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Post event on demand access to recorded presentations will be available to all attendees 5 working days from the end date of the event.

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SMi’s 4th Annual Conference
Pharmaceutical Microbiology West Coast
June 17th – 18th, 2021 | Virtual Conference: Online Access Only
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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, and novel testing methods, this industry is ever expanding.

Join industry experts to discuss the latest topics and pressing challenges in this field. Network with 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.

We look forward to welcoming you to the conference.
 

  • Discuss the guidance, regulations and case studies for objectionable organisms in non-sterile drug products from ValSource, Inc.
  • Gain insight into changing paradigms – moving to in-process testing from Johnson & Johnson
  • Examine alternative endotoxin test methods for products exhibiting LER from Amgen
  • Explore how to effectively scale up from clinical to commercial in three moves from Bristol-Myers Squibb
  • Join us for our Panel Discussion on ‘Culturing’ successful women microbiologists
  • Discover myths, mistakes, and consequences in non-viable particle monitoring from Microrite
  • Learn how to build a Global Contamination Control Program with Takeda
  • Virtual Conference Benefits include virtual exhibition booths packed with information, networking features to chat and share contact details with other attendees, and virtual meetings and networking socials

 

 

The SMi Virtual Conference Platform will deliver the following benefits:

Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality

Validation Managers, Senior Microbiologists, Quality Control Managers, Quality Assurance Experts, Leaders in Sterility Assurance, Cleanroom Managers, Regulatory Affairs Managers, Production Managers, Quality Systems Managers.
 


 

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

All timings are in Pacific Daylight Time (BST-8)

8:00 Chair's Opening Remarks

James Polarine Jr

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

8:10 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
  • 8:40 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
  • 9:10 Considerations for BET process improvement and sustainability

    Ruth Noé

    Ruth Noé, Senior Product Manager, Lonza
    View Bio

    • Identify high risk data integrity and compliance steps in current Bacterial endotoxins testing practices
    • Process bottlenecks in BET
    • Boosting efficiency, productivity, compliance and data integrity with automation and digitization
    • Future-proofing your BET program
     

    9:50 Morning Break and Virtual Exhibit Hall Open

    10:05 Non-viable particle monitoring: Myths, mistakes and consequences

    Morgan  Polen

    Morgan Polen, SME, Cleanroom Contamination Control 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
  • 10:35 Paper Based Compliance versus Factual Contamination Control

    Ziva Abraham

    Ziva Abraham, President, 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
  • 11:05 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, RCS Head of Global Compliance, Parexel International
    View Bio

    Geeta Singh

    Geeta Singh, Associate Site Director, Smartlabs
    View Bio

    Ziva Abraham

    Ziva Abraham, President, Microrite, Inc.
    View Bio

    Lynn Johnson

    Lynn Johnson, Principal Scientist, Takeda
    View Bio

    11:35 Networking Break and Virtual Exhibit Hall Open

    12:35 Mycoplasma Testing Made Simple: Sample to Results in Less than One Hour

    Lori Daane

    Lori Daane, Director of Scientific Affairs, bioMérieux, Inc
    View Bio

  • Easy, Rapid, At-Line Mycoplasma Testing on Demand
  • Overview of Workflow, Software, and Results
  • Internal Validation and Marketing Evaluation Studies
  •  

    13:15 USP Underscores Cell/Gene Therapy Progress with Development of New Chapters

    Don Singer

    Don Singer, Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
    View Bio

    • Developing appropriate assurance for contamination control using closed systems, USP <1211> and <1116>
    • Increasing options for modern microbial contamination testing of short-life products, USP <72>, <73>, <1071>
    • Improving testing turnaround time for adventitious agents such as Mycoplasma and Bacterial Endotoxins
    • Phase appropriate compliance can meet patient safety standards with appropriate microbiological controls
     

    13:45 Afternoon Break and Virtual Exhibit Hall Open

    14:00 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
  • 14:30 Real time Microbial detection – Process control and implementation of online Microbial monitoring for pharmaceutical water

