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The SMi Group is proud to announce the inaugural
Aseptic Processing Conference
20th - 21st September, 2021 | Virtual Conference | All Timings are BST
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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 with AstraZeneca
  • Explore the applications of rapid micro methods in the manufacture of sterile products with AbbVie
  • Discover a Risk Based Approach to Cleaning and Disinfection with STERIS
  • Delve into case studies of competence in global aseptic manufacturing with Fresenius Kabi
  • Uncover the journey of Isolation Technology in a large Biotech pharmaceutical plant with Eli Lilly

 

  • 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

British Summer Time (BST)

8:00 Registration

9:00 Chair's Opening Remarks

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

9:10 Applying rapid micro methods in the manufacture of sterile products

Andrew  Hopkins

Andrew Hopkins, Director Audit Readiness, Abbvie
View Bio

• Combating short-lived biopharmaceuticals with rapid and compliant tests (pros and cons)
• Assessing the respective efficacies of in-house rapid testing equipment
• Evaluating rapid detection of bacterial contamination
• Candidate technologies and validation considerations and discussing some of the issues and challenges
• Regulatory engagement
• What to consider when choosing a rapid microbial identification system
 

9:50 Handling potent products inside a single use Aseptic Environment

Declan O'Shea

Declan O'Shea, Technical Sales Manager, ILC Dover
View Bio

• Observations towards increase in potent products
• Considerations around potent materials in a sterile environment
• Risk based approach to a safe working process
• Prototypes: How creating and developing many working prototypes with customers benefits both parties
• Advantages of working with flexible film isolator systems
 

10:30 Morning Break and Virtual Exhibit Hall Open

11:00 Contamination control strategies (CCS) applied to three different product types for Annex 1 compliance

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

• CCS for Aseptic processing: Formulation and Filling an ATMP viral vector
• CCS for Aseptic process filling of Cytotoxic products including lyophilization process
• CCS for Aseptic filling of bulk vaccines into vials
 

11:40 How to prepare and be ready for the revised Annex 1 – a pharmaceutical company perspective

Alexander Stoll

Alexander Stoll, VP Competence Center Microbiology & Aseptic Technique, Fresenius Kabi AB
View Bio

• Commenting strategy and active involvement in public consultations
• How to prepare global manufacturing sites and management for the changes
• How to roll-out a harmonized way of documenting the sites Contamination Control Strategies
• How to prepare for changes based on draft versions that may change
 

12:20 Networking Break and Virtual Exhibit Hall Open

13:20 Use of quality risk management for effective deviation investigations in aseptic environment

Kevin Jenkins

Kevin Jenkins, Consultant, Quality Excellence Consulting LLC
View Bio

• Conducting the investigation using DMAIC Six Sigma approach
• Use of Failure Mode Analysis (FEMA) tools
• Understanding common cause vs special cause deviations and how to respond for results
• Use of Quality Risk Management
             o Escalation as required (FAR/compliance reporting requirements
             o Review of safety/medical implications to patients
             o Holistic approach
• Choosing effective CAPA
• Control phase and demonstrated CAPA effectiveness
• Case studies, investigations and corrective actions for:
             o Media fill failure
             o Sterility failure
             o Microbiological contamination from personnel/environment
 

14:00 Risk Based Approach to Cleaning and Disinfection in sterile manufacturing facilities

James Polarine Jr

James Polarine Jr, Senior Global Technical Service Manager, Steris Corporation
View Bio

• Covers risk assessment and CAPA investigations on fungal spore and bacterial spore contamination in cleanrooms
• Discuss the most current regulations regarding conducting CAPA investigations
• Examples of current excursion investigations highlighting preventive measures will be presented as case studies
• Detailed coverage of the latest methods in conducting risk-based investigations and risk maps
• Learn methods to proactively prevent contamination events from occurring through discussing the most common sources of bioburden contamination
• A global approach to future pandemics and keeping a safe and healthy manufacturing facility

 

14:40 Afternoon Break and Virtual Exhibit Hall Open

15:10 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
 

15:50 Use of alternative methodologies in assessing VHP cycle effectiveness

Aled Jones

Aled Jones, Director Sterile – Global MST, Teva Pharmaceuticals
View Bio

• Review of current VHP methodologies
• How to dynamically assess overkill/VHP effectiveness for qualification and validation studies by rate of change, leading to: -
        o A method to assess VHP cycle performance drift
        o A simple way to process confirm production VHP cycles
 

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

James Drinkwater

James Drinkwater, Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS: Pharmaceutical & Healthcare Sciences Society
View Bio

