SMi proudly presents the 2nd Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on the 7th and 8th of June 2018.
The pharmaceutical microbiology field is an ever-present constant in almost all areas of pharmaceuticals.Therefore, professionals within the field need to be informed and updated on the revised regulations and newly emerging methods and practices.

Join us to discuss and address the evolving issues facing this industry, such as: the aseptic practice and contamination prevention, mycoplasma testing, water monitoring and biofilms.

  • Take part in informative and valuable discussions about the best practices to circumvent common laboratory issues
  • Gain insight into successfully implemented new methods, through case study presentations
  • Interact with industry experts and benefit from valuable networking opportunities
  • Become updated on the most cutting edge microbial methods and rapid detection methods and learn how to successfully implement them within your own laboratory
  • CPD Certified: Continuing professional development (CPD) is a commitment by members to continually update their skills and knowledge in order to remain professionally competent. You can gain CPD points by attending our events!

Advanced Sterilization Products (J&J); Aequor Inc; Ajinomoto Althea Inc.; Allergan; Amgen; AntriaBio; B. Braun Medical Inc.; Battelle Memorial Institute; Baxter Healthcare Corporation; BGH International; Bimeda; Bimeda Inc.; Biomerieux; Cenexi; Charles River; Copan Diagnostics Inc; Excellent Pharma Consulting Inc; Genentech; Genentech Inc; Genentech, Inc.; Genzyme ; Global Drug Development Consulting; GSK; Janssen; JD Technologies, LLC; Microbiologics; Microrite; Millipore Sigma; Nipro PharmaPackaging; Pacira Pharmaceuticals Inc; PSC Biotech; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals Inc.; Renaissance Pharma; Sanofi Pasteur; Shire plc; STERIS Corporation; Steri-Tek; University of California San Diego; University of Salford;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Ziva Abraham

Ziva Abraham, Founder and CEO, Microrite

9:10 The arising issues with environmental monitoring following the implementation of more advanced monitoring equipment

Ron Smith

Ron Smith, Director, External Supply Integration Quality, Janssen

  • New technology that has been implemented into monitoring techniques
  • The impact of these new technologies e.g. the improved biocounts that new technology can measure of new microbes
  • The monitoring issues which arise due to the implementation of these new technologies
  • Strategic monitoring methods to establish exactly where the contamination is coming from
  • 9:50 Rapid microbial methods – a case study of implementation

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • The implementation of rapid methods in practice, how best to adopt these new methods and keep up with developments
  • Validating the methods and conforming to regulatory requirements
  • The issues surrounding the implementation of rapid methods and how to overcome them
  • How to best tailor your implementation proposal in terms of validation of your rapid method
  • 10:30 Morning Coffee

    11:00 BET testing: strategies for testing difficult samples

    Veronika Wills

    Veronika Wills, Technical Services Specialist, Associates of Cape Cod

  • A short overview of the Bacterial Endotoxin Test methodology
  • Potential interactions between the matrix and assay components rendering the samples difficult to test
  • Strategies by sample type
  • Presenting a case study

    11:40 Changing a Paradigm: Developing a Roadmap to implementing a Real Time Microbial Detection Analyzer in Pharmaceutical Water

    Mike Russ

    Mike Russ, Manager, QC Microbiology, Genentech Inc

  • Evaluating the potential for comparing Auto Fluorescent Units (AFU) to Colony Forming Units (CFU)
  • Discuss results of a study that evaluated the 7000RMS in a GMP Water for Injection system
  • Setting alert and action limits
  • Detail next steps: evaluation phase to implementation
  • 12:20 Networking Lunch

    13:30 Strain Typing: A valuable tool for tracking microbial contamination

    Bindhu Verghese

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

  • Overview of microbial identification methods
  • Assessment of identification platforms for species to strain-level characterization
  • Utility of microbial strain typing in the pharmaceutical industry
  • Tracking strains - Case studies
  • 14:10 Introduction to a Global Disinfectant Efficacy Study Approach

