Qepler | summits & conferences | Cleanroom Technology Summit, 12-13 November 2020
Event Location:
Prague, Czech Republic
Venue:
Novotel Praha Wenceslas Square Hotel Katerinska 1476/38
Date:
12 November 2020 - 13 November 2020
Language:
English

Early Bird discounts:
Register early to save € 500 for the Individual ticket, € 600 per person for 2-3 Delegates, € 700 per person for 4+ delegates from the same company until 05 June 2020.

Conference Overview

Get the latest updates in cleanroom technologies, new regulations, compliance strategies, engineering and design, EM and contamination control.

The featured talks on

  • Compliance with the regulatory standards.
  • Annex 1 and aseptic processing - compliance with the guide. Considerations for implementation. Aseptic Processing principles.
  • Annex 1 as a part of QRM: related requirements and adoption strategy.
  • GMP cleanroom classification and compliance.
  • New ISO cleanroom standards and application.
  • Preparing for regulatory inspections.
  • Technological innovations in cleanrooms.
  • Building high technology facility: improving contamination control. Effective cleanroom development, engineering and design.
  • Novel solutions for the facility design.
  • Cleanroom HVAC systems. Contamination removal. Novel technologies.
  • QbD implementation in cleanroom projects.
  • Selecting effective cleanroom clothing. Quality risk management. Clothing & PPE.
  • Contamination control through environmental monitoring.
  • Environmental qualification: operational monitoring, process simulation, media fills.
  • Risk centred environmental monitoring.
  • Contamination control program- cleaning and disinfection programs for aseptic facilities. Current regulations and guidance. Contamination control principles.
  • Risk based approach for cleaning, disinfection and sanitization. Cleaning and disinfection protocols. Identifying contamination control elements to improve manufacturing process: design, procedural, proper tools and challenges you will meet.
  • Implementing successful contamination control program: key elements and steps.
  • Boosting effectiveness of contamination control procedures.
  • Aseptic mentoring program implementation to boost manufacturing in your company.
  • Creating aseptic containment strategy for the high potent products processing.
  • Costs minimization, energy effectiveness and quality maintenance strategy.
  • Microbial contamination management.
  • Contamination monitoring.
  • Aseptic gowning: procedures, training, personnel qualification.
  • Cleanroom classes and classification.
  • Repair and maintenance technologies.
  • Cleanroom training program. Creating a quality team trainings and maintenance.

Meet our Speakers

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SNAPSHOT OF ATTENDEES

Affygility Solutions - Ardena - ARTeSYN Biosolutions - Bayer AG - Bayer Consumer Care AG - Biocon - Bristol Myers Squibb - Celgene - ChargePoint Technology Ltd - EVER Pharma Jena GmbH - Gedeon Richter - GlaxoSmithKline - Guido Maik Consulting - Hebeler Process Solution LLC - HPAPI Project Services Limited - ILC Dover - Ipsen - JLS International Germany - Krka, d.d., Novo mesto - Leeds Beckett University - Lonza - Lonza Pharma & Biotech - Lusochimica SpA - Merck Group - Minaken - Mitsui & Co. Italia S.P.A. - MSD - Novartis - Novasep - Oriento SA - Patheon, part of Thermo Fisher Scientific - Piramal Pharma Solutions - Pliva Croatia Ltd, TAPI Croatia - Praevena AG - Regeneron Pharmaceuticals, Inc - Skan AG - Takeda Ireland Limited - Umicore AG & Co KG - Others