8:30 Registration

9:00 Chair's Opening Remarks

Richard Denk

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

9:10 Strategies in developing an isolator/RABS glove management strategy for aseptic processing

Dan O'Mahony

Dan O'Mahony, Director, Sterile & Validation CoE, Global Technical Operations, MSD
View Bio

• Global regulatory updates
• Review key characteristic risks between isolators and RABS – risk mitigation strategies such as impact investigations, response to leak detection and leak integrity monitoring
• Reviewing guideline documentation for glove management and QRM for gloves
• Case study of isolator glove management control strategy
 

9:50 The journey of Isolation Technology in a large Biotech pharmaceutical plant

Mauro Giusti

Mauro Giusti, Advisor, Site External Network, Eli Lilly Italia
View Bio

• Multiple decontamination technologies (heated plate and proprietary systems)
• Multiple platforms (cartridges and syringes)
• Benefits (productivity, loss avoidance, energy saving, people training, etc.)
• Watch outs (decontamination cycle variability, periodic revalidation, glove management, etc.)
 

10:30 Morning Break and Virtual Exhibit Hall Open

11:00 Innerspace Cleanroom Simulator – possibilities and frontiers of Virtual Reality

Sebastian Scheler

Sebastian Scheler, Chief Methodologist, 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?

 

11:40 Discuss the revisions and the impact of Annex 1 on aseptic manufacturing

Di Morris

Di Morris, Senior Lead Auditor, AstraZeneca
View Bio

• Navigating through the latest revisions of Annex 1and its impact on aseptic manufacturing
• An account of the current state of the Annex 1 and a comparison with parallel guidance documents
• Discuss the key requirements such as QRM, process simulations, container closure integrity, isolators and barrier systems, and much more
• Looking into the impact of Annex 1 with respect to current control and monitoring strategies
• How the upcoming changes will affect pharmaceutical companies globally

12:20 Networking Break and Virtual Exhibit Hall Open

13:20 Case study - Transforming an existing sterile operations facility and aseptic processes in line with the latest cGMP requirements (e.g., Annex 1)

Stijn Vissers

Stijn Vissers, Director Sterile Operations, Organon
View Bio

• Scope and design
• Phased approach – project and governance structure
• Risk mitigation
• Key takeaways
 

14:00 Drivers for change in Aseptic Automation

David Phasey

David Phasey, Projects Director, 3P innovation
View Bio

  • The trend towards custom automation in response to the macro trends in the aseptic automation sector.
  •                 o New and innovative injectable devices for home administration and care giver convenience.
                    o A move from glass to plastic (COC) primary drug containers.
                    o Reduction in batch sizes taken advantage of by tub-based supply of primary drug containers.
                    o Rapid growth in the need for precision aseptic powder filling technology.
                    o A rise in the use of robotics and automation to reduce the risk of contamination and/or operator error.
                    o How the commercialisation of Cell and Gene therapies (ATMPs) is being hampered by the lack of custom automation solutions.
     

    14:40 Afternoon Break and Virtual Exhibit Hall Open

    15:10 cGMP for CAR T-Cell Therapy Products

    Scott Nichols

    Scott Nichols, Quality Compliance Lead, Kite Pharma
    View Bio

    • Regulatory Basis of Car T GMP Manufacture
    • Car T Facilities v. Traditional Biotech Facilities
    • Hot Topics in Car T Manufacture
     

    15:50 Fulfilling GMP compliance in aseptic processing and ATMP manufacturing

    Richard Denk

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

    • Regulatory updates Annex 1 Draft and PICs Annex 2B draft
    • Key Requirements for Processing in Isolator Technologies like Glove Management and Surface Decontamination
    • Novel concepts in fill-finish
    • Managing cross contamination in multi-product facilities
     

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

    Richard Denk

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

    +

    FEATURED SPEAKERS

    Aled Jones

    Aled Jones

    Director Sterile – Global MST, Teva Pharmaceuticals
    Alexander Stoll

    Alexander Stoll

    VP Competence Center Microbiology & Aseptic Technique, Fresenius Kabi AB
    Andrew  Hopkins

    Andrew Hopkins

    Director Audit Readiness, Abbvie
    Dan O'Mahony

    Dan O'Mahony

    Director, Sterile & Validation CoE, Global Technical Operations, MSD
    Declan O'Shea

    Declan O'Shea

    Technical Sales Manager, ILC Dover
    Di Morris

    Di Morris

    Senior Lead Auditor, AstraZeneca
    James Drinkwater

    James Drinkwater

    Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS: Pharmaceutical & Healthcare Sciences Society
    James Polarine Jr

