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SMi’s 2nd Annual Conference
Next Generation Pharmaceutical Cleanroom
October 6-7, 2021 | London
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SMi proudly presents the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference.

It is a critical time for cleanrooms as new regulations in Good Manufacturing Practice enter their final drafts after several months in review. This stringent regulatory framework is driving the Cleanroom market  to surpass GBP £5 billion in value by 2025, alongside the COVID-19 crisis, which has made it imperative for the pharmaceutical industry to follow cleanroom protocols. This industry is also seeing remarkable developments in its technologies, including novel capabilities in robotics and automation as well as the new procedures required when manufacturing Advanced Therapy Medicinal Products.

Join us in October, when this conference will explore the latest schools of thought in the cleanroom industry, from operator management and environmental monitoring, to breakthroughs in the future of cleanroom design and Contamination Control Strategy.


We look forward to welcoming you to the conference in October.
 

Join us in addressing the challenges in the next generation of cleanroom technology and engineering by bridging the gap and sparking conversations:

  • GAIN insight into the revised regulations and new standards, from EN 17141 to EU Annex 1 GMP
  • EXAMINE the changes to Annex 1 and strategies of Environmental Monitoring Program implementation with Sanofi and Merck
  • EXPLORE the challenges of creating cleanrooms fit for purpose and qualifying automated filling lines
  • UNCOVER the effective risk-based approaches in cleanroom verification and cleaning monitoring
  • DISCUSS the advantages of robotics in cleanrooms and the automated cleanroom of the future
  • JOIN the in-depth panel on the latest regulatory standards and the impact of the pandemic on the industry 
     

 

 

Heads, Managers, Directors, Experts:

  • Microbe Monitoring
  • Contamination control
  • Aseptic Processing
  • Cleanroom Technology
  • Microbiology
  • Sterility Assurance
  • Environmental Monitoring
  • Operator Management

3dimension Cleanrooms Limited; ALK-Abello Nordic A/S; Allergan Biologics Ltd; Alpha RLH; ASCCA (Italian Cleanroom Society); AstraZeneca; Baxter Healthcare Ltd; Bio Products Laboratory Ltd; BIOMÉRIEUX AUSTRIA GMBH; BioTekPro AB; Boehringer Ingelheim; Boehringer Ingelheim Animal health; Charles River EMD; Contec; Contec Inc; Contec Incorporated; DEERNS S.L; Dupont De Nemours (Luxembourg) S A; Ecolab; EECO2 Ltd; Fresenius Kabi; Fresenius Kabi Product Partnering ; Fresenius Kabi UK Ltd; GSK; Imperial College London; Kings College London; MeiraGTx; PHSS: Pharmaceutical & Healthcare Sciences Society; Porton Biopharma Limited; Porton Biopharma Ltd; Royal Free London NHS Trust; STERIS Corporation; Takeda; Techniconsult Firenze SRL; VCCN;

Conference programme

8:00 Registration & Coffee

9:00 Chair's Opening Remarks

Matts Ramstorp

Matts Ramstorp, CEO & Founder, BioTekPro AB
View Bio

9:10 Establishing a demonstrable contamination control strategy

Tim Sandle

Tim Sandle, Bio Banking Operations, Bio Products Laboratory

• Highlighting the commonly overlooked aspects in CCS implementation
• Avoiding reliance on microbiological testing for effective product sterility assurance
• Assessing, acknowledging, and remediating contamination risks
• The advances in metagenomics and rising concerns in contamination assessment
 

9:50 Reducing environmental monitoring excursions in a manufacturing environment

Dawn Tavalsky

Dawn Tavalsky, Senior Director Global Sterility Assurance, Sanofi Pasteur
View Bio

• Addressing issues in operator behaviour to minimise excursions in cleanrooms
• Capitalising on total-site coverage of environmental monitoring
• Implementing a gold standard strategy for contamination control
• Sustaining an effective environmental monitoring program
 

10:30 Morning Coffee

11:00 Introducing robots in bioprocessing environments: opportunities and outlook

Nikolaos Papakostas

Nikolaos Papakostas, Associate Professor, Director, Lab for Advanced Manufacturing Simulation and Robotics, University College Dublin
View Bio

• Bioprocessing industry: pressure for more automation
• Robots in bioprocessing environments: current status
• Opportunities for introducing mobile platforms and collaborative robots in medical device manufacturing and pharmaceutical production processes
• Application in environmental sampling processes
• Challenges and outlook
 

11:40 Panel Discussion: Implementing robotics and automation in biomanufacturing

As it stands the current layout of  bioprocess facilities demand require disproportionate levels of manual labour, and these  high labour costs drive up total cost to supply. From the managing of the raw materials to the processing itself, on top of product distribution, the biomanufacturing industry single-handedly invests the greatest proportion of its capital into labour over any other in the world. Now, as advanced automation technologies becoming increasingly available, robotics hold great potential to diminish these costs.

