (ISSN 2079-7737, http://www.mdpi.com/journal/biology) is an international, peer-reviewed, quick-refereeing open access journal of Biological Science. This journal is supervised by Editor-in-Chief, Prof. Dr. Chris O'Callaghan and Associate Editor, Prof. Dr. Jukka Finne. Biology is supported by an outstanding Editorial Board which includes a 2002 Nobel Laureate as well as other excellent scientists (http://www.mdpi.com/journal/biology/editors/). Biology is indexed by PubMed, Zoological Record, Scopus, etc (http://www.mdpi.com/journal/biology/indexing).


    One Nucleus

    Supporters
    http://www.onenucleus.com

    Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Pharmaceutical-Review

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

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


    Biocompare

    Supporters
    http://www.biocompare.com

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


    Mednous

    Supporters
    http://www.MedNous.com

    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


    Medical Device Network

    Supporters
    http://www.medicaldevice-network.com/

    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.


    SelectScience

    Supporters
    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    EIN Presswire

    Supporters
    http://www.einpresswire.com/free

    EIN Presswire has a distribution "foot-print" that includes millions of users of our EIN Newsdesk media monitoring services. We also maintain one of the world's leading media directories providing us with up-to-date contacts for media in every country and U.S. state. Further distribution is achieved via RSS, email, partner websites, and social media. We are both a destination (EIN Newsdesk) and a distributor (EIN Presswire) for news. In one place you can distribute your news to the targeted audiences you select and monitor news on that topic published by thousands of worldwide sources. For more information or to try us FREE, please visit www.einpresswire.com/free


    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

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


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Technology Networks

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

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


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    GBI

    Supporters
    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    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.


    Pharmaceutical Technology

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

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media 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@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

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

    Thank you for visiting our event

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

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

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.