    James Polarine Jr

    Senior Global Technical Service Manager, Steris Corporation
    Kevin Jenkins

    Kevin Jenkins

    Consultant, Quality Excellence Consulting LLC
    Matts Ramstorp

    Matts Ramstorp

    CEO & Founder, BioTekPro AB
    Mauro Giusti

    Mauro Giusti

    Advisor, Site External Network, Eli Lilly Italia
    Richard Denk

    Richard Denk

    Senior Consultant Aseptic Processing & Containment, SKAN AG
    Scott Nichols

    Scott Nichols

    Quality Compliance Lead, Kite Pharma
    Sebastian Scheler

    Sebastian Scheler

    Chief Methodologist, Innerspace GmbH
    Stijn Vissers

    Stijn Vissers

    Director Sterile Operations, Organon

    Aled Jones

    Director Sterile – Global MST, Teva Pharmaceuticals
    Aled Jones

    Dr Aled Jones is the Head of MST for Ipsen Biopharm Ltd and responsible for a team of technical specialists supporting API, Sterile fill finish, Analytical Development and Validation for the manufacturing site. Dr. Jones received his PhD in solid state physics from King’s College London and has previously worked in the chemical and aerospace industries.

    Alexander Stoll

    VP Competence Center Microbiology & Aseptic Technique, Fresenius Kabi AB
    Alexander Stoll

    Born in Germany, Alexander completed his PhD thesis in Microbiology in 2001. After moving to Sweden, he started working for Fresenius Kabi sterile international manufacturing plant in Uppsala. Throughout the years Alexander has been holding different management positions for the Swedish manufacturing plants within QA/QC and as QP. Starting 2012 he had responsibility as a Global Operations QA head, with regional QA and plant QA functions reporting to him. In his current position as VP Competence Center Microbiology & Aseptic Technique he has built a group of subject matter experts working with all manufacturing and compounding sites, setting global standards.

    Andrew Hopkins

    Director Audit Readiness, Abbvie
    Andrew  Hopkins

    Andrew was has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years
    Currently Andrew is a Director of audit readiness, the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.
    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years. This role included:
    • Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
    • Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
    • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
    • Inspector training and mentoring
    • Taking part in the writing of regulatory guidance documents including:
    o MHRAs Data Integrity guidance
    o EMA guidance on water systems
    o Chair for the working group for the revision of Annex 1
    o MHRA blog regarding the fragility of VHP
    • Supporting external industry bodies with technical monographs such as PDA TR1 and PHSS TM20.
    Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.
     

    Andrew Hopkins

    Director Audit Readiness, Abbvie
    Andrew  Hopkins

    Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years
    Currently Andrew is a Director of audit readiness, the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.
    Prior to this Andrew was an Inspector with the MHRA for nearly 14 years. This role included:
         • Routine (and less routine!) inspections across the world, including joint inspections with a number of other regulators (USFDA, TGA, TFDA and Health Canada) in a number of technical areas including, sterile products, biological products, blood components and plasma.
         • Chairperson of the Inspectorates Compliance Management Team (working with marginally compliant companies to support them back to full compliance)
         • Part of the MHRAs inspection Action Group (taking actions regarding non-compliant sites)
         • Inspector training and mentoring
         • Taking part in the writing of regulatory guidance documents including:
              o MHRAs Data Integrity guidance
              o EMA guidance on water systems
              o Chair for the working group for the revision of Annex 1
              o MHRA blog regarding the fragility of VHP
         • Supporting external industry bodies with technical monographs such as PDA TR1 and PHSS TM20.
    Prior to joining the MHRA Andrew worked for more than 20 years in a number of different areas and technologies in the Pharmaceutical industry. These included QA, Validation and Production Management in both sterile and non-sterile manufacturing facilities.
     

    Dan O'Mahony

    Director Sterile and Validation CoE, MSD
    Dan O'Mahony

    Dan O’Mahony graduated with a MSc in Biopharmaceutical Science and has over thirty years’ experience leading roles in quality and sterile operations, providing technical / validation support to manufacturing of vaccines, biologics, and pharmaceuticals products. Dan is currently a Director in the Global Sterile / Validation Center of Excellence at Merck Sharpe & Dhome, supporting a global network of Drug Product & Drug Substance sites in areas of aseptic processing and pharmaceutical manufacturing microbial control.

    Dan O'Mahony

    Director, Sterile & Validation CoE, Global Technical Operations, MSD
    Dan O'Mahony

    Dan O’Mahony graduated with a MSc in Biopharmaceutical Science and has over thirty years’ experience leading roles in quality and sterile operations, providing technical / validation support to manufacturing of vaccines, biologics, and pharmaceuticals products. Dan is currently a Director in the Global Sterile / Validation Center of Excellence at Merck Sharpe & Dhome, supporting a global network of Drug Product & Drug Substance sites in areas of aseptic processing and pharmaceutical manufacturing microbial control.