  • Current industry overview and the need for increased automation
  • GMP Requirements for the use of Robotics
  • What needs to be changed to have in the future fully automated facilities
  • Advantages of robotics in the pharmaceutical production process: from filling and packing to automated inspections
  • Homing in on the opportunities for modern robotics in the industry, and key challenges in their implementation
  • Future outlook: how collaborating co-bots are the best fit for biomanufacturing 
     
  • Nikolaos Papakostas

    Nikolaos Papakostas, Associate Professor, Director, Lab for Advanced Manufacturing Simulation and Robotics, University College Dublin
    View Bio

    Joseph McCall

    Joseph McCall, Associate Director, QA Technical Service , ADMA Biologics
    View Bio

    Richard Denk

    Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
    View Bio

    12:20 Contamination Control Strategy; A proposed roadmap

    Walid El Azab

    Walid El Azab, Senior Manager Technical Services , Steris Corporation
    View Bio

    • Formulate a Contamination Control Strategy (CCS)
    • Implement the CCS and develop a strategic plan to make the strategy work as intended
    • Evaluate the CCS efficiency to ensure process performance and product quality while improving the CCS level over time
     

    13:00 Networking Lunch

    14:00 Applying QRM for integrated EM as part of a Contamination Control Strategy and Annex 1

    Conor Murray

    Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
    View Bio

    • Principles of establishing control and then demonstrating control, aligned to Annex 1
    • Application of the new EN 17141 on biocontamination control to Viable EM
    • Application of ISO 14644-2:2015 to Non-Viable EM
    • QRM and choosing the most appropriate locations
    • Intelligent decision making based on the EM data
     

    14:40 Insight into the revised regulation: Annex 1 focused on Barrier Systems like Isolators

    Richard Denk

    Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
    View Bio

    • Reflection on the revision process for Barrier Systems
    • Benefits & challenges of the revised regulation
    • Concept for a globally harmonized CCS documentation concept
    • Outlook from a consultant’s perspective
     

    15:20 Application of the new EN 17141 on biocontamination control and of the new GMP Annex 1 draft to viable air monitoring

    Sabine Bessieres Recasens

    Sabine Bessieres Recasens, Field Marketing Manager BioMonitoring Life Science, Merck
    View Bio

    • Microbial measurement method (sampling method choice, volumetric air sampler, culture media)
    • Guidance on culture based microbiological methods and sampler verification
    • Guidance for life science applications
     

    16:00 Afternoon Tea

    16:30 Applying ISO14644-3:2019 to verify your cleanroom

    Stephen Ward

    Stephen Ward, General Secretary, Contamination Control Network
    View Bio

    • Care during design and construction to ensure cleanroom testability
    • Selecting appropriate tests and acceptance criteria
    • Application of test methods
    • Relationship with Annex 1
     

    17:10 Contamination control of microbe-carrying particles

    Koos Agricola

    Koos Agricola, Contamination Control Expert, VCCN/Brookhuis Applied Data Intelligence
    View Bio

    • Mechanisms of contamination by microorganisms
    • Contamination control solutions
    • Establish control by cleanroom ventilation and operational procedures
    • Demonstrate control by monitoring air cleanliness and particle deposition rate
    • ISO 14644-17:2021 Particle deposition rate applications
     

    17:50 Chair’s Closing Remarks and Close of Day One

    Matts Ramstorp

    Matts Ramstorp, CEO & Founder, BioTekPro AB
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Matts Ramstorp

    Matts Ramstorp, CEO & Founder, BioTekPro AB
    View Bio

    9:10 Cleanroom Operators – Still a major potential risk

    Matts Ramstorp

    Matts Ramstorp, CEO & Founder, BioTekPro AB
    View Bio

    • Cleanroom operators – Needed or not?
    • Know how – Know why!
    • Operator failures due to lack of knowledge
    • Cleanroom garment demands
    • Integrity testing of cleanroom garments
     