    Arundhati Samanta

    Arundhati Samanta, Global Product Manager, Mettler Toledo
    View Bio

    • Review of Pharmacopeia and Regulatory positions on adoption of alternative microbial methods
    • Case study of implementation of online microbial monitoring in a Global Pharmaceutical facility
    • Guidance for evaluation and establishment of new Microbial limits
     

    15:10 Chair’s Closing Remarks and Close of Day One

    James Polarine Jr

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

    8:00 Chair's Opening Remarks

    Geeta Singh

    Geeta Singh, Associate Site Director, Smartlabs
    View Bio

    8:10 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
  • 8:40 The Truth of Endotoxin Values – Points for Consideration During Investigation of Aberrant BET Results

    Johannes Reich

    Johannes Reich, Managing Director, Microcoat Biotechnologie GmbH
    View Bio

  • The nature of endotoxin
  • Methods for endotoxin detection
  • Case studies: Challenging test results from daily testing
  • 9:20 Morning Break and Virtual Exhibit Hall Open

    9:35 A Holistic Approach to Conservation and Recombinant Technology

    • An overview of current conservation/sustainability status of the horseshoe crab population in the US
    • New developments in recombinant technologies
    • Update on the regulatory framework around recombinant reagents
    • Sharing comparability data
     

    Veronika Wills

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

    Brett Hoffmeister

    Brett Hoffmeister, LAL Production Manager, Associates of Cape Cod, Inc.
    View Bio

    10:15 The challenge of viable but nonculturable (VBNC) bacteria: Induction, Detection, and Control

    Patrick-Julian Mester

    Patrick-Julian Mester, Postdoctoral Research Assistant, Institute of Food Safety, Food Technology and Veterinary Public Health, 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?
  • 10:45 Networking Break and Virtual Exhibit Hall Open

    11:15 Building a Global Contamination Control Program

    Lynn Johnson

    Lynn Johnson, Principal 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
  • 11:45 Microbial Control Strategy aspects for an individualized ATMP

    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy), Genentech, Inc
    View Bio

    • Product and Process overview
    • Overall risk profile
    • In-process testing
    • Rapid sterility testing
    • Considerations for raw materials
     

    12:15 A Comprehensive Six-Year Study of Pharmaceutical Cleanroom Microflora

    Edward Tidswell

    Edward Tidswell, Executive Director, Microbiology QA, Merck & Co, Inc.
    View Bio

  • Six years of microflora from a multi-product sterile and non-sterile pharmaceutical manufacturing facility
  • Microorganisms identified to species level, trended, categorized and interpreted
  • >10,000 isolates of metadata benchmarking
  • Interpretation and recommendations for environmental control and monitoring (including rapid technologies)
     
  • 12:45 Afternoon Break and Virtual Exhibit Hall Open

    13:00 Implementing a Contamination Control Strategy

    Alison Laughlin

    Alison Laughlin, Associate Director, Sterility Process Assurance - Aseptic, Boehringer Ingelheim Animal Health
    View Bio

    • Elements of a Contamination Control Strategy (EU GMP Annex 1 Rev. 12 Draft)
    • Developing a Global Contamination Control Strategy Procedure and Template
    • Documenting the Contamination Control Strategy
    • Benefits of Having a Well Defined Contamination Control Strategy
     

    13:30 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
  • 14:00 Chair’s Closing Remarks and Close of Day Two

    Geeta Singh

    Geeta Singh, Associate Site Director, Smartlabs
    View Bio

    +

    FEATURED SPEAKERS

    Alison Laughlin

    Alison Laughlin

    Associate Director, Sterility Process Assurance - Aseptic, Boehringer Ingelheim Animal Health
    Arundhati Samanta

    Arundhati Samanta

    Global Product Manager, Mettler Toledo
    Brett Hoffmeister

    Brett Hoffmeister

    LAL Production Manager, Associates of Cape Cod, Inc.
    Christine Massaro

    Christine Massaro

    Director, Sterile and Microbiology Quality Assurance, Organon
    Don Singer

    Don Singer

    Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
    Edward Tidswell

    Edward Tidswell

    Executive Director, Microbiology QA, Merck & Co, Inc.
    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode

    QC Lead iNeST Project (individualized Neoantigen Specific Therapy), Genentech, Inc
    Geeta Singh