     

    David Phasey

    Projects Director, 3P innovation
    David Phasey

    David joined 3P in 2010 as a Project Development Engineer joining a growing team to help develop automation for a novel healthcare device. In the subsequent 10 years, David has risen to Projects Director, delivering projects across a spectrum of industries, each of which has contributed to the development of 3P’s range of platform of technologies. This breadth of experience has enabled David to develop a valuable set of capabilities across manufacturing processes such a novel vaccine delivery and ATMPs, with a specialist knowledge of sterile manufacturing.

    Declan O'Shea

    Technical Sales Manager, ILC Dover
    Declan O'Shea

    Declan O’Shea works for ILC Dover LP as the Product Manager for Isolator and Containment systems. He handles the day-to-day operation and governance of ILC Dover’s comprehensive isolator and flexible film enclosure portfolio including numerous new product developments. Most recently he has driven the development and introduction of ILC Dover’s new soloPURE, sterile manufacturing isolator. Declan is an SME for both Pharmaceutical and Bio-Pharmaceutical isolator systems and often consults on the most effective form of containment for various workflows.

    Di Morris

    Senior Lead 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.

    James Drinkwater

    Chairman of PHSS and Head of GMP Compliance F Ziel GmbH, PHSS: Pharmaceutical & Healthcare Sciences Society
    James Drinkwater

    Together with the role at F Ziel James is the elected Head of the Not-for-Profit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing and Containment special interest groups. James is a Pharmaceutical process engineer with additional education in Pharmaceutical microbiology. Working experience includes 10 years in radio pharmaceutical manufacturing and over 20 years working in sterile product manufacturing support where increasingly aseptic processing applies. James is 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).

    James Polarine Jr

    Senior Global Technical Service Manager, Steris Corporation
    James Polarine Jr

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

    Kevin Jenkins

    Consultant, Quality Excellence Consulting LLC
    Kevin Jenkins

    Kevin joined Pfizer through the Upjohn Company in 1983 as a Research Chemist in Kalamazoo, MI. He held positions of increasing responsibility in aseptic operations and, in 1996, was named Laboratory Supervisor. In 1998, Kevin accepted an international assignment as the Corporate Compliance Professional in Halden, Norway, where he prepared the IV bag facility for the first FDA Pre-Approval Inspection.

    Kevin returned to Kalamazoo in 1999 as the Director Validation/Compliance. In 2003, he moved to Terre Haute, IN, and was appointed Director Quality Operations. Kevin transitioned into a technical services position in 2007, leading product development for aseptic and inhalation products. Kevin moved to Lincoln, NE in 2008, and was appointed Director, leading the site Lean Manufacturing, Continuous Improvement and Six Sigma programs. In 2009, he was appointed Director, Quality Operations, responsible for Vaccine/Biologics Animal Health Quality. Kevin returned to Kalamazoo in 2010, as Director, Quality Operations for the site. Between 2012 - 2018, he held senior quality leadership positions: Vice President, Global Quality; VP, Global Aseptic Quality; and VP Quality Excellence. In 2018, Kevin was appointed VP Sterile Injectables Quality with responsibility for twelve plants worldwide.

    Kevin retired from Pfizer October 2019 after 36 years. He is currently a consultant with Quality Excellence Consulting LLC.

     

    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 text books in the field of cleanroom technology.

    Mauro Giusti

    Advisor, Site External Network, Eli Lilly Italia
    Mauro Giusti

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence, he is Board Certified by National Chemist association and he is Board certified as Technical Director (Qualified Person) by the Italian Minister of Health.
    After completion of mandatory military service as Army Officer, he joined Eli Lilly at the Italy manufacturing plant site in 1988. Over the 32 years with Eli Lilly, Dr. Giusti has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, Quality Control, Quality Assurance, Production of oral and parenteral products, Technical Director/Qualified Person, Six Sigma Champion. Manufacturing Science and Technology, Manufacturing Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.
    Among the several experiences with Lilly, he has worked approximately 5 years outside of Italy, both in United States (2.5 yrs, from 1992 to 1994) and in United Kingdom (2.5 yrs, from 1997 to 1999).
    Since late 2003, with the Lilly Italia mission change from Sterile and Oral cephalosporin to Insulin/Biotech products, he has had responsibility for Lilly Italy TSMS (Technical Svcs/Mfg Science Department), with responsibility for Metrology, C&Q of facilities, utilities and equipment, Sterility Assurance, Process Validation, set-up of new manufacturing processes and of new manufacturing technology for Biotech products, including automatic assembly of disposable Insulin pens and Autoinjectors. In September 2009 he also added to his TSMS duties, the responsibility for Manufacturing Sourcing and Vendor Management.
    In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (especially Universities) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.
    For more than 12 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as speaker and as chairman. In November 2019 he has been appointed as Co- Chair for he Process Validation Interest Group. In August 2020 he has been appointed to the PDA Science Advisory Board (SAB)
     

    Mauro Giusti

    Advisor, Site External Network, Eli Lilly Italia
    Mauro Giusti

    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.