    9:50 Overview of Recommended Practices for Residue Removal in Cleanrooms

    Beth Kroeger-Fahnestock

    Beth Kroeger-Fahnestock, Technical Services, Steris Corporation
    View Bio

    • Regulatory and GMP expectations
    • Types of residues – Conditions leading to, typical components in disinfectants, residues on various substrates
    • Program recommendations
     

    10:30 Phase III: Performance Qualifi cation of the Disinfection Regime

    Helen Gates

    Helen Gates, Global Technical Consultant, Ecolab

    • A review of the final phase of implementation of a cleaning and disinfection regime; the performance qualification phase, also referred to as Phase III or in-situ field studies.
    • The purpose of this phase is to demonstrate the effectiveness of a cleaning and disinfection regime once it is in use within the facility, through the generation of data.
    • The presentation will outline possible structures to a Phase III program, how to handle the data generated and how to capitalise on the study to address other elements of a cleaning and disinfection regime, such as residue management and surface deterioration.

    11:10 Morning Coffee

    11:40 Cleanroom DeepTraining – possibilities and frontiers of Virtual Reality

    Sebastian Scheler

    Sebastian Scheler, Chief Methodologist and Co-Founder, Innerspace GmbH
    View Bio

    • VR-Training-concepts for mission critical activities and processes
    • Benefits of cleanroom simulators for enhanced training effect for aseptic operators
    • How to find training application fields for VR simulators with high scalability
    • Individualized vs Standardized trainings - a contradiction?
     

    12:20 Case Study: Expediting Mold Contamination Investigations with the Use of Biofluorescent Particle Counting Technology

    Dawn Watson

    Dawn Watson, Director – Microbial Control, MSD
    View Bio

    • This presentation will provide an overview of the rapid microbiological technology used, specifically BFPC
    • It will provide a case study for the application of BFPC technology to support mold remediation in an aseptic processing facility
    • The presentation will review the benefits and outcomes yielded with use of the BFPC technology to support resolution of an investigation
    • The presentation will provide opportunities for additional use of the BFPC technology to ensure successful return to operation following major shutdowns, facility modifications or breaches
     

    13:00 Risk-based approaches in cleaning monitoring

    Fred Ohsiek

    Fred Ohsiek, Senior Specialist, Cleaning Validation, Novo Nordisk
    View Bio

    • Overview of FDA 2011 Continued Process Verification (CPV) regulatory guidelines
    • Industry cleaning monitoring CPV practice and pitfalls
    • Cleaning monitoring CPV risk assessment approach and evaluation method
    • Case study for determining CPV frequency and testing type
     

    13:40 Networking lunch

    14:40 Panel Discussion: Regulatory Outlook and impact of the pandemic

  • Annex 1 – Interpreting changes & Implementation strategies
  • Application of the new EN 17141 to GMP: contamination control and EM
  • Breaking-down key ISO standards for the classification and monitoring of GMP cleanrooms
  • EU GMP Part IV - GMP requirements for Advanced Therapy Medicinal Products - Challenges in GMPs for short shelf-life products
  • Adopting paperless manufacturing, robust data integrity, and avoiding regulatory issues
  • How the COVID-19 pandemic has impacted the regulation
     
  • Tim Sandle

    Tim Sandle, Bio Banking Operations, Bio Products Laboratory

    Conor Murray

    Conor Murray, Principal Consultant, 3dimension Cleanrooms Limited
    View Bio

    Richard Denk

    Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
    View Bio

    Benoit Ramond

    Benoit Ramond , Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    15:20 Challenges of creating cleanrooms fit for purpose

    Patrizia Muscas

    Patrizia Muscas, Quality Assurance and Sterility Assurance New Line Project Manager, Eli Lilly Italia SpA
    View Bio

    • How to balance GMP compliance with facility implementation
    • Designing facilities to reduce costs and comply with GMP
    • Maximising preparation for Annex 1 final draft to measure and mitigate risk in cleanroom design
    • Implementing novel barrier technologies in legacy facilities for effective compliance with Annex 1

    16:00 Afternoon Tea

    16:30 Annex 1 – Changes & Implementation Strategy Concerning Environmental Monitoring Program