    Lisa Yan

    Lisa Yan, Principal Quality Laboratory Associate, Shire plc

  • Leveraging multi-site data within a company
  • Selection of representative surfaces and environmental in-house isolates
  • Developing a Global disinfectant efficacy study: Considerations and Challenges

    14:50 Afternoon Tea

    15:20 Underlying issues behind microbiological data deviations and data integrity

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

  • Microbiological data deviations, investigations and data integrity related FDA observations are on the rise throughout the pharmaceutical arena. Any of these deficiencies can be avoided with a contamination control mind-set from the get go
  • Microbiological data deviations occur due to many reasons; inadequate facility, barrier design and airflows visualization studies. inadequate process/laboratory controls, lack of understanding of gowning and cleaning are also a factor. Case studies to demonstrate this
  • Main reasons for deviant EM data and data integrity


  • 16:20 Aseptic processing in manufacturing

    William Fleming

    William Fleming, Chief Consultant, GXP Consultants Inc

  • The current struggles and issues with upholding aseptic manufacturing processes and practices
  • Cross-contamination considerations that need to be taken into account during manufacturing processes
  • Contamination in bioprocessing equipment
  • Containment strategies that can be used to circumvent these issues – which methods would be the best for you?


  • 16:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

    9:10 An update on the restructuring of the FDA inspection structure

    David Hussong

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

  • The re-organisation of the FDA inspection structure
  • What impact this would have upon your regulatory inspections – would routine inspections be affected?
  • Does this re-organisation come with any updated regulatory expectations?
  • How the re-organisation would affect the biotech industry
  • 9:50 Combining genetics with traditional methods to increase accuracy in microbial ID

    Elia Sanchez

    Elia Sanchez, QC Microbiology Sr. Manager, Genentech

  • Summary of the Genetic Analysis Technology
  • Bacterial ID vs Fungi ID
  • Exceptions to the rules
  • Traditional methods (Back to the basics case studies)
  • 10:30 Morning Coffee

    11:00 Controversies and questions about non-sterile bioburden testing

    Heidi Anderson

    Heidi Anderson, Principal Scientist, Microbiology, Abbott Laboratories

  • Bioburden testing and monitoring for the non-sterile manufacturer
  • Establishing a microbiological testing program that makes sense for your product
  • How to manage challenges, controversies and questions about non-sterile bioburden testing
  • 11:40 Fungal and bacterial spore excursions in cleanrooms – case studies

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

  • The industry has seen an increase in the number and species of bacterial endospores and mold spores found in many facilities.  This presentation will focus on ways to proactively limit bacterial and mold spore contamination from incoming items into cleanrooms and limit other sources of spore contamination.
  • Current industry regulations in the US and Europe will be discussed related to sporicides and disinfectants.  Additionally, the presentation will convey a robust approach to addressing bacterial and fungal spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species such as Bacillus cereus.
  • New and recent case studies will be covered which focus on new antimicrobial chemistries and their performance against fungal and bacterial spores in cleanrooms.  The attendees will ascertain a better approach to root causes and determining sources of spore contamination in their cleanroom and controlled facilities.



  • 12:20 Networking Lunch

    13:30 The background and implementation of mycoplasma testing

    Meghan May

    Meghan May, Associate Professor of Biomedical Sciences, Microbiology and Infectious Disease, University of New England

  • The PCR approach of mycoplasma testing vs the growth method – what are the similarities and differences between the two approaches?
  • The conceptual backing behind mycoplasma testing – what the test is hoping to achieve
  • Should rapid in-house testing be favoured or contract manufacturing or the test?
  • 14:10 How rapid mycoplasma safety testing could revolutionise quality control and lot release in biopharmaceutical manufacturing

    Renate Rosengarten

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

  • Safety issues - why are mycoplasmas of major concern in biopharmaceutical processes
  • Regulatory overview for mycoplasma testing
  • Current trend towards automated PCR-based in-process control and lot release mycoplasma testing
  • Product-specific multi-step mycoplasma PCR validation concepts 


