Presented by
Management Forum
Pre-Filled Syringes: End-to-End Processing Training Course
Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
★★★★★ "It was very good, I was impressed, I would have loved to do this course in person but this was a goo... more"
30-31 March 2023
+ 2 more dates
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course overview
This intensive two-day course has been designed to offer a comprehensive, practical, and usable review of the production of PFS and will provide the latest information on all aspects of the process from manufacture and packaging for fill/finish through to final (post-fill) inspection. Quality will be a key focus of the programme and there will be extensive coverage of improvements in the manufacturing process, including advances in cleanroom technology and sterilisation. Other sessions will address visual inspection and the latest regulatory requirements to ensure that you are fully up to date. The faculty of speakers will provide key guidance and advice from their practical experience in this field and there will be ample opportunity for discussion.
Who should attend?
This event is ideal for pharma start-ups, small and medium-sized pharma companies, CROs, CMOs, machine suppliers, hospital dispensaries, and anyone new to PFS or wanting to learn more in a relaxed and open environment. It will be of value to those working in the area of PFS with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance and combination products. Drug delivery specialists, business development managers and product development managers will also find this course beneficial.
The Pre-Filled Syringes: End-to-End Processing course will cover:
Syringe manufacture from components to the final product – an overview
- The initial choice – bulk or pre-sterilised components?
- Siliconisation – not beloved, but required
- Handling and process overview
PFS over time
- Evolution of systems
- Evolution of components
- Evolution of application and application systems
Summing-up: Trends in PFS: Drug Delivery
- New PFS formats
- Safety devices
- Self-injection devices
Advances in cleanroom technology
- History
- RABS
- Isolator
- V-CRT® - Vetter Clean-Room Technology
Filling and closing: multi-format machine for nested syringes, vials and cartridges
- Dosing and filling systems in comparison
- Closing methods and their applications
- Containment
Terminal sterilisation of pre-filled syringes – strange but feasible
- Points to consider
- Aseptic filling vs terminally sterilised
Summing-up: Trends in PFS: Machine Technology
- Pumps ‘fit for purpose’
- In Process Control (IPC), filling & stoppering
- Robotics
Visual inspection of pre-filled syringes
- Why do we inspect? Regulatory requirements
- Inspection basics
- Defects – classification and defect evaluation lists
- Pros and cons of different inspection methods
- Automated visual inspection of syringes – scope and limitations
- Current developments
Secondary packaging machines for PFS: hero or villain of the PFS world?
- Walk through a typical facility
- Trends in secondary packaging: labelling, safety devices
- Single machines v’s combined machines
Autoinjectors
- Target Product Process
- Impact Primary packaging material
- Assembling steps
- Inline Controls
- Function / Release Tests
- Final Packaging
Regulatory requirements for pre-filled syringes
- ISO design compliance
- New MDR – what about it?
- US requirements for combination products
Case study/workshop
Based on the key user requirements provided, participants will come up with outputs for:
- Design features of the PFS
- Test methods
- Manufacturing processes and manufacturing environment
Shipping PFSs all over the world
- Points to consider
- Shipping validation
- GDP - Good Distribution Practices
PFS state-of-the-union address and event summary
- Review of market drivers & drug development
- Future trends in PFS
30-31 Mar 2023
27-28 Jul 2023
8-9 Nov 2023
Dale Charlton
DCBio Automation SIA
Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D at a major University and EMBL Heidelberg before embarking on a more formal academic career in biotechnology and studying for a PhD within the Drug Discovery Group of Pfizer into growth factor research (rGH, GHRF, IgF) . With industrial spells at Porton Down and Pittman-Moore (formerly Glaxo Animal Vaccines) in API and API scale-up, Dale settled back into biotech manufacture and moved more into the supply chain of finished drug products for small molecules & biologics, first as the MD of a life sciences distribution company and later as Director of Business Development, Optima pharma in sterile production automation. Having worked in the pharmaceutical industry from R&D to finished drug product, Dale has a unique understanding of the entire drug development life cycle and offers insight from both the pharma and a suppliers perspective.