    Geeta Singh

    Associate Site Director, Smartlabs
    James Polarine Jr

    James Polarine Jr

    Senior Technical Service Manager, STERIS Corporation
    Johannes Reich

    Johannes Reich

    Managing Director, Microcoat Biotechnologie GmbH
    Lori Daane

    Lori Daane

    Director of Scientific Affairs, bioMérieux, Inc
    Lynn Johnson

    Lynn Johnson

    Principal Scientist, Takeda
    Lynne Ensor

    Lynne Ensor

    Vice President, RCS Head of Global Compliance, Parexel International
    Morgan  Polen

    Morgan Polen

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

    Patrick-Julian Mester

    Postdoctoral Research Assistant, Institute of Food Safety, Food Technology and Veterinary Public Health, University of Veterinary Medicine, Vienna
    Rachael Relph

    Rachael Relph

    Chief Sustainability Officer, My Green Lab
    Ren-Yo Forng

    Ren-Yo Forng

    Scientific Director, Amgen
    Ruth Noé

    Ruth Noé

    Senior Product Manager, Lonza
    Scott Weiss

    Scott Weiss

    Director of Industrial Microbiology, Johnson & Johnson
    Stephen Langille

    Stephen Langille

    Senior Microbiologist Consultant, ValSource, LLC
    Timothy Wood

    Timothy Wood

    President and Principal Consultant, Cell Therapy Microbiology Consulting
    Veronika Wills

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod
    Ziva Abraham

    Ziva Abraham

    President, Microrite, Inc.

    Alison Laughlin

    Associate Director, Sterility Process Assurance - Aseptic, Boehringer Ingelheim Animal Health
    Alison Laughlin

    Alison Laughlin is the Associate Director of North America Regional Quality & Global Sterility Process Assurance for the Animal Health Division of Boehringer Ingelheim. She has over 25 years of technical expertise in sterility assurance, environmental monitoring, and microbiological testing of sterile pharmaceuticals, vaccines, and medical devices. Her expertise includes leading root cause investigations for complex microbiological issues and improving regulatory compliance and product quality. She currently develops divisional policies and procedures and provides quality support to the North America Boehringer Ingelheim Animal Health division sites and sterility assurance support to the global sites. Her prior roles included leadership positions in the Microbiology Laboratories at Baxter Healthcare, Hospira, and Wyeth. Alison holds a bachelor’s degree in Biology from Rutgers University, New Jersey.

    Arundhati Samanta

    Global Product Manager, Mettler Toledo
    Arundhati Samanta

    Arundhati Samanta is the Global Product Manager – 7000RMS Microbial Detection system since 2019. She is responsible for the product management of the analyzer along with related support products, accessories, and training. Arundhati has more than 10 years of experience in product and market management. She most recently was a Senior Product Manager for Thermo-Fisher Scientific. Prior to that, she held product and market management positions at Instrumentation Laboratory, Smiths Medical, and Conmed Endoscopic Technologies. Arundhati received her Bachelor’s Degree in English Literature and a Master’s Degree in Comparative Literature from India. She also has a Master’s Degree in Business (MBA) from Babson College of Business in MA.

    Brett Hoffmeister

    LAL Production Manager, Associates of Cape Cod, Inc.
    Brett Hoffmeister

    With over 17 years’ experience in LAL manufacturing, Brett is also ACC’s subject matter expert on horseshoe crab conservation and sustainability. Brett has worked to develop a number of critical sustainability initiatives at ACC, including ACC’s Horseshoe Crab Sustainability project. This exciting new program was launched in 2018 and has led to over 850,000 juvenile horseshoe crabs being released into coastal waters in Massachusetts. Brett works closely with fisherman, dealers and regulators in his role at ACC. In addition, he manages internships with several colleges and universities, is a member of the Bio-tech advisory Committee at Bristol Community college and serves as Chair to the horseshoe crab advisory panel of the Atlantic State Marine Fisheries Commission.

