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SMi proudly presents the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference being held in London on 7 - 8 October 2020.

It is a critical time for cleanrooms as new regulations in GMP enter their final drafts after several months in review. This conference will explore the forecasted impacts of the new regulations across the pharmaceutical cleanroom industry, from designer to operator.

These significant updates will be influential in the regulatory procedure across the cleanroom industry and come at a time when the global cleanroom technologies market is set to surpass GBP 3 billion in value.


This rapidly growing industry sustains an identical rate of evolution; technological leaps in airflow visualisation and environmental monitoring provide deeper insight into cleanroom management and contribute to the increasing standards in sterility. Additionally, the development of entirely new medicines is forcing new regulatory measures into play.


The agenda will look deeply into the influence of the developments in Annex 1, ISO 14644 and GMP compliance, as well as insights into the novel technologies surfacing in this industry, from robotics and automation to isolator technology implementation.


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:

  • UNDERSTAND the current regulatory landscape from both designer and regulator perspectives
  • EXPLORE the innovations in technology that are shaping the next generation of cleanroom facilities
  • DETERMINE the best approaches to cleanroom design and operation from global case studies
  • GAIN insight into the latest ideas in cleanroom protocol and operation from leading industry experts
     

 

Heads, Managers, Directors, Experts:

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

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 (PO6500579899); 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, Professor in Cleanroom Technology, BioTekPro AB
View Bio

9:10 Establishing a contamination control strategy for aseptic processing

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 Session reserved for Innerspace

10:30 Morning Coffee

11:00 Challenges of creating cleanrooms fit for purpose

Patrizia Muscas

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

• 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

11:40 Modern lab and filling suite design

12:20 Networking Lunch

13:20 Cleanroom Operators – Still a major potential risk

Matts Ramstorp

Matts Ramstorp, Professor in Cleanroom Technology, 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
 

14:00 Contamination Control Strategy; a strategic management or a control strategy approach

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
 

14:40 Afternoon Tea

15:10 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
 

15:50 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
 

16:30 Chair’s Closing Remarks and Close of Day One

Matts Ramstorp

Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB
View Bio

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Matts Ramstorp

Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB
View Bio

9:10 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
 

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 Morning Coffee

11:00 Reducing environmental monitoring excursions in a manufacturing environment

Dawn Tavalasky

Dawn Tavalasky, Senior Director Gloabl 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
 

11:40 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
 

12:20 Networking lunch

13:20 The necessity of improving access techniques with Annex 1

Francesca  Burberi

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

• Requirements for gowning and access design improvements for classified areas
• Present vs Future design: definition of the gap analysis and advantages of implementation
• Creating a sustainable design: a real example and its implication to comply with Annex 1
• Example of technical solutions to monitoring access through technology: the smart watch real case
 

14:00 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
 

14:40 Afternoon Tea

15:10 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 verifi cation
• Guidance for life science applications
 

15:50 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
 

16:30 Chair’s Closing Remarks and Close of Day Two

Matts Ramstorp

Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB
View Bio

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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 Tavalasky

Dawn Tavalasky

Senior Director Gloabl Sterility Assurance, Sanofi Pasteur
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
Joseph McCall

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Matts Ramstorp

Matts Ramstorp

Professor in Cleanroom Technology, BioTekPro AB
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
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.
 

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 Tavalasky

Senior Director Gloabl Sterility Assurance, Sanofi Pasteur
Dawn Tavalasky

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.

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.
 

Joseph McCall

Associate Director, QA Technical Service , ADMA Biologics
Joseph McCall

Joe McCall is the Associate Director of QA Technical Services at ADMA Biologics. He is actively involved in industry as a vetted member of the US FDA’s Network of Experts Program and has conducted training events at FDA CBER Division of Product Quality and Manufacturing on Environmental Monitoring (EM) Programs and Qualification of Disinfectant Cleaning Processes. Joe has led courses at the PDA TRI in Bethesda MD and the University of Tennessee. He is a voting member of US TAG ISO / TC209 (ISO 14644) and is one of only 32 microbiologists certified by ASM as a Specialist in Pharmaceutical and Medical Device Microbiology.

Matts Ramstorp

Professor in Cleanroom Technology, 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.

Patrizia Muscas

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

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.

Stephen Ward

General Secretary, Contamination Control Network
Stephen Ward

Stephen is a principle in the Validair Group of companies, offering cleanroom testing, monitoring systems and calibration and has been involved in the testing of cleanrooms for over 30 years. He is the UK’s subject matter expert from ISO TC209/WG3 on the revision of the ISO 14644-3 standard and 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 and a Qualified Person (QP). He is a Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation. He currently provides technical support related to cleaning, disinfectants, sterility assurance and process validation. He also leads workshops to improve inspection readiness and contamination control levels.
His areas of expertise include both upstream and downstream pharmaceutical operation and validation in non-sterile and sterile process. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, lead auditor, and QP. Walid’s responsibilities and experience have also included project management, handling deviations and complaints, releasing raw materials, drug products and investigational medicinal product (IMP), conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, SFDA, ANVISA…) audits and develop strategy approach for process, cleaning, and system gap analysis
Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium and is a certified Lean Six Sigma green belt. Walid is a lecturer at the University of Liège (Medicine faculty in Belgium).
He is an active member of the PDA, ISPE, ECA, and A3P with numerous published articles and book chapters on contamination control. He is also active with the A3P GIC working group on sterilization, and he leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and he is also part of the ECA task force regarding the revision of the EU GMP Annex 1. He is a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th) and European Biomanufacturing. He is also an Editorial and the sub art committee member of the PDA Letter. Finally, Walid is a board member of the ISPE Belgium affiliate and the Secretary of the Belgium Qualified Person (UPIP-VAPI) association.
 

Sponsors and Exhibitors

Official Media Partner

Supporters

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

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

Conference Chairman Interview - Matts Ramstorp, BioTekPro AB

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Speaker Interview - Benoît Ramond , Sanofi

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Pharmaceutical Cleanroom Pre-Conference Workshops

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Pharmaceutical Cleanroom conference speakers 2020

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Pharmaceutical Cleanroom – Past Attendees

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Conference 2-day Agenda

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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 and Exhibitors


Elis Cleanroom

Sponsors and 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.


Innerspace

Sponsors and Exhibitors
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.

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.


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.


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.

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.


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


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


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.


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.


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


MedTube

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https://medtube.net/



IBI - International Biopharmaceutical Industry

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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.


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.


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.


MYTECHMAG

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


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Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

Copthorne Tara Hotel

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

 

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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

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Opening Hours: 9.00 - 17.30 (local time)
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Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
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