An engineer living near Berlin, pharmaceutical professional and an expert in the fields of medical devices, combination products, and pharmaceutical packaging.
Combination Products: A global overview of regulations for innovative drug-device combinations, streamlining market authorizations and ensuring patient safety.…
Understanding the shelf-life of pharmaceutical packaging is critical for safety and compliance. It involves categorization, defining total shelf-life, deciding on re-examination, and re-testing considerations.…
The MDR increases medical device safety but also approval times and costs. Despite challenges, it's promoting higher industry standards and adaptability.…
Pharmaceutical packaging, both primary and secondary, plays a vital role in maintaining drug safety, promoting proper usage, and improving health outcomes. It's a critical, yet often overlooked, aspect of healthcare delivery.…
ChatGPT can streamline the creation of audit checklists for quality management standards such as ISO 9001 or ISO 13485. This article showcases how to leverage ChatGPT to transform standards requirements into audit questions, saving time and resources.…
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