    Benoit Ramond

    Benoit Ramond , Head of Microbiology & Sterile Technology, Sanofi
    View Bio

    • Introduction with contamination control
    • Qualification of cleanrooms & barrier technologies
    • Sampling plan program justifications
    • Environmental monitoring non-viable particles
    • Environmental and personnel monitoring viable particles
     

    17:10 Removing the risk – experiences in qualification of a fully robotic isolator for aseptic filling of sterile drug product

    Joseph McCall

    Joseph McCall, Associate Director, QA Technical Service , ADMA Biologics
    View Bio

    • Case Study on commissioning of a new aseptic fill line – comparing conventional aseptic filling systems to the next-gen gloveless isolators
    • Customer experience – insights on moving to fully enclosed robotic isolators
    • Contamination Control – What it means to remove the Fill Room Operator
    • Industry Impact - Agility and Next Steps to the future of aseptic filling
     

    17:50 Chair’s Closing Remarks and Close of Day Two

    Matts Ramstorp

    Matts Ramstorp, CEO & Founder, BioTekPro AB
    View Bio

    +

    FEATURED SPEAKERS

    Benoit Ramond

    Benoit Ramond

    Head of Microbiology & Sterile Technology, Sanofi
    Beth Kroeger-Fahnestock

    Beth Kroeger-Fahnestock

    Technical Services, Steris Corporation
    Conor Murray

    Conor Murray

    Principal Consultant, 3dimension Cleanrooms Limited
    Dawn Tavalsky

    Dawn Tavalsky

    Senior Director Global Sterility Assurance, Sanofi Pasteur
    Dawn Watson

    Dawn Watson

    Director – Microbial Control, MSD
    Francesca  Burberi

    Francesca Burberi

    Technical Service and Manufacturing Science Senior Manager, Eli Lilly Italia SpA
    Fred Ohsiek

    Fred Ohsiek

    Senior Specialist, Cleaning Validation, Novo Nordisk
    Helen Gates

    Helen Gates

    Global Technical Consultant, Ecolab
    Joseph McCall

    Joseph McCall

    Associate Director, QA Technical Service , ADMA Biologics
    Koos Agricola

    Koos Agricola

    Contamination Control Expert, VCCN/Brookhuis Applied Data Intelligence
    Matts Ramstorp

    Matts Ramstorp

    CEO & Founder, BioTekPro AB
    Nikolaos Papakostas

    Nikolaos Papakostas

    Associate Professor, Director, Lab for Advanced Manufacturing Simulation and Robotics, University College Dublin
    Patrizia Muscas

    Patrizia Muscas

    Quality Assurance and Sterility Assurance New Line Project Manager, Eli Lilly Italia SpA
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Sebastian Scheler

    Sebastian Scheler

    Chief Methodologist and Co-Founder, Innerspace GmbH
    Stephen Ward

    Stephen Ward

    General Secretary, Contamination Control Network
    Tim Sandle

    Tim Sandle

    Bio Banking Operations, Bio Products Laboratory
    Walid El Azab

    Walid El Azab

    Senior Manager Technical Services , Steris Corporation

    Benoit Ramond

    Head of Microbiology & Sterile Technology, Sanofi
    Benoit Ramond

    Benoît Ramond is Doctor in Pharmacy at the University of Paris XI in France and obtains a PhD in Microbiology.
    He has more than 30 years of experiences in the Pharmaceutical Industry.
    Since 2016 he is Head of Microbiology and Sterile Technology Expertise in Sanofi Group. In his function he has also a leading role in the Annex 1 implementation program within Sanofi.
     

    Benoit Ramond

    Head of Microbiology & Sterile Technology, Sanofi
    Benoit Ramond

    Beth Kroeger-Fahnestock

    Technical Services, Steris Corporation
    Beth Kroeger-Fahnestock

    <p>Beth Kroeger is a Technical Services Senior Manager for STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics. Beth has over 25 year&rsquo;s industry experience in R&amp;D involving infectious diseases and Biopharmaceutical and Oral Solid Dose manufacturing operations. She earned a B.S. in Biochemistry from the University of Missouri, St. Louis and is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program for the Spring semester 2020. She is currently on the ISPE task force to draft Cleaning Validation Guidelines for Biopharmaceutical Operations.</p>

    Conor Murray

    Principal Consultant, 3dimension Cleanrooms Limited
    Conor Murray

    Conor Murray has over 30 years’ experience in design and construction of cleanrooms andbiosafety labs, and since 2007 independently in an oversight and auditing role.Conor represents the National Standards Authority of Ireland (NSAI), as Head of Delegation and a SME at ISO/TC209 and the European mirror CEN/TC243 on cleanroom standardisation. Conor is a past Convenor of CEN/TC243 WG-05 on biocontamination control and the recently published EN 17141 standard. Conor is the Chair of the Healthcare Services Committee advising the Irish Health Service Executive on standards compliance. Conor is Chair of the Irish Cleanrooms Society (ICS) and a past Chair of the International Confederation of Contamination Control Societies, (ICCCS). Conor lectures internationally and gives cleanroom training and education courses on behalf of the ICS.

