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The SAE Media Group is proud to announce the 2nd annual Aseptic Processing Conference
20th September, 2022 | London, UK
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In light of the passing of Her Majesty Queen Elizabeth II and the forthcoming funeral and bank holiday taking place on Monday 19th September, the Aseptic Processing conference will be shortened to a one-day event on Tuesday 20th September. We will be including all planned presentations on the Tuesday to ensure you still receive maximum value from the conference and we appreciate your understanding. We look forward to welcoming you to the conference on Tuesday 20th September.

The Aseptic processing industry has seen consistent growth in recent years -- with advances in innovative therapeutics, the introduction of novel techniques and personnel protocols, the integration of robotics and automation in filling lines, and rise of rapid microbiological methods being just a few of the factors driving this growth.

Aseptic Processing comes at the point in the manufacturing of pharmaceuticals where the product itself is at its highest value, and with such high investment comes many complex challenges to discuss, explore, and overcome -- ultimately via careful planning, thoroughly trained personnel, and specialised facilities and equipment.

The Aseptic Processing equipment market was approaching a valuation of 10 billion USD in 2015, and is projected to exceed 12 billion USD in value by next year, then to far surpass a total market value of 50 billion USD before the end of the decade.


The industry is also seeing critical changes in the regulation and guidance – fundamental documents and principles of implementation are in a pressing need to be dissected and discussed, and essential insights into applying Quality Risk Management practices to the manufacture of biopharmaceutical products are more relevant than ever.

Join us this year to explore the novel methods and technologies pushing innovation in the field.
 

 

  • Discuss the revisions and the impact of Annex 1 on aseptic manufacturing
  • Explore the applications of rapid micro methods in the manufacture of sterile products 
  • Discover a Risk Based Approach to Cleaning and Disinfection
  • Delve into case studies of competence in global aseptic manufacturing
  • Uncover the journey of Isolation Technology in a large Biotech pharmaceutical plant

 

  • Validation Managers
  • Quality Control Managers
  • Quality Assurance Experts
  • Leaders in Sterility Assurance
  • Cleanroom Managers
  • Regulatory Affairs Managers
  • Production Managers
  • Quality Systems Managers
  • Senior Sterility Assurance Manager
  • Sterility Assurance Specialist
  • Sterile Manufacturing Manager
  • Senior Microbiologist
  • Sterile Manufacturing Specialist
  • Lead Scientist
  • Laboratory Manager
  • QA Specialist
  • Drug Substance External Manufacturer
  • QC Scientists
  • Heads of Quality Control
  • Business Development Manager
  • Pharmaceutical Microbiology Consultant
  • Higher Pharmacopoeial Scientist
  • Analytical Standards Specialist

     

 

Abbott Laboratories; Advanced Sterilization Products (J&J); Ajinomoto Althea, Inc.; Allergan; Althea; Amneal Pharmaceuticals; Associates of Cape Cod; Association of Cape Cod, Inc; AstraZeneca; Atara Biotherapeutics; Battelle Memorial Institute; Bayer Healthcare; Bimeda; Biofiredx; Biomerieux; bioMerieux Industry; Bioscience International; BioVectra Inc; BioVigilant Systems; Charles River; Charles River Laboratories; Fujifilm Wako Chemicals USA Corp; Genentech; Genentech Inc; Genentech, Inc; Gilead Sciences; Grifols Biologicals; Janssen; Lonza Walkersville, Inc.; Mettler Toledo; Microbiologics; Microrite Inc.; Microrite, Inc.; Millipore Sigma; Morphotek, Inc.; Mycoplasma Biosafety Services GmbH; Northstar Medical Radioisotopes; Novatek International; QuVa Phama; Rapid Micro Biosystems; Regeneron Pharmaceuticals; Revance Therapeutics; Roche; San Diego State University, Women in Science Society; Steris Corporation; Takeda Pharmaceutical Company Limited; Teva Pharmaceuticals; UCSD; Ultragenyx Pharmaceutical; University of California San Diego; University of New England; University of Veterinary Medicine Vienna; Vital Therapies; Xellia Pharmaceuticals;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

James L. Drinkwater

James L. Drinkwater, Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
View Bio

9:05 implementing regulation changes including EU GMP Annex 1, ICHQ9 (QrM) and ICHQ12 (product life cycle strategies)

James L. Drinkwater

James L. Drinkwater, Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
View Bio

Preparation of a Contamination Control Strategy (CCS) as a new Annex 1 requirement – overview on available guidance from PHSS-A3P, PDA, ECA and regulatory expectations on implementation.
Enhancing Quality Risk Management (QRM) via revision of ICHQ9 and re-enforcement of principles over the entirety of Annex 1 requirements. What is the impact of ICHQ9 revision?
Requirements of a Gap analysis as regulations change and how to go about such a requirement – key points to be discussed in Regulation Change Discussion session.
• Annex 1 does not use the term holistic but instead there is a focus on collective effectiveness of control measures that requires combined environmental monitoring and process monitoring data together with trend analysis and knowledge management over the product life cycle so a more proactive approach can be taken. This is leading to more continuous process verifi cation (aligning with FDA initiatives) and digitalisation of data for review/ reporting.

