Read, Learn, Innovate: Top Blog Posts from March 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from March 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
As we continue to monitor the COVID-19 pandemic, our thoughts are with our Members and those impacted. We recognize that the ever-changing impact of this novel virus is disruptive to so many aspects of our personal and professional lives. We are not insulated from these disruptions; but I want to assure you that ISPE is here to support your knowledge and connectivity needs.
This Blog focuses on the topic of infrastructure, covering recommendations made by an FDA / industry team linked to the FDA Case for Quality initiative, and the GAMP re-examination of approaches to infrastructure.
One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.
ISPE places the health and safety of its members, staff, and the broader ISPE global community as its top priority. As the COVID-19 outbreak continues, the ISPE Drug Shortages Initiatives Team encourages everyone to follow the available safety and health guidance applicable to your communities. Additionally, ISPE has a long-standing commitment to preventing and mitigating drug shortages.
We are constantly being influenced and we ourselves are influencers. As children, we hear the quote that “sticks and stones may break my bones, but words will never hurt me.” What people say and even what people do not say, can have a lasting impact. We are first influenced by our families and some...
2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...
Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain...