Compliance alone is not good enough to pass inspections anymore. Instead, it's the fusion of regulatory diligence with proactive attitudes and a deep-rooted commitment to quality that convinces auditors and leads to positive inspection outcomes. But this is no easy task...
When pharmaceutical companies overlook the quality of training they provide, they inadvertently set themselves up for increased labor costs. Training programs are often seen as an area to cut costs, but this perspective is misleading and could have the opposite effect.
Raising awareness in a training context means enabling trainees to understand not just the "how" but the "why" behind actions. This allows them to act consciously, mitigate risks, and reduce procedural deviations. But, traditional training programs are notoriously bad at raising awareness.
In Pharma, deviations are a significant concern, often leading to costly consequences both in terms of product quality and compliance risks. While training is frequently pinpointed as the culprit behind these deviations, it's crucial to dissect whether it truly is the core issue or merely one element within a broader context.
Failures in aseptic production could lead to high costs, and at the extreme, harm patients' lives. With cleanroom personnel at the forefront opf potential failure, a significant focus lies on training. But what actually constitutes good training? Part 2 of our article provides 6 additional answers to this question.
Failures in aseptic production could lead to high costs, and at the extreme, harm patients' lives. With cleanroom personnel at the forefront of potential failure, there is a significant focus on training. But what actually constitutes "good training" and what are the limitations?
Traditional training methods have some inadequacies when it comes to training cleanroom personnel. Virtual Reality (VR) Simulators overcome those limitations and provide a more effective and impactful training.
The revised EU GMP Annex 1 significantly impacts cleanroom personnel training in multiple aspects. Pharmaceutical manufacturers now need to act and change their training program in order to reach compliance. This article summarizes the most important Annex 1 paragraphs that relate to cleanroom training.
Cleanroom personnel training in the pharmaceutical industry is crucial for maintaining stringent cleanliness and safety standards necessary for manufacturing sterile products. However, numerous challenges hinder the effectiveness of traditional training methods. Here are the 7 biggest problems...
January 2024, Innsbruck, Austria - Boehringer Ingelheim and Innerspace signed a deal to implement state-of-the-art Virtual Reality (VR) cleanroom training into the existing training program at Boehringers Biberach site.