  • 14:50 Afternoon Tea

    15:20 New thinking about facility cleaning and sanitisation

    Dilip Ashtekar

    Dilip Ashtekar, Senior Director, Sterility Assurance, Intarcia Therapeutics

  • Differences between facility cleaning and sanitization and between in-vitro and in-situ disinfectant qualification
  • Best practices for facility cleaning and disinfectant qualification and myths about disinfectant qualification
  • Best practices for preventing contamination due to facility cleaning and sanitization
  • Data integrity aspects related to facility sanitization program and disinfectant qualification and facility surveillance programs


  • 16:00 How the technologies in pharmaceutical microbiology could be applied, utilised and translated into other fields

    Shahram Lavasani

    Shahram Lavasani, CEO, ImmuneBiotech AB

  • Case studies to show that the human microbiome is affected by large amounts of environmental influences e.g. chemicals released into the environment could end up in the water systems
  • As such, water microbial detection techniques and environmental monitoring equipment could be used and applied to human biology
  • How technology used in pharmaceutical microbiology could be developed and applied to human diagnostics e.g. quick diagnostic testing derived from RMM
  • 16:40 Chairman’s Closing Remarks and Close of Day Two


    Sponsors and Exhibitors

    Official Media Partner



    Technologies for Microbial Contamination Control

    Technologies for Microbial Contamination Control

    Crowne Plaza San Diego - Mission Valley
    6th June 2018
    San Diego, USA


    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North, San Diego, CA, USA

    Invite from the Chair - Ziva Abraham


    2017 Post Event Infographic - Pharma Microbiology West Coast


    Updated Brochure Download


    Sponsor insight - Press Release


    Past Attendee List


    Sponsors and Exhibitors

    Associates of Cape Cod, Inc.

    Sponsors and Exhibitors

    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.


    Sponsors and Exhibitors

    Like you, we are inquisitive microbiologists who rely on our experience to explore and innovate ways to keep your lab running smoothly and ensure that your products are safe. Visit www.thepeoplebehindthescience.com to see what new science our people are creating for you. Together, we are the people behind the science.

    Charles River

    Sponsors and Exhibitors

    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.

    Fujifilm Wako

    Sponsors and Exhibitors

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

    Roche CustomBiotech

    Sponsors and Exhibitors

    Building on decades of experience as a diagnostics and pharmaceutical manufacturer, Roche CustomBiotech offers a broad range of innovative products and services for in vitro diagnostics, biopharmaceuticals, and cell and gene therapy markets. Some specific product categories include enzymes, high resolution cell counter, robust and reliable photometric-based bioanalyzers, and rapid PCR-based quality control assays for in-process testing and product release. With our extensive industry experience and strong customer orientation, Custom Biotech is committed to helping you achieve success across all stages of the development process.

    Media Partners

    Rapid Microbiology.com

    Official Media Partner

    rapidmicrobiology.com - keep up-to-date with all the latest products for your pharmaceutical microbiology laboratory, subscribe to the rapidmicrobiology.com newsletter http://www.rapidmicrobiology.com/Newsletter.php

    Technology Networks

    Official Media Partner

    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

    Colorado Bioscience

    Official Media Partner

    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.

    American Pharmaceutical Review

    Official Media Partner

    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

    Media Partners

    European Pharmaceutical Review


    European Pharmaceutical Review is the leading bi-monthly technical journal for the pharmaceutical industry, and essential reading for anyone involved in drug discovery or manufacturing. Every issue offers a high level of technical and business contributions from the world's leading pharmaceutical companies and academic institutions, keeping readers up-to-date with new developments and projects within the dynamic European pharmaceutical environment and featuring articles on topics that impact the sector, including: – cellular imaging, drug discovery, microbiology, stem cells and toxicology. The strength of European Pharmaceutical Review is reflected by our circulation figures, with an estimated 30,000 readers across the globe.



    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.

    Drug Discovery Today


    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.



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



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



    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.



    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 Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

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    Swiss Biotech Association


    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.

    MDPI Biology Journal


    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).

    Drug Target Review


    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.



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



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



    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.

    Inderscience Publishers


    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.



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



    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.



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


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    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North
    San Diego 92108

    Crowne Plaza San Diego - Mission Valley



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    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.


    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.


    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.


    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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