    Dawn Tavalsky

    Senior Director Global Sterility Assurance, Sanofi Pasteur
    Dawn Tavalsky

    Ms. Tavalsky is a Senior Director of Global Quality with Sanofi Pasteur, the vaccine division of Sanofi. She has over 30 years of experience in the pharmaceutical industry including small molecule, device, biologics and vaccines. She is a Sterility Assurance and Validation subject matter expert.

    Dawn Watson

    Director – Microbial Control, MSD
    Dawn Watson

    Dawn is a Director supporting Microbial Control at MSD. She works in the Sterile & Validation Center of Excellence managing a team that leads and executes global initiatives targeted to proactively address quality and compliance risks in the sterile and low bioburden network while driving continuous improvement. Additionally, her team provides microbial contamination control and sterile manufacturing expertise to resolve critical production issues, develop innovative solutions, and ensure network alignment with industry and regulatory expectations. She is an active member in the Parenteral Drug Association and BioPhorum Operations Group. She has 26 years of experience in the pharmaceutical industry, specifically focused on sterile and low bioburden products including vaccines, therapeutic proteins and small molecules. She is trained and certified in Six Sigma and Change Management. She has held positions in validation, manufacturing and research and development throughout her career with MSD.

    Francesca Burberi

    Technical Service and Manufacturing Science Senior Manager, Eli Lilly Italia SpA
    Francesca  Burberi

    Francesca is responsible for keeping updated the annual projects agenda in the manufacturing plant in Sesto Fiorentino, Italy. As a Senior Consultant, she tracks the information that comes into the Project Management hub and makes sure everything is running smoothly. The broad function of the job is to ensure that site projects stay on track and on budget.
    She had several years of experience as responsible in Calibrations, Initial and Periodic Validations and Quality Systems. She had the responsibility of the qualification of the sterilization systems and the equipment calibrations, to maintain the validated state in the aseptic environment.
    She had years of experience in validation/ qualification/ quality system (i.e. Change Control and Deviations)/ cold chain management/ quality system (i.e. Change Control and Deviations) of refrigerated biotechnological products, in compliance with current regulations and practices.
     

    Fred Ohsiek

    Senior Specialist, Cleaning Validation, Novo Nordisk
    Fred Ohsiek

    Fred Ohsiek is the Sr Cleaning Validation Specialist for Novo Nordisk in Clayton, NC. He earned his Bachelor in Chemistry from University of South Florida. His professional work experience includes 7 years of R&D performing enzymatic digestion, ultrafiltration and fermentation on citrus peel while working for the USDA and over 20 years of cleaning validation while working for Catalent Pharma Solutions, Amylin Pharmaceuticals, Ben Venue Laboratories, Teva Pharmaceutical Industries, Astellas Pharma Technologies Bayer (biotech division), and Novo Nordisk. He was considered the cleaning validation subject matter expert in most positions held.
    His cleaning validation experience includes developing, validating, and monitoring cleaning processes for equipment used to manufacture small molecule [oral dose (solid and liquid) and parenteral], peptide hormone encased (parenteral), and large molecule (biotech) pharmaceutical, OTC, and nutritional products. The scope of his work involved API and finish product manufacturing start-up, remediation, legacy process justification, and increasing manufacturing capability. He has authored documents and executed in every aspect of the cleaning validation process.
    He has conducted risk assessments for determining cleaning monitoring frequency, validation scope, and dated cleaning validation packages.
    He has successfully defended cleaning validation documents and concepts (i.e., created and legacy) in several US and OUS regulatory audits.
     

