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The SMi Group is pleased to invite you to the inaugural
Aseptic Processing Conference
NEW DATES 20th - 21st September, 2021 | London, United Kingdom
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The Aseptic processing industry has seen consistent growth in recent years -- with advances in innovative therapeutics, new practices and personnel protocols, robotics and automation in filling lines, and more rapid microbiological methods being just a few of the factors driving this growth. As of 2020, the Global Aseptic Processing Market is projected to reach $73 Billion by 2027.

 
The industry is also seeing crucial changes in 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 novel tools and technologies pushing innovation in the world of aseptic processing and sterile manufacturing.
 

 

DISCUSS the revisions and the impact of Annex 1 on aseptic manufacturing with AstraZeneca
LISTEN to a field report on the implementation of a global contamination control program with Takeda
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
Senior Microbiologists
Quality Control Managers
Heads of GMP Compliance
Quality Assurance Experts
Technical Operations Leads
Leaders in Sterility Assurance
Cleanroom Managers
Regulatory Affairs Managers
Production Managers
Quality Systems Managers
Heads of Quality Compliance
Process Leaders
Senior Auditors
 

 

Amneal Pharmaceutical; Amneal Pharmaceuticals LLC; Analytical Lab Group LLC; Associates of Cape Cod; Association of Cape Cod, Inc; Atara Biotherapeutics; Banelle; Baxter Corporation; bioMerieux Industry; bioMerieux, Inc.; Bioscience International; BioTekPro AB; Biotherpeutics; BioVigilant Systems; Bristol Myers Squibb; Charles River; CTL - Mat; DuPont; DuPont de Nemours Luxembourg sarl; Dupont Personal Protection; Eagle Analytical Services (Former FDA); Eli Lilly And Company; Emergent Biosolutions; Genentech; ImmuneBiotech AB; Infinity Laboratories; InnovaPrep; International Serum Industry Association; Ipsen; Lantheus Medical Imaging; Lonza; Lonza Walkersville, Inc.; Merck; Meridian Medical Technologies; Mettler Toledo; Microbiological Consulting, LLC; Microrite, Inc.; Novartis Pharmaceuticals Corporation; Novatek International; Ocular Therapeutix; Organogenesis Holdings Incorporated; Pfizer; Pfizer Inc; Pharmaceutical and Healthcare Sciences Society; Pharmalucence, Inc.; Regeneron; Regeneron Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme; SCA Pharma; Seres Therapeutics; Steris Corporation; Sun Pharma Boston; Takeda; Takeda Pharmaceuticals; United Therapeutics; University Of Calgary; University Of Guelph; University of Veterinary Medicine Vienna; Vericel Corporation; Zeteo Tech LLC;

 

Conference programme

8:00 Registration & Coffee

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 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

9:50 FDA’s current expectations on sterile biotechnology drug product manufacturing

Scott Nichols

Scott Nichols, Quality Compliance Lead, Kite Pharma
View Bio

• FDA’s regulatory framework relating to Aseptic Processing
• Discussion of common review/filing issues relating to sterility assurance
• Outcomes from GMP inspections
 

10:30 Aseptic manufacturing inside a single use, disposable isolator

Declan O'Shea

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

• Development of a true single use, aseptic disposable isolator
• How Gamma Irradiation works so well as a sterilisation method for flexible film isolators
• Prototypes: How creating and developing many working prototypes with customers benefits both parties.
• Advantages of working with flexible film isolator systems
 

11:10 Morning Coffee

11:40 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
 

12:20 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
 

13:00 Networking Lunch

14:00 Implementation of a global contamination control program – A field report

Christoph Hansy

Christoph Hansy, Associate Director, Takeda
View Bio

• Overview: From the idea to the roll out of a global contamination control program (CCP)
• Contamination control program key elements and documents
• Current status / sustain phase of the contamination control program
 

14:40 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
 

15:20 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

 

16:00 Afternoon Tea

16:30 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
 

17:10 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
 

17:50 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 & Coffee

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 Coffee

11:00 Cleanroom DeepTraining – possibilities and frontiers of Virtual Reality

Sebastian Scheler

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

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

 

11:40 Aseptic Competence at Fresenius Kabi – Case studies of Fresenius Kabi´s global aseptic manufacturing

Benedikt Reichart

Benedikt Reichart, Global Business Development Manager, Fresenius Kabi Austria GmbH
View Bio

• Aseptic competence at Fresenius Kabi for a broad variety of containers
• Case studies of our main facilities including mixed views on operator/processes, isolator/equipment and a short outlook on the processing of pre-filled syringes under aseptic conditions.
        o Graz, Austria
        o Melrose Park, US
        o Wilson, US

 

12:20 Networking Lunch

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 The trend towards custom automation in response to the macro trends in the aseptic automation sector

David Phasey

David Phasey, Projects Director, 3P innovation
View Bio

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

14:40 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
 

15:20 Afternoon Tea

15:50 Designing a quality management system (QMS) for ATMP manufacturing

Jingjing Li

Jingjing Li, Senior Manager, QA, Orchard Therapeutics
View Bio

• Reviewing the elements of a QMS for ATMP manufacturing
• Integrating contamination control into the QMS
• Aligning QMS with operational models
• Managing QMS lifecycle
 

16:30 AAV Manufacture and Drug Delivery - Gene Therapy Moving from Small to Large Patient Populations

Ian Pitfield

Ian Pitfield, SVP Technical Operations, Gyroscope Therapeutics
View Bio

• AAV gene therapy process development
• Analytical development and product characterisation
• Technology transfer and GMP manufacture
• Formulation, supply chain and drug delivery
 

17:10 Chair’s Closing Remarks and Close of Day Two

Richard Denk

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

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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
Benedikt Reichart

Benedikt Reichart

Global Business Development Manager, Fresenius Kabi Austria GmbH
Christoph Hansy

Christoph Hansy

Associate Director, Takeda
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
Ian Pitfield

Ian Pitfield

SVP Technical Operations, Gyroscope Therapeutics
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
Jingjing Li

Jingjing Li

Senior Manager, QA, Orchard Therapeutics
Kevin Jenkins

Kevin Jenkins

Consultant, Quality Excellence Consulting LLC
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 and Co-Founder, Innerspace GmbH
Stijn Vissers

Stijn Vissers

Director Sterile Operations, Organon

Aaron Mertens

Technical Service Specialist, Steris Corporation
Aaron Mertens

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 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.
 