9:35 Data Integrity – Challenges in microbiology testing

Di Morris

Di Morris, Clinical Auditor, AstraZeneca
View Bio

• First principles of data integrity, assurance of data consistency and accuracy throughout its life cycle
• Definitions, five essential concepts explained – Assuring data is Attributable, Legible, Contemporaneous, Original, and Accurate
• Focus: Handling qualitative and quantitative Microbiological data,
• How to avoid Issues in data integrity
 

10:05 Combination Formulation-Fill-Finish of ATMPs: Lentiviral Vector - Oxbox Case Study

James L. Drinkwater

James L. Drinkwater, Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
View Bio

  • Overview of Oxford Biomedica and Oxbox Project
  • Contamination control risk assessment for Oxbox Facility and Fill Finish Process
  • Development of a Contamination Control Strategy
  • Learning Points and Summary
  • 10:35 Improvement of contamination control strategy by using Growth Direct System (GDS)

    Johannes Oberdoerfer

    Johannes Oberdoerfer, Field Application Scientist, Rapid Micro Biosystems
    View Bio

    • Challenges of modern Microbiologists
    • Solution to microbiology challenges – The Growth Direct System
    • Areas of application – Challenges and Solutions
     

    11:05 Morning Coffee

    11:35 Choosing and validating a sterility test isolator for the microbiological laboratory

    Henrietta Vinneras

    Henrietta Vinneras, Head of QC, PU Uppsala and Brunna, Fresenius Kabi
    View Bio

    • Choosing an isolator to enable testing of very large product samples (LVP’s, large volume parenterals) as well as small product samples (SVP’s)
    • Designing a process for sterility testing which is both ergonomic and provides sufficient sterility assurance for the test environment and samples
    • Qualifying and validating the equipment and process
    • Lessons Learned from the project
     

    12:05 A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell & Gene Therapy Cleanroom

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation
    View Bio

    • A risk-based approach to pass thru decon. of critical items into cleanrooms and RABS
    • How to control hard-to-kill fungal spores such as Aspergillus and Chaetomium as well as bacterial spores and viruses
    • Recent case studies from the past few months in cell and gene therapy and compounding pharmacies will be discussed in relation to pass thru decon.
    • Reviewing published data to convey effective methods in control bioburden into the APA
    • A holistic approach to controlling bioburden from entering cleanrooms and controlled rooms
     

    12:35 Innovative VPHP biodecontamination validation of a new syringe filling line

    Serena Ambrosini

    Serena Ambrosini, Sterile Manufacturing Technical Manager, AstraZeneca
    View Bio

    • Challenges in designing a new process for a legacy product
    • VHP decontamination zoning to increase line flexibility
    • Cycle validation strategy based on use of Enzymatic Indicators
     

    13:05 To measure is to know – protect your biologics during filling by ultrasensitive online H2O2 monitoring

    Ruthger Van Zwieten

    Ruthger Van Zwieten, Sales Director EMEA, Picarro, Inc
    View Bio

  • VHP cycle development
  • Outgassing characterization
  • Online monitoring during concentration-based aeration
  • Including customer showcases (NHS and AbbVie)
  • 13:35 Networking Lunch

    14:35 Beyond Robotics: State of the art automation solutions for Pharma

    Fabian  Stutz

    Fabian Stutz, CEO, Pharmabotix AG
    View Bio

    • Smart end-to-end solutions in a modern production environment
    • Logistics first?
    • Key factors for the success of an automation project
    • Operability of a machine in the 21st century / HMI Technology
     

    15:05 GMP Requirements for the use of Robotics in aseptic manufacturing

    Richard Denk

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

    • Requirements according to the newest draft of the EU GMP Annex 1
    • Contamination Control Strategy using Robotics
    • Cleaning, and Cross Contamination prevention
     

    15:35 Fireside Chat: Discussion on regulation changes (Annex 1, icHQ9, icHQ12) and impact considering a gap analysis to meet new and enhanced requirements