    Helen Gates

    Global Technical Consultant, Ecolab
    Helen Gates

    Joseph McCall

    Associate Director, QA Technical Service , ADMA Biologics
    Joseph McCall

    Joe McCall, SM (NRCM) is the Associate Director of Quality Assurance Technical Services at ADMA Biologics in Boca Raton, FL. He has over 25 years of experience as a professional microbiologist at such companies as Bausch & Lomb, Genzyme, DSM Pharmaceuticals, STERIS Life Sciences, and Mass Biologics. Joe has been an active industry member throughout his career, teaching courses at PDA TRI, University of Tennessee HSC, and has presented at FDA CBER Division of Product Quality and Manufacturing. Joe has delivered training seminars in pharmaceutical microbiology and aseptic processing for companies and organizations in Europe, Asia, South America, and across the US. He is an ASQ Six Sigma Greenbelt and is one of only a handful of professionals to attain the designation of a Certified Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology by the American Society for Microbiology (ASM / NRCM).

    Koos Agricola

    Contamination Control Expert, VCCN/Brookhuis Applied Data Intelligence
    Koos Agricola

    Koos is an applied physicist with 34 years’ experience in contamination control and cleanroom technology. He is product manager and contamination control specialist at the Brookhuis Applied Data Intelligence Cleanroom division. He is also active in education and standards for cleanroom technology. He has been process engineer in the manufacturing of strategic materials and devices at R&D of Canon Production Printing (formerly Océ Technologies).
    He is an executive board member of ICCCS (International Confederation of Contamination Control Societies) and VCCN (Contamination Control Society of the Netherlands). He is convenor, delegate and expert in ISO TC209 and CEN TC243 and the development of the ISO 14644 and ISO 14698 standards. He has been treasurer and chairman of the CTCB-I (International Cleanroom Testing and Certification Board).
    He wrote various papers on the determination of requirements of cleanrooms, operational procedures and monitoring surface contamination.
     

    Matts Ramstorp

    CEO & Founder, BioTekPro AB
    Matts Ramstorp

    Matts Ramstorp has been working for more than 35 years with cleanliness and hygiene as a researcher, consultant, lecturer and educator. Matts has a Master of Science in Chemical Engineering, Technology, a PhD in Applied Biochemistry (Biotechnology) and became Professor in Contamination Control and Cleanroom technology at LTH, Lund University of Technology in 2002. Matts has also published several textbooks in the field of cleanroom technology.

    Nikolaos Papakostas

    Associate Professor, Director, Lab for Advanced Manufacturing Simulation and Robotics, University College Dublin
    Nikolaos Papakostas

    He is the Research Director of the Laboratory for Advanced Manufacturing Simulation and Robotics in the School of Mechanical and Materials Engineering at University College Dublin.
    His research areas include Robotics, Digital Manufacturing, Optimization of Manufacturing Systems and Networks. He has cooperated with many leading companies in Ireland and Europe mainly from the bioprocessing, automotive and aerospace industrial sectors as well as with top machine tool building and software firms. He has coordinated a significant number of European and national research projects targeting at the introduction of novel digital technologies in the manufacturing environment of the 21st century. He has authored more than 100 scientific papers with more than 2500 citations. He has been the IT Manager of a big manufacturing company for several years. He is a member of the International Academy for Production Engineering (CIRP).
     

    Patrizia Muscas

    Quality Assurance and Sterility Assurance New Line Project Manager, Eli Lilly Italia SpA
    Patrizia Muscas

    27 years of experience in Pharmaceutical and Biopharmaceutical field. Experience raised working with International Companies (GSK; Chiron Vaccine/Novartis; Eli Lilly).
    During these years of experience, I have been part of different teams involved in the validation and improvement of production sites for Sterile liquids, Dry powders, Vaccines, and non-sterile products. The skills required for the different positions covered has included: deep knowledge of Microbiology, Virology and Biotechnology; knowledge of all Microbiological, Biological and Immunological tests related to sterile drugs and vaccines as well as deep knowledge of applicable regulations including USP /EP /EMA/ISO/FDA cGMP’s. In the last 8 years my primary role was dedicated to oversight of all sterility assurance aspect/topics with regards to the Eli Lilly Sesto production lines (Isolator and RABS technology). I was part of the teams involved in the new construction of these new lines departments with responsibility for all Sterility Assurance topics/strategies and in particular on Isolator VPHP cycle and sterilization processes qualification/management. In the last years I covered the role of Leader of the team guarantying the oversight for all Sterility Assurance aspects of the Sesto Lilly parenteral site participating to all Global network activities on this topic. .From last year I joined the Global TS-MS Sterility Assurance group supporting and interacting with the Global Network teams for all the aspects related to Sterility Assurance , Environmental Monitoring and Contamination Control strategies.
     