    Scott Nichols

    Quality Compliance Lead, Kite Pharma
    Scott Nichols

    Scott Nichols graduated from the University of Iowa with an Honors BS in Biochemistry and continued as a Fulbright Scholar at the Pasteur Institute. His Ph.D. was earned in Molecular Biophysics at Johns Hopkins University. Following graduate school, he worked as a Quality Assessment Lead in the Division of Biotechnology Manufacturing at the FDA. He has expertise in the microbial control and sterility assurance review of biotechnology drug substance and drug product applications, and he has led multidisciplinary inspection teams of the associated manufacturing facilities. While at FDA he was an author of PDA’s Technical Report No. 82 on Low Endotoxin Recovery and worked on the review of microbial control strategies for emerging technologies. He has consulted on contamination control, sterility assurance, and regulatory CMC aspects of vaccines and cell therapy products. He now works at Kite as the Quality Compliance Lead of a recently constructed CAR-T manufacturing facility.

    Sebastian Scheler

    Chief Methodologist, Innerspace GmbH
    Sebastian Scheler

    Sebastian Scheler is co-founder and chief methodologist of Innerspace, a provider of virtual reality simulators specializing in pharmaceutical manufacturing. Scheler is a psychologist by profession and has many years of experience in psychological training and methodology development. At Innerspace, Scheler is responsible for simulator methodology and business relations with international clients in the pharmaceutical industry. He is also a speaker at numerous professional events and an active member of the ISPE Pharma 4.0 working group.

    Stijn Vissers

    Director Sterile Operations, Organon
    Stijn Vissers

    Married and proud father of 4 children. I love spending time with my family, doing sports and travelling. I have an Industrial Pharmacist and MBA degree. My current role is Head of Sterile Operations for Organon. I have more than 15 years of experience in the pharmaceutical and biotechnology industry in different areas. I started my career as validation engineer and had several management roles in technical services, operations, quality (QP) and lean/6-sigma for Schering-Plough and later MSD. I also worked in several global support groups for UCB and GSK Vaccines. I have a broad experience within sterile operations.
     

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    Preliminary Attendees List 2021

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    Chair Letter

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    Speaker Interview with Kevin Jenkins, Quality Excellence Consulting LLC

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    Speaker Interview with Dan O'Mahony, Merck & Co

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    Speaker Interview Stijn Vissers, Organon

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    Speaker Interview Mauro Giusti, Eli Lilly Italia

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    Speaker Interview with Alexander Stoll, Fresenius Kabi

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    Speaker Interview with Aled Jones, Global MST Teva Pharmaceuticals

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    Speaker Interview with Richard Denk, SKAN AG

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    Speaker Bios

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    Short Programme

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    Full Programme

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    Brochure

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    Past Attendees List

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    Sponsors


    3P innovation

    Sponsors
    https://www.3pinnovation.com

    3P innovation is an engineering and custom automation company. They work collaboratively with pharma and medical device businesses to help develop new products, devices and production processes. 3P specialises in aseptic automation and powder/liquid filling technologies. The company designs and builds scalable production solutions - supporting from lab-scale/bench top equipment to pilot plant and full production systems.

    They are active in the cell and gene sector, parenterals, reconstitution devices, inhalers and sustained release drug products.

    To experience 3P's technologies in hyper-realistic 3D, copy this link and paste it into your browser: https://www.3pinnovation.com/media-events/virtual-showroom



    ILC Dover

    Sponsors
    https://www.ilcdover.com/

    Trusted by major players in HP API & ADC development, Solo bring high performance containment solutions in innovative single use packages. Solo’s solutions include toxin-linker compounding as well as NCE molecule development isolators and now extend to Grade A aseptic fill/finish isolators – all supported by validation documentation and containment performance testing.


    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.

    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.


    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!


    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.

    Media Partners


    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.


    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

    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/



    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.


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    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.


    Rapid Microbiology.com

    Supporters
    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.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

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


    World Pharma News

    Supporters
    http://www.worldpharmanews.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

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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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    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
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