  • Once EU GMP Annex 1 is published many will be faced with a Gap analysis considering current state of GMP compliance (original Annex 1 – 15 pages) and gap between new and enhanced requirements in the revised Annex 1 (50 pages). This discussion will focus on what is new and enhanced requirements.
  • The Gap analysis will be required before a CCS (Contamination Control Strategy) can be prepared. Application of contamination control, monitoring and metrics will need to follow QRM principles through the product life cycle.
  • The discussion will cover the expectations of following an holistic and proactive approach in contamination control through sterile product manufacturing via Aseptic processing with deviation response management together with life cycle strategies.
  • James L. Drinkwater

    James L. Drinkwater, Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
    View Bio

    Di Morris

    Di Morris, Clinical Auditor, AstraZeneca
    View Bio

    16:05 Afternoon Tea

    16:35 Current regulatory challenges of Biologics Drug products manufacturing

    Gowri Sukumar

    Gowri Sukumar, Senior Director , Iterion Therapeutics Inc
    View Bio

  • Overview of Current guidelines and regulations on Quality Microbial content of BLA
  • In-depth discussion on Common deficiencies in DP manufacturing across three areas
  • 1. Sterilizing filtration
  • 2. Post reconstitution and post dilution storage
  • 3. Container closure integrity
  • Summary and conclusion
  • 17:05 MCP deposition rates (ISO 14644-17) and surface monitoring (ISO 14644-9)

    Koos Agricola

    Koos Agricola, Contamination Control Specialist, Brookhuis Applied Data Intelligence
    View Bio

    • Understanding particle contamination mechanisms to reduce the risk of product contamination
    • Contamination control solutions towards particle deposition rates on vulnerable surfaces in a cleanroom
    • Establish control by cleanroom ventilation and operational procedures
    • Demonstrate control by monitoring air cleanliness and particle deposition rate
     

    17:35 Global Technical Education Program for Sterile Manufacturing (PNTK)

    Naomi Deal Rich

    Naomi Deal Rich, Associate Director-Learning & Development Strategy | Global Manufacturing & Quality, Eli Lilly and Company

    • Addressing the need of Technical Education for Professionals
    • Developing CBTs with movies/photos taken from real equipment, real processes
    • Use both for campus recruits but also for people job rotating into sterile manufacturing
    • High level overview to provide awareness and to explain the why’s
     

    18:05 Chair’s Closing Remarks and Close of Day

    James L. Drinkwater

    James L. Drinkwater, Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
    View Bio

    +

    FEATURED SPEAKERS

    Di Morris

    Di Morris

    Clinical Auditor, AstraZeneca
    Fabian  Stutz

    Fabian Stutz

    CEO, Pharmabotix AG
    Gowri Sukumar

    Gowri Sukumar

    Senior Director , Iterion Therapeutics Inc
    James L. Drinkwater

    James L. Drinkwater

    Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
    Jim Polarine

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Johannes Oberdoerfer

    Johannes Oberdoerfer

    Field Application Scientist, Rapid Micro Biosystems
    Koos Agricola

    Koos Agricola

    Contamination Control Specialist, Brookhuis Applied Data Intelligence
    Naomi Deal Rich

    Naomi Deal Rich

    Associate Director-Learning & Development Strategy | Global Manufacturing & Quality, Eli Lilly and Company
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Ruthger Van Zwieten

    Ruthger Van Zwieten

    Sales Director EMEA, Picarro, Inc
    Serena Ambrosini

    Serena Ambrosini

    Sterile Manufacturing Technical Manager, AstraZeneca

    Di Morris

    Clinical Auditor, AstraZeneca
    Di Morris

    Di Morris - MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.
     

    Fabian Stutz

    CEO, Pharmabotix AG
    Fabian  Stutz

    I am the CEO & Head of Sales with Pharmabotix AG, a company that provides clients with innovative robotics and automation solutions for the pharmaceutical industry. From building an effective team to maintaining a large customer network, I am adept at driving business development while delivering exceptional service to customers with a direct communications approach. I am passionate about trying new ideas and providing honest feedback on feasibility to ensure customer satisfaction.