30-31 Mar 2023
Dave Rushton
Paradigm Shift Consulting
Dave Rushton is the Founder of Paradigm Shift Consulting, an ISO 9001: 2015 accredited company for training and quality management services to the pharmaceutical industry.
Paradigm Shift Consulting are GDP experts, Cogent assured trainers and CPD members, and specialise in obtaining and retaining wholesale distribution authorisations, remediation work, training, provision of Responsible Person and QA services, auditing, supported self-inspections and lane and route validation.
Dave is a named Responsible Person, Cogent assured trainer, certified PQMS Lead Auditor, PCQI (Practitioner of the Chartered Quality Institute) and leads MHRA IAG and CMT remediation cases where sites have failed in their compliance.
30-31 Mar 2023
27-28 Jul 2023
8-9 Nov 2023
Andreas Rothmund
Vetter-Pharma
Dr. Andreas Rothmund is Qualified Person (retd) at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years.
He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.
30-31 Mar 2023
Susanne Hall
Vetter Pharma
Susanne Hall began her career in 1990 at Dr. Karl Thomae in Biberach as Head of Packaging
Technology. In 1993, she joined Vetter’s Research and Development department as Head of
Packaging Material Incoming Control and in 2008 was named Team Leader of Secondary
Packaging. Since 2019, she has been the Director of Secondary Packaging and AVI Projects. In
this position, Susanne leads three teams that ensure the implementation of customer products
from development to commercial into production. For secondary packaging this includes device
assembly, labeling and final packaging as well as implementing tests for a controlled safe
process and the meeting of customer expectations. She is also responsible for the transfer of
products from manual visual inspection to fully automated inspection lines. Susanne has a
diploma in engineering from the College of Engineering where she focused on specialized
precision engineering.
Book Pre-Filled Syringes: End-to-End Processing Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
30-31 March 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12557
- GBP 1,299
- EUR 1,869
- USD 2,129
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
27-28 July 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12558
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 22 Jun
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
8-9 November 2023
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12664
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 04 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Pre-Filled Syringes: End-to-End Processing training course
It was very good, I was impressed, I would have loved to do this course in person but this was a good alternative.
The speakers were very good, very knowledgeable but also good at teaching/ relating information. The presentations were easy to follow, it was useful to have the documents there to follow along as the speakers talked. All the content was relevant to the topic and occasional humus.
I enjoyed the course and would recommend Management Forum to my colleagues.
Mar 30 2022
Zhané Healey 
Senior Laboratory Technician, Medical Engineering Technologies
Mar 27 2019
Very knowledgeable and helped answer numerous questions. Very helpful and interested in individual challenges.
Gabrielle Kelsey
Production Manager, Torbay Pharmaceuticals
Mar 20 2017
Very informative, good overview of PFS development. Speakers were knowledgeable.
William Turner 
Associate Bioedical Engineer, Meridian Medical Technologies, a Pfizer Company
Mar 20 2017
Friendly, knowledgeable people. I would have liked to go a bit deeper into the technical parts (syringes, tubs, machines)
Marc van Nispen 
Project Engineer, EMCM B.V.
United Kingdom
- 3P Innovation Ltd
- 42 Technology Ltd
- Archimedes Pharma Ltd
- Astech Projects Limited
- ASTECH PROJECTS LTD
- AstraZeneca
- Becton Dickinson UK Ltd (Oxford)
- Bespak Europe Ltd
- Calea UK Ltd
- Cambridge Design Partnership
- Cardinal Health
- Catalent Pharma Solutions
- Ethypharm
- Future Injection Technologies Limited
- GlaxoSmithKline
- Glide Pharmaceutical Technologies Limited
- Harro Hoefliger Packaging Systems Ltd
- IT Pharma
- Martindale Pharma
- Medical Engineering Technologies
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- OnDrugDelivery Ltd
- Oval Medical Technologies Ltd
- Owen Mumford Ltd
- QRC Consultants Ltd
- Salvus Technology Limited
- Sanofi-Aventis
- Team Consulting Ltd
- Technology Partnership Plc
- Terry Weston
- Teva Pharmaceuticals Europe B.V.