    Christine Massaro

    Director, Sterile and Microbiology Quality Assurance, Organon
    Christine Massaro

    Christine is a Director in the Global Sterile and Microbiology Quality Assurance group at Organon (formerly part of Merck). She currently supports global regulatory inspections regarding laboratory testing and develops divisional microbiological standards and procedures. She has expertise in microbiological laboratory testing, global compendial compliance, non-sterile contamination prevention, and microbial control of aseptic processing.
    Prior to joining Merck in 2017, she spent time at Johnson and Johnson and Medtronic overseeing external contract laboratories, CMO microbiological testing, supporting manufacturing and laboratory investigations, and performing non-sterile microbiological site risk assessments.
    Christine has earned her B.S in Biology and an M.S. degree in Microbiology from Wagner College, Staten Island NY.
     

    Don Singer

    Chair, General Chapters - Microbiology Expert Committee, US Pharmacopoeia
    Don Singer

    Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member of this committee since 2000. Don is a member of the European Pharmacopeia Group 1 Microbiology Committee. He is also chair of the PDA Task Force for the revision of Technical Report titled, “Pharmaceutical Package Integrity Testing”, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is also an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

    Edward Tidswell

    Executive Director, Microbiology QA, Merck & Co, Inc.
    Edward Tidswell

    Edward C. Tidswell, BSc, PhD - Dr. Tidswell is Executive Director within the Sterile and Microbiology QA organization of Merck with ownership over sterility assurance and microbiology issues across sterile and non-sterile sites. His prior appointments include global R&D, and quality leadership roles across diverse drug, device and biologics portfolios for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing. Currently a member of the PDA Journal’s Editorial Board, and since June 2010 Dr. Tidswell has served on the USP Expert Committee for Microbiology.

     

    Friedrich von Wintzingerode

    QC Lead iNeST Project (individualized Neoantigen Specific Therapy), Genentech, Inc
    Friedrich von  Wintzingerode

    Friedrich is QC Lead of the iNeST Project (individualized Neoantigen Specific Therapy) at Roche-Genentech.
    After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany.
    He joined Roche in 2001 working as QC Manager and Senior QC Manager on various topics (environmental monitoring, cleaning analytics, microbiological IPC and analytics for release).
    Friedrich led several Roche-Genentech expert teams (e.g. identification, microbiological testing, endotoxin testing, and Low Endotoxin Recovery/LER) and co-chaired the PDA Low Endotoxin Recovery Task Force, which authored PDA Technical Report No 82 on LER. He is also a member of the PDA ATMP advisory board.

     

    Geeta Singh

    Associate Site Director, Smartlabs
    Geeta Singh

    Geeta Singh, recently joined SmartLabs as an Associate Site Director. Geeta brings 20 years of experience as Sr. Technical Specialist/Group Leader in Biopharma Technical Development, at Genentech, Inc. A Member of Roche Group. She has experience in both mammalian and bacterial cell culture from lab to manufacturing with focus on evaluating and implementing new technologies to enable efficient process development and technical transfers across Roche sites. In addition to coordinating complex experiments for process development, Geeta played a critical role as a Group Leader responsible for establishing and managing microbial and in-process monitoring quality control programs in the premier pilot plant facility. Geeta holds an MBA from St. Mary’s College of California, BS in Business Administration from Notre Dame De Namur University and Diploma in Biotechnology, Clinical Trial Design & 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.

    Johannes Reich

    Managing Director, Microcoat Biotechnologie GmbH
    Johannes Reich

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

    Lori Daane

    Director of Scientific Affairs, bioMérieux, Inc
    Lori Daane

    Lori Daane is the Director of Scientific Affairs at bioMérieux and has over 30 years’ experience in clinical, environmental and industrial microbiology. She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development. Lori received her Ph.D. from the University of Minnesota in Microbial Ecology and performed postdoctoral research at Rutgers University and Los Alamos National Laboratory. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.

    Lynn Johnson

    Principal 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, RCS Head of Global Compliance, 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.

    Morgan Polen

    SME, Cleanroom Contamination Control 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, Institute of Food Safety, Food Technology and Veterinary Public Health, 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.