    Gowri Sukumar

    Senior Director , Iterion Therapeutics Inc
    Gowri Sukumar

    Gowri Sukumar is the Senior Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the technical disciplines of CMC development as well as regulatory Affairs. She has broad responsibilities that include process development, Drug Substance and Drug Product manufacturing from the CMC side. From the Regulatory affairs perspective, she provides regulatory leadership and expertise for regulatory strategy, liaises with the regulatory agencies including FDA, Health Canada and other Health authorities. For her leadership approach, she brings a strong focus beyond the necessary technical disciplines and regulations, looking at the interplay of culture and teamwork for successfully advancing programs in an effective and efficient manner. Gowri holds a master’s Degree in Biosciences as well as the prestigious Regulatory Affairs Certification (RAC) awarded by the Regulatory Affairs Professional Society. She is the author or co-author of several peer-reviewed research publications as well as book chapters. Gowri has breath of experience spanning R&D, CMC and Regulatory affairs. She also serves as a reviewer for several international Bioscience Journals for providing Scientific and technical expertise.

    Henrietta Vinneras

    Head of QC, PU Uppsala and Brunna, Fresenius Kabi
    Henrietta Vinneras

    Mrs Vinnerås has been in the industry since year 2000 and has worked for pharmaceutical and medical device companies such as Pfizer, Abbott, GE Healthcare, Thermo Fisher Scientific and currently at Fresenius Kabi.

    Mrs Vinnerås was previously part of a global competence center supporting mainly the companys’ pharmaceutical manufacturing, medical devices and compounding centers world-wide with e.g. establishing global corporate procedures, on-site assessments etc; specifically within the areas of microbiology and aseptic technique. Currently she is the head of QC for the production units in Uppsala and Brunna, Sweden.

    She is also a member of the PDA Journal of Pharmaceutical Sciences and Technology editorial board.
     

    James L. Drinkwater

    Head of GMP Compliance, PHSS Co-Lead of CCS Guidance Initiative, F Ziel GmbH and PHSS
    James L. Drinkwater

    James is based in the UK with a global support role at F Ziel who are the largest Isolator and RABS manufacturer in Germany. James is the Ex-Chairman (10 years) and current Head of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing special interest group and Co-lead of the EU GMP Annex 1 implementation and Contamination Control Strategy (CCS) Focus groups. Working experience includes 10 years in radio pharmaceutical manufacturing (Amersham-GE Healthcare) and over 30 years working in sterile medicinal product manufacturing support where increasingly aseptic processing applies to ATMPs, particularly Gene and Cell therapies. James is a qualified pharmaceutical process engineer with addition education in pharmaceutical microbiology and a subject matter expert in Barrier Technology (Isolators and RABS) and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of ISPE and Pharmaceutical Quality Group UK (PQG).

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Jim Polarine

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force and the PDA’s Microbial Excursions Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

    Johannes Oberdoerfer

    Field Application Scientist, Rapid Micro Biosystems
    Johannes Oberdoerfer

    As Field Application Scientist at Rapid Micro Biosystems, Johannes is responsible for the successful implementation of the Growth Direct System within companies across Europe. He is supporting customers during selection and successful implementation of state-of-the-art technologies in the microbiology routine labs. With this, his main task is to drive the transformation of the labs in terms of automation, innovation and digitalization.
    Johannes has worked across multiple disciplines along his career including Research and Development, Quality Control and Microbiology at Boehringer Ingelheim Pharma GmbH & Co.KG.
    Johannes holds a Bachelor’s Degree in Process Engineering Biopharmaceuticals by the University of Applied Sciences, Bingen, Germany.
     

    Koos Agricola

    Contamination Control Specialist, Brookhuis Applied Data Intelligence
    Koos Agricola

    Koos is an applied physicist with 35 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. At R&D of Canon Production Printing (formerly Océ Technologies) he has developed various processes and facilities for printing devices.
    He is secretary of the ICCCS (International Confederation of Contamination Control Societies). He is secretary, 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) and secretary and treasurer of the VCCN (Netherlands Contamination Control Society).
    He wrote various papers on the determination of requirements of cleanrooms, operational procedures and monitoring surface contamination.
     

    Naomi Deal Rich

    Associate Director-Learning & Development Strategy | Global Manufacturing & Quality, Eli Lilly and Company
    Naomi Deal Rich

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Richard Denk

    Richard Denk is working at the company SKAN AG, headquartered in Allschwil Switzerland in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group, ISPE Sterile Product Processing Group, Chair of the ISPE Containment DACH, the ISPE SIG Robotic and Co-Chair ISPE SIG Bio on Innovations and Technology. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group.

    Ruthger Van Zwieten

    Sales Director EMEA, Picarro, Inc
    Ruthger Van Zwieten

    Ruthger van Zwieten received his PhD in Gene and Cell Therapy from the University of Lausanne, Switzerland and developed the research plan for a pharma start-up before transitioning into Business Development roles in Natural Sciences companies. He has been with Picarro since November 2019 and has an intimate connection with the Picarro H2O2 CRDS Pharma Analyzer which has a major role in the filling of Biopharmaceuticals.