- Tip-top.com Limited
- Torbay Pharmaceuticals
- UCB Celltech
- ViiV Healthcare
- West Pharmaceutical Services
- West Pharmaceutical Services Cornwall Ltd
- Wyeth Pharmaceuticals
Germany
- Abbott Products GmbH
- B Braun Melsungen AG
- Bayer Pharma AG
- Gerresheimer Bunde GmbH
- Medac GmbH
- Nipro Glass Germany AG
- Optima Group pharma
- Rexam Pharma GmbH
- Robert Bosch GmbH
- RPC Formatec GmbH
- Sanofi-Aventis Deutschland GmbH
- Schott AG
- Schreiner Group GmbH & Co KG
- Vetter Pharma International GmbH
United States of America
- Abbott Laboratories
- Advanced Electron Beams
- Alexion Pharmaceuticals Inc
- AMGEN INC
- BD
- Eli Lilly and Company
- Genetech Inc
- IDEO
- Meridian Medical Technologies Inc
- Meridian Medical Technologies, a Pfizer Company
- NA
- Portal Instruments
- Regeneron Pharmaceuticals, Inc.
- West Pharmaceutical Services Inc.
Switzerland
- Actelion Pharmaceutical Ltd
- CSL Behring AG
- F. Hoffmann-La Roche Ltd
- Forteq Healthcare
- Geistlich Pharma AG
- Haselmeier GmbH
- Komax Systems LCF SA
- Merck
- Mikron SA Boudry
- Novartis Pharma AG
- Schott Schweiz AG
- Ypsomed AG
France
- Aptar Pharma
- BD Medical – Pharmaceutical Systems
- Becton Dickinson
- BIOCORP
- Cabinet Michel Richebourg
- Guerbet
- Linac Technologies
- RUMPLER TECHNOLOGIES
- Stelmi SA
Netherlands
- Amgen Europe BV
- Bilthoven Biologicals BV
- EMCM B.V.
- Interdos Pharma B.V.
- MSD B.V.
- MSD/NV Organon
- Sever Pharma Solutions
- Synthon Biopharmaceuticals BV
Israel
- Elcam Medical Ltd
- Flextronics Design srl
- Sindolor Medical Ltd
- Teva Pharmaceutical Industry Limited
- Teva Pharmaceuticals Industries Ltd
- West-Medimop
Sweden
- Apotek Produktion & Laboratorier AB
- Apoteket Produktion & Laboratorier AB
- BD Medical - Pharmaceutical Systems
- BECTON DICKINSON AB
- Q-Med AB
- UPPSALA UNIVERSITY HOSPITAL
Austria
- Baxter Innovations GmbH
- BD Medical - Pharmaceutical Systems
- EBEWE Pharma
- Sandoz GmbH
- Takeda Austria GmbH
Denmark
- ALK-Abello A/S
- Bang & Olufsen Medicom AS
- Ferring Pharmaceuticals A/S
- LEO Pharma
- Novo Nordisk A/S
Belgium
- Baxter R&D Europe
- Datwyler Pharma Packaging Belgium NV
- Glaxo Smithkline Biologicals
- Toxikon Europe NV
Ireland
- Crospon Limited
- ENTERPRISE IRELAND
- Tech Group Europe
Italy
- Alfa Wassermann S.p.A
- Nuova Ompi srl
- Sinclair Pharma SRL
Finland
- DelSiTech Ltd
- Phillips-Medisize
Croatia
- Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Hungary
- Gedeon Richter Plc.
India
- Piramal Healthcare Limited
Japan
- Daicel Corporation
Latvia
- DCBio Automation SIA
Spain
- Admiral S.A.
Run Pre-Filled Syringes: End-to-End Processing Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
