PharmaTechnica - GMP OnlineForum

Here you will find video presentations that will be made available online in the run-up to PharmaTechnica 2024. Take the opportunity to inform yourself comprehensively about new developments in the field of GMP-compliant manufacturing of pharmaceuticals. To get to these video presentations, simply complete the form below, and you will receive a link to the videos to the e-mail address you entered.

Currently you will find the following presentation in the PharmaTechnica Online Forum:

Climate Conditioning of highly toxic APIs. Experience Safety.
Henning Falck, Weiss Pharmatechnik

  • Idea of a Climatic Chamber inside an Isolator Application
  • Challenges for a GMP Compliant Integration
  • Operation

Dual-Mode Isolator System
John Williams, Product Manager, Telstar

  • Merging aseptic and containment modes
  • Flexible design explanation
  • Cost effective approach
  • Pharma equipment industry standards compliance

Risk Assessment in Contamination Control
Arjan Langen, Sterility Assurance Director, GE Healthcare

  • Relevant Guidelines – e.g. ICH Q9, WHO and MHRA
  • Tools for Risk Assessments – FMEA and HACCP
  • Risk Registers – Identify, Evaluate and Communicate Potential Quality Impact
  • Risk Management in Contamination Control

Self-calibrating Temperature Measurement according to FDA and ISPE GAMP
Dietmar Saecker, Senior Product and Application Expert

In the majority of pharmaceutical plants, measuring devices are removed and calibrated at fixed points in time. Since 2011, the US Food and Drug Administration (FDA) and the International Society for Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practices (GAMP) rules have required continuous process monitoring and advocated risk-based calibration management. With temperature making up a large part of critical measuring devices we present ways to integrate self-calibrating/self-verifying temperature measurement devices into existing plants.

Contamination Control Strategy - Inspector´s View on an Overarching Strategy
Dr Rainer Gnibl, GMP Inspector for EMA and local Government, Germany

  • Requirements
  • Expectations & Interpretations

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