    Serena Ambrosini

    Sterile Manufacturing Technical Manager, AstraZeneca
    Serena Ambrosini

    Serena Ambrosini has a MSc in Pharmaceutical Chemistry (2007) and a PhD in Analytical Chemistry (2010). Serena has worked in Fedegari and GSK in Italy and she currently holds the position of Sterile Manufacturing Technical Manager in AstraZeneca (UK). During her career she has led the implementation of sterility assurance improvement projects and contributed to increase the robustness of the site sterilization processes. She is presently leading the implementation of the VHP decontamination of two new aseptic filling lines from definition of the validation strategy to handover to operations.

    Sponsors

    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

    Preliminary Attendees List

    Download

    Speaker Biographies

    Download

    Conference Chair Letter

    Download

    Workshop Agenda

    Download

    Aseptic Processing Brochure 2022

    Download

    Past Attendees

    Download

    Past Presentation - Richard Denk, SKAN AG

    Download

    Past Presentation - Professor Matts Ramstorp, BioTekPro AB

    Download

    Past Presentation - Andrew Hopkins, ABBVIE

    Download

    Past Presentation - Jim Polarine, STERIS

    Download

    Past Presentation - Dr. Alexander Stoll, Fresenius Kabi

    Download

    Past Presentation - Aled Jones, Teva Pharmaceuticals

    Download

    Sponsors


    Picarro

    Sponsors
    https://mktg.picarro.com/acton/fs/blocks/showLandingPage/a/39674/p/p-004f/t/page/fm/0

    Picarro provides solutions that deliver real-time measurements of hydrogen peroxide at parts-per-billion (ppb) sensitivity with negligible drift for pharmaceutical, CMO, and isolator applications. By combining precision, ease-of-use, and low maintenance requirements, Picarro solutions ensure ultra-low residual hydrogen peroxide levels for good manufacturing process (GMP) pharmaceutical production, and shorten aeration cycles. For more information, visit www.picarro.com


    Rapid Micro Biosystems

    Sponsors
    http://www.rapidmicrobio.com

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

    Exhibitors


    Dec Group

    Exhibitors
    https://www.dec-group.net/fillinglines

    Dec is a leading global provider of contained powder handling systems and is recognized as a world-leading expert in process containment technologies. It has been supplying the pharmaceutical, chemical, food and cosmetic industries for more than 30 years. In excess of 600 companies worldwide have successfully integrated more than 10,000 Dec systems and concepts into their production sites, always enhancing safety, containment and productivity. Dec offers innovative approaches across the range of powder handling and process containment applications, including transfer, micronizing/milling, bulk handling, sampling, blending, dosing, aseptic fill-finish solutions, process isolators and containment solutions as well as advanced cleaning (CIP/SIP) features.


    Microgenetics

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

    Innovation is at our core. It is, after all, the reason we formed back in 2014 when our sister company Bath ASU needed a new, smarter method for microbiological environmental monitoring. As a result, our passionate team has developed products that innovate microbiology and molecular diagnostic technologies for the pharmaceutical industry, kickstarting our mission to help win the war against pathogens. SmartControl EM is our environmental monitoring software; built in line with EU GMP Annex 11 and FDA CFR Part 11, it helps users meet regulation, enhance data integrity and take better environmental monitoring decisions. Also in the SmartControl family, our Colony Counter uses Machine Learning to automate the slow and error-prone colony counting process, even for complex plates such as environmental monitoring samples. Finally, SwiftDetect is our rapid sterility test, capable of testing down to a single cell of contamination, harnessing results in under 6 hours.



    Raumedic

    Exhibitors
    http://www.raumedic.com

    Together with its customers, the medical technology company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care. Raumedic has a global presence and a headcount of approximately 1,000. In its core markets of Europe and North America, the company manufactures using its own clean room production facilities.


    STERIS

    Exhibitors
    http://www.sterislifesciences.com

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

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

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


    Media Partners


    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


    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.


    MedTube

    Supporters
    https://medtube.net/



    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

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


    Pharma Journalist

    Supporters
    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.


    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


    Farmavita

    Supporters
    https://farmavitar.com

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


    Contract Biotechnology

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

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


    American Pharmaceutical Review

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    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


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    http://www.worldpharmanews.com/



    Pharmalicensing

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    http://www.pharmalicensing.com

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


    Biocompare

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    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.

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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, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

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

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

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




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