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Richard Denk

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil, as a Senior Consultant in Aseptic Processing & Containment. Eleven years ago Richard founded the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard is also Chair of the ISPE Special Interest Group Robotic, Steering Committee Member of the CoP SPP Sterile Product Processing, Member of the ISPE Europe Leadership Team. Furthermore, a member of the PDA Isolator Expert Group and publisher of the PDA Scientific Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Richard is Member of the ISO TC 198 WG-9 Aseptic Processing of Health Care Products. Richard has spent beside aseptic processing more than 20 years with the production of highly active / highly hazardous substances and has developed the containment pyramid.

    Sabine Bessieres Recasens

    Field Marketing Manager BioMonitoring Life Science, Merck
    Sabine Bessieres Recasens

    Sabine Bessières- Recasens has Master’s degrees in human physiopathology (Pharmacy), Industrial microbiology, biochemistry Toulouse University. Work for Health Industry for twenty-five years in Life Science Product Management. In the Marketing BioMonitoring Europe Merck Life Science, I lead the microbiology portfolio of Environmental Monitoring for Pharmaceuticals cleanrooms or isolators, Media Fills, Mycoplasma testing. Amongst marketing, I perform consulting and scientific support: internal and external trainings, seminars on Microbiological Environmental Monitoring. Expert of committees: AFNOR X44B "cleanrooms technology ", ISO TC 209 international cleanrooms standard, CEN/TC243 WG “Cleanrooms and associated controlled environments Biocontamination” Before, I managed products for medical diagnostic (in serology, bacteriology…), and microbiology alternative methods.

    Sebastian Scheler

    Chief Methodologist and Co-Founder, Innerspace GmbH
    Sebastian Scheler

    Sebastian Scheler (born 1987) is a qualified psychologist and expert trainer. As Co-founder and Lead Psychologist (since 2017) at Innerspace - The DeepTraining Company, he is not only responsible for company management moreover for the global business development and implementation of DeepTraining products in the pharmaceutical industry. As an expert in training transfer and human error analysis, he is also a speaker at various specialist events.

    Stephen Ward

    General Secretary, Contamination Control Network
    Stephen Ward

    Stephen is a principle in the Validair Group of companies, offering consultancy, cleanroom testing, monitoring systems and calibration and has been involved in the testing of cleanrooms for over 30 years. He was the UK’s subject matter expert for ISO TC209/WG3 on the revision of the ISO 14644-3 standard and is also the expert for ISO TC209/WG4 for the revision to the ISO14644-4 standard. Stephen’s other roles include Deputy Chairman of LBI30, the Cleanroom Technology Committee at BSI, an examiner for the Cleanroom Testing and Certification Board (CTCBi) and Secretary of the UK Contamination Control Network (CCN).

    Tim Sandle

    Bio Banking Operations, Bio Products Laboratory
    Tim Sandle

    Walid El Azab

    Senior Manager Technical Services , Steris Corporation
    Walid El Azab

    Walid El Azab is an Industrial pharmacist, a Qualified Person and Lean Six Sigma green belt. He is a Senior Manager Technical Services for STERIS Life Sciences. He currently provides technical support related to contamination control progral and process validation. He also leads workshops to improve inspection readiness and contamination control levels
    He is an active member of the PDA, ISPE, ECA, and A3P with numerous published articles and book chapters on contamination control. He is a member of the A3P GIC working group on sterilization, draft Annex 1, rouging, contamination control strategy and the ECA task force regarding the revision of the EU GMP Annex 1. He also leads workshop at the UPIP-VAPI EU GMP Annex 1 and at the ECA contamination control strategy task force. He is a planning committee member of the EU Annual PDA Conference (1st and 2nd) biomanufacturing. He is also an Editorial Committee Member of the PDA Letter. Finally, Walid is a board member of the Belgium Qualified Person (UPIP-VAPI) association and a co-founder of the Belgium QP Academy.
     

