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.
The pharmaceutical industry’s work on developing treatments and vaccines for COVID-19 (novel coronavirus) is moving forward, including these recent developments:
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.
ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE Regional Affiliate Councils collaborate efficiently with the international ISPE organization and local regional peers to ensure optimal alignment and support for local success. ISPE currently has three regional affiliate councils including: Asia-Pacific Affiliate Council (APAC), European...
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset Condition Evaluations and Asset Management Governance. CSL was keen to continue the conversations and gather more insights on certain...
At the 2024 ISPE Annual Meeting & Expo, in Orlando, Florida, this past October, ISPE proudly recognized Niranjan Kulkarni, PhD, with the prestigious Max Seales Yonker Award, as part of the 2024 International Honor Awards. Kulkarni was honored for his extraordinary volunteer service, leadership, and unwavering commitment to...