Benedikt Reichart

Global Business Development Manager, Fresenius Kabi Austria GmbH
Benedikt Reichart

Benedikt acts as the first point of contact for pharmaceutical companies planning the outsourcing of manufacturing of sterile liquid pharmaceuticals at Fresenius Kabi’s manufacturing sites in Europe and Asia. Benedikt joined Fresenius Kabi as a Management Trainee after completing his PhD in Organic Chemistry from the Karl-Franzens University of Graz, Austria in 2014. He afterwards covered the role of executive assistant at Fresenius Kabi focusing on pharmaceutical manufacturing, global investments, strategy roll-out, capacity and supply chain management.

Christoph Hansy

Associate Director, Takeda
Christoph Hansy

Christoph Hansy has more than 13 years of experience in the pharmaceutical industry. He is currently member of the Global Microbiology Management Team at Takeda and based in Vienna, Austria.
In his current role he provides subject matter expertise as well as technical leadership on microbiological matters, such as method related projects, microbial control strategies, and contamination/investigation support in a global role. During his career he has undergone several company integration programs and was therefore able to gather multiple insights in different contamination/microbiological control strategies.
Since 2017 he is involved in the development, implementation and sustain phases of a global contamination control program.

 

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

Solo Containment are leading the field in new Sterile Isolator innovations with single use Aseptic processing systems. Demand for rapid setup for small, handfill batch production has increased and with the added convenience of zero cleaning validation required on the single use system the soloPURE isolator has proven a popular choice for CDMO operations.
We shall be presenting a White Paper on the development of this unique isolator system and deduce the challenges overcome during its creation and qualification.
 

Dermot O'Riordan

Business Development Manager, EirGen Pharma Ltd
Dermot O'Riordan

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.

Ian Pitfield

SVP Technical Operations, Gyroscope Therapeutics
Ian Pitfield

Ian graduated from the University of Cambridge in 1992 with a PhD in Biotechnology. After a short period working for SAF developing downstream processes for high value, low volume products, Ian moved to SmithKline Beecham/GlaxoSmithKline to start a 17-year Analytical Scientist/Management career in Pharmaceutical Drug development. From June 2012, Ian transitioned to CMC Project Leadership in GSK’s Cell and Gene Therapy team leading CMC development, validation and regulatory submission of Strimvelis, the world’s first approved ex-vivo autologous gene therapy. Ian started as VP, CMC at Gyroscope Therapeutics in January 2017.

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.

Jingjing Li

Senior Manager, QA, Orchard Therapeutics
Jingjing Li

Jing’s professional experience spans across Europe, Asia and North America, in industries including ATMP, bio-pharma and medical devices. Her focus for the most recent five years has been ATMP operations and quality assurance. At Lonza Singapore, she managed the cell therapy operations team with manufacturing activities seven days a week. At the Cell and Gene Therapy Catapult Stevenage Manufacturing Centre, she led the QA team and worked cross-functionally to build a fit-for-purpose quality management system, which resulted in successful facility GMP licensure. Currently Jing is with Orchard Therapeutics providing QA guidance to the CMC Technical Operations team across various programmes.

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.

 

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 therpay products. He now works at Kite as the Quality Compliance Lead of a recently constructed CAR-T manufacturing facility.

Sebastian Scheler

Chief Methodologist and Co-Founder, Innerspace GmbH
Sebastian Scheler

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

Serena Ambrosini

Sterile Manufacturing Manager, AstraZeneca
Serena Ambrosini

Serena Ambrosini has a MSc in Pharmaceutical Chemistry (2007) and a PhD in Analytical Chemistry (2010). After her academic studies she has specialized in aseptic manufacturing, heat sterilization and VHP decontamination. Serena has worked in Fedegari and GSK in Italy and she currently holds the position of Sterile manufacturing Manager in AstraZeneca (UK). She is accountable for and lead improvement projects to deliver enhanced sterility assurance and to develop a robust sterility assurance business process and strategy (e.g. optimisation of the cleanroom processes and steriliser validation, implementation of VHP in cRABS and transfer hatch).

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.
 

Ulrich Kissel

Founder, CEO and Consultant, KisselPharmaConsulting GmbH
Ulrich Kissel

With more than 25 years experience in the Pharma industry Ulrich Kissel is today running his own consultancy company with focus on GMP systems. Before he was more than 20 years in Roche (Switzerland, Germany) holding various managerial positions in Quality and Supply Chain Management including 10 years in the role of a Qualified Person for marketed and clinical products with focus on biotechnology. He serves as chairman to the European QP Association with more than 3000 members within all EU member states and beyond. Ulrich is pharmacist with an Ph.D. in biochemistry.

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Workshops

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

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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.

Exhibitors


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


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.


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


World Pharma News

Supporters
http://www.worldpharmanews.com/



MedTube

Supporters
https://medtube.net/



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


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.


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.


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


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.


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.


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.

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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.

 

HOTEL BOOKING FORM

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WHAT IS CPD?

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

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

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

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

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

CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

GLOBAL CPD

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

CPD Certificates

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

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