    Sponsors

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Cleanroom garments – need, function and use
    Workshop

    Cleanroom garments – need, function and use

    Holiday Inn Kensington Forum
    5th October 2021
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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

    Speaker Interview with Dawn Watson, Merck

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    Pharmaceutical Cleanroom Speakers 2021

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    Pharmaceutical Cleanroom Long Programme 2021

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    Pharmaceutical Cleanroom Short Programme 2021

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    Pharmaceutical Cleanroom Brochure 2021

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    Pharmaceutical Cleanroom – Past Attendees

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    Pharmaceutical Cleanroom Pre-Conference Workshops

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    Past Presentation - Dr Alana Poloni, Fresenius Kabi

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    Past Presentation – MrvAlexander Stoll, Fresenius Kabi

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    Past Presentation – Mr James Drinkwater, PHSS

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    Past Presentation – Professor Matts Ramstorp, BioTekPro AB

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    Past Presentation – Ms Siobhan Murphy, Contec

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    Past Presentation – Mr Conor Murray, Irish Cleanroom Society

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    Past Presentation - Dr Isabelle Tovena Pecault, Aplha RLH

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    Past Presentation – Mr Steve Marnach, Dupont

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    Past Presentation – Mr Pier Angelo Galligani , Techniconsult

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    Past Presentation – Mr Koos Agricola, Brookhuis

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    Past Presentation – Mr Keith Beattie, EEC

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    Past Presentation – Mr Christian Pruckner , BioPhorum

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    Sponsors


    Ecolab

    Sponsors
    https://en-uk.ecolab.com/

    Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry.

    Our comprehensive solutions and technical expertise are focused on cleaning, sanitisation and contamination control, all while ensuring safety, compliance and operational efficiency.



    Innerspace

    Sponsors
    https://www.innerspace.eu/

    Innerspace develops revolutionary training systems, in which aseptic production employees learn to master the key moments of their work. Innerspace uses high end Virtual Reality technology to implement research breakthroughs in Human Error Analysis and Transfer research into a powerful DeepTraining system. The DeepTrainings modules offer safe environments for repeatable, focused virtual experiences that create real, goal driven work experience. In addition, the Training Management System supports documentation and integration of training data. All that allows Innerspace to support its customers with a cutting-edge digital solution to train employees in one of the most critical fields of human interaction in aseptic manufacturing.

    Exhibitors


    Elis Cleanroom

    Exhibitors
    http://www.elis.com

    Elis Cleanroom are your contamination control partner for all your cleanroom laundry requirements. Our solutions for your business include garment rental, cleaning systems, mats, sterile goggles, footwear and stock tracking with our online Connected Cleanroom™ data system. With 28 cleanrooms in 17 countries we offer contingency, for peace of mind.


    Microgenetics

    Exhibitors
    https://www.microgenetics.co.uk/

    Environmental monitoring can be time-consuming and is open to risks, including data duplication and transcription errors. That’s why at Microgenetics, we’ve developed SmartControl as a new way for you to capture, manage and track your data, making your lab paperless, efficient and smart.

    SmartControl makes it easy for users to meet regulation, enhance data integrity and take better environmental monitoring decisions. It’s compliant with FDA 21 CFR Part 11 and GMP Annex 11, yet simple to use. Booking in a plate takes just 6 seconds, with in-depth analysis and reporting at your fingertips.

    Plus, it’s easy to set up. Being a cloud-based software, testing and validation is completed by Microgenetics and there’s no physical server installation. This means you could have the software running in your facility in just 6 weeks. Any subsequent updates – whether this means new and improved features, or updates in line with new regulation - are also hassle-free, too.

    Are you ready to bring your lab into the future?


    Media Partners


    Pharma Journalist

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

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    pharmanews hq

    Official Media Partner
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Farmavita

    Official Media Partner
    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!


    Rapid Microbiology.com

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

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

    Media Partners


    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.


    Genetic Engineering News

    Supporters
    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


    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.


    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.


    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.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    American Pharmaceutical Review

    Supporters
    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


    MedTube

    Supporters
    https://medtube.net/



    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….


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    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.


    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


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

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


    MYTECHMAG

    Supporters
    https://www.mytechmag.com/

    Transforming news into insights, not only do we serve as a source of information but as the breeding ground for innovative ideas and exchange of breath-taking strategies that can make a difference in your technological understanding. We bring forth an enhanced, clever and a comprehensive platform which can assist the information seekers a filtered view of what they are searching. Our technology magazine is spearheading a revolution to provide knowledgeable articles written in simple yet lucid language that can give an insight into the latest in the world of technology.

    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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