Cleaning and Sterilisation processes

Sponsored by
       

Summit description

Cleaning and Sterilisation processes related to production equipment need to meet the standards of the authorities where the control and reduction of chemical, microbial, particulate and endotoxin/pyrogen contamination is considered important. Any contamination control strategy requires an evaluation of these controls based on risk and risk assessment.
Whether you work with Pharmaceuticals or Medical Devices, you are witness to a raised focus in respect to Cleaning and Sterilisation processes. This 2-day summit in Copenhagen, Denmark brings Cleaning and Sterilisation processes to you with multiple expert competences, including Quality Assurance experts, Global Task Force Standard contributors and high-level consultants. And on top of this, you will have the opportunity to link up and network with industry peers.

Conference outline

Day 1 

• Why a robust cleaning process before is essential for the success of the Sterilisation one?!
  Laurent Merli
• Risk-Based Cleaning Validation, Carry Over and Process Automation
  Susan B. Cleary
• Sustainable Cleaning Validation
  Kenneth Farrugia
• Case studies on common cleaning mistakes and enablers for cleaning improvement
  Walid El Azab
• Monitoring and trending of cleaning data
  Mohammad Ovais
• Improving quality of Health Based Exposure Limits (HBELs). Current best practices based on guidance by EMA, PIC/S and ASTM Standard E-3219
  Dr. Andreas Flückiger
• Workshops (Parallell)
  • Statistical Analysis in Recovery Studies
    Speaker: Ioanna-Maria Gerostathi
  • Sterilization and Annex 1 – the elements to consider in CCS for sterilization processes
    Speaker: Tony Christensen & Juha Mattila
• Networking, mingling and snacks  (Compliments of sponsor)

Day 2

• Creating a robust Cleaning Protocol and Report
• Top 10 inspection findings associated with Sterilization and Depyrogenation Processes
  Mark Thompson
• Joe Cagnassola
• Use of statistics including treatment of censored data in Lifecycle Cleaning Validation as prescribed by ASTM E3106
  Igor Gorsky
• Development and validation of an analytical method for cleaning validation: Tips & Tricks
  Solenn Janvier
• New Product Development; Defining and justifying the approach to sterilisation
  Mark Thompson
• Plenary Q&A

What will you learn – Take-Aways?

Training take-aways will include Annex 1 updates, HBEL Calculations, Applied Statistics, Analytical Method Validation Approaches, Protocol Development, execution, and reporting.
Special workshops will be included on Day 1 aligned with speeches on the same day. The full list can be seen in the detailed agenda.

Who is it relevant for?

Whether you or your team work with Quality Assurance, Quality Control, development, Validation or production related to Cleaning and Sterilisation processes, this summit will add value to you.
You could work as eg. a Chemist, Production Supporter, Quality Controller, or in Regulatory Affairs – and no matter if you are a Subject Matter Expert or the decision making manager, you will find exciting lectures and cutting-edge information.

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