    Ren-Yo Forng

    Scientific Director, Amgen
    Ren-Yo Forng

    Ren-Yo Forng joined Amgen in 2015 as the Scientific Director of Microbiology in Process Development organization. His working experiences included research in microbiology and virology as well as manufacturing technical support and quality organizations in Bristol-Myers Squibb and AstraZeneca Biologics. Ren-Yo holds M.S. and Ph.D. degrees from the Laboratory of Microbial and Biochemical Sciences program from Georgia State University. He leads the effort in evaluation of innovative microbiological technologies, development and improvement of methods, and developing microbial control strategies in his role. Additionally, he supports subjects associated with manufacturing of drug substances and drug products where microbiology expertise or guidance is needed.

    Ruth Noé

    Senior Product Manager, Lonza
    Ruth Noé

    Ruth Noé is Senior Product Manager for Lonza Bioscience supporting Bacterial Endotoxin Automation and Software products. She joined Lonza in 2001 as a Product Specialist and later transitioned through roles in Sales Management and Product Support before commencing in her current role. Prior to Lonza, Ruth was a Business Development Manager for Covance Laboratories working with the Biotechnology team. Previous employments were laboratory based using RT-PCR in predicting Neuroblastoma relapse in children for the Candlelighter’s Laboratory at St James’ Hospital Leeds UK and in virology diagnostics for Public Health Laboratories UK.

    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.

    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.

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod
    Veronika Wills

    Veronika has over 13 years experience in endotoxin testing, and currently manages the global technical team at ACC and is based at ACC’s US Headquarters in East Falmouth, Massachusetts . Veronika is a subject matter expert when it comes to endotoxin testing and often provides expert sessions at global events focused on BET products and processes. Most recently Veronika has been speaking on the topic of recombinant technology as it relates to BET in the industry and abroad. Veronika is a key contributor to ACC’s sustainability initiatives and spokesperson on ACCs related projects, products and services.

    Ziva Abraham

    President, 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

    Official Media Partner

    Supporters

    Workshops

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Preliminary Attendee List

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    Sponsor Speaker Interview - Ruth Noe, Lonza

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    Speaker Interview Lynn Johnson

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    Speaker Interview Christine Massaro Organon

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    NEW Updated Pharmaceutical Micrbiology West Coast Brochure

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    Co-Chairs Invite Letter to Pharmaceutical Microbiology West Coast Conference 2021

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    Conference Two Day Program 2021

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    Conference Speakers 2021

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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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    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.


    Lonza

    Sponsors
    http://bioscience.lonza.com

    Lonza is the trusted QC testing solution provider for the pharmaceutical and medical device industries. Lonza offers fully integrated software solutions and products for quantitative endotoxin detection, whether traditional, sustainable or automated methods are needed. Lonza transforms its practical knowledge and technical expertise to deliver a portfolio of endotoxin detection products and paperless QC microbiology, software and services that support the critical needs of regulated manufacturing environments.


    METTLER TOLEDO

    Sponsors
    http://www.mt.com

    Mettler-Toledo Process Analytics is a leader in process and pure water monitoring instrumentation used in pharmaceutical and biotech applications, specializing in process control measurements for regulated water systems. These on line risk reduction tools include Total Organic Carbon Sensors, Real Time Microbial Analyzers and in line Conductivity/Resistivity Sensors, all required measurements for pharmaceutical waters. METTLER TOLEDO's innovation continues with the availability of the 7000RMS analyzer for on-line microbial monitoring.


    Microcoat

    Sponsors
    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.


    Media Partners


    Genetic Engineering News

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

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


    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.


    Labcompare

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

    Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


    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


    Rapid Microbiology.com

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

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


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.

    Media Partners


    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!


    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.


    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


    EIN News

    Supporters
    http://www.einnews.com

    EIN News is the world leader in industry focused online news monitoring. Thousands of leading companies, institutions and global professionals from business, industry, and government rely on EIN News as an indispensable resource. Our systems continuously scan the web, indexing news from thousands of worldwide sources. The news you need is then organized by advanced software systems managed by a team of professional news editors. Everything we do is focused on streamlining your news searches and research in order to save you time and money.


    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.


    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


    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.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

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


    IBI - International Biopharmaceutical Industry

    Supporters
    http://www.biopharmaceuticalmedia.com

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


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    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.


    Hospital & Healthcare Management

    Supporters
    https://www.hhmglobal.com/media-pack



    Select Science

    Supporters
    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.

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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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