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PHSS Aseptic Processing Workshop Syndicates 2019
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PHSS Aseptic Processing Workshop Syndicates 2019

The PHSS are launching a new annual event with an Aseptic Processing Workshop including a series of hands on training syndicates.

 Export to Your Calendar 03/04/2019 to 04/04/2019
When: 3rd and 4th April 2019
Where: Map this event »
The Mere Resort and Spa
Chester Road
Knutsford, Cheshire  WA16 6LJ
United Kingdom
Contact: Tamsin Marshall
01793824254


Online registration is available until: 22/03/2019
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PHSS Aseptic Processing Workshop Syndicates 2019

The PHSS are launching a new annual event in Aseptic processing training with a workshop series delivered as syndicates over a two day event.

Following a key note presentation each day four Hands-on 75 min individual workshops will be provided with a total of eight practical workshops providing unique learning opportunities over the two days.


Each Aseptic process workshop is sponsored and delivered by Subject matter experts and specialists on the workshop topic.

Ahead of each workshop syndicate a key note presentation will be provided covering new technologies and challenges in GMP compliance. Workshops will cover current guidance, regulatory  expectations and supportive GMP guidance via Q&As, Blogs, Guidance notes. 

 

There is a limit of 80 attendees per day, attendees can attend all workshops over the two days or individual workshop days.

Places are going fast!

Key Note Presentations

DAY 1 : 3rd APRIL 2019 

Speaker Dr Dieter Bachmann, Director, Aseptic Processing, Johnson & Johnson, Janssen Pharmaceuticals.

Presentation: Aseptic Smart - Robotic Filling – the way of future Pharmaceutical manufacturing


Robotics and Gloveless Barriers in process filing operations – the future.
Case study Janssen and Pharma Integration Robotic – Gloveless process barrier E2E Modular Aseptic Filling line.
Considerations in GMP compliance opportunities and challenges, risk reduction in Contamination during filing, EM in Gloveless barriers, Process simulations


DAY 2 : 4th  APRIL 2019 

Speaker Gordon Farquharson, Director, Principle Consultant; Critical Systems Ltd. ISO working group leader.

Presentation: ‘’Blind compliance encourages bad science”
Some of the issues where we are tempted to ignore the benefits of technology and scientific developments because they challenge the established traditional norms written in our GMPs.
Perspective on in-direct and supportive GMP guidance from regulatory Q&As, Blogs, Industry Guidance notes that add and/or clarify GMP expectations.

 

DAY 1 : 3rd APRIL 2019
FOUR 75 MINUTE WORKSHOPS : SESSIONS START 10am

 

 

Workshop 1. Moist heat sterilization – autoclaving loads, avoiding wet loads. Considerations of Autoclave cycle design, set-up of cycle/ load, steam quality impact, air removal requirements, temperature management and load placements with impact of protective coverings. 

Sponsored by: 

 

Workshop 2. VHP/ vH2O2 applied to barrier technology, start-up loads or material transfer loads and container closure indirect product contact surfaces in Aseptic process filing including stopper feeder bowls and track-ways. Science and process knowledge to better understand strengths and limitations of VHP/ vH2O2 for improved application, prevention of over claiming effiacacy that brings regulatory challenge with consideration to ‘fragility of VHP’ outlined in MHRA Blog. Is VHP/ vH2O2 such a fragile bio-decontamination method or is the knowledge of science and process application of VHP/ vH2O2 bio-decontamination the real fragility that leads towards poor method application, poor process and GMP non-compliance? What is regulatory expectation over very limited regulatory written guidance?

Sponsored by: 

 

 

Workshop 3. Barrier Technology; Isolators and RABS: Good aseptic technique with consideration of ‘First air’ principles including Glove management via selection, integrity testing (visual and physical), response to detected leakage post filing/ aseptic process manipulations in Grade A environments.

Sponsored by: 

 

 

 

Workshop 4. Containment in GMP Aseptic processing applications considering process solutions and containment compliance challenges for API processing as ingredients of sterile aseptic processed products and Aseptic – Containment in Filling of Toxic and biologically hazardous products with Health based exposure limits.

Sponsored by: 

 

 

DAY 2 : 4th APRIL 2019
FOUR 75 MINUTE WORKSHOPS : SESSIONS START 10am


Workshop 5. Single use Technology in Aseptic processing. Design and Quality considerations. Including Product bag systems, PUPSIT systems and associated connection pathways and barrier technology interfaces.

Sponsored by: 

 

  

Workshop 6. Risk based Environmental Monitoring: Setting sample locations by review of contamination risks; considerations on Holistic EM programs and Process monitoring. Considerations on
incubation regimes. Demonstration of Rapid Micro Method surface sampling by swabs. Demonstration of Continuous Particle monitoring Contamination GMP Compliance and Event monitoring together with incidence rate trending software. 

Sponsored by: 

 

 

Workshop 7. Airflow visualisation in controlled zones: CFD (Computational Fluid Dynamics in design), Smoke visualisation studies - good practice in study design and application, LR Method with smoke particle challenge and particle counting tracking to study contamination control.

Sponsored by: 

 

  

 

Workshop 8. Manual Disinfection  compliance and application. Current perspective on impact of Annex 1 revision, Biocides directive compliance, disinfectant(s) selection and qualification, Disinfection regimes. Disinfection delivery methods and applications.Managing disinfection residues.

Sponsored by:  

For more detailed programme, Please click here for download

 

Click here for Hotel accommodation, please book early as the rooms will be released in allocation dates. 


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