Read, Learn, Innovate: Top Blog Posts from May 2021
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Foundations of Quality Risk Management as Fundamental for Digitalization
While Pharmaceutical development and manufacturing have focused for years on robust quality management systems (QMS), the application of quality risk management (QRM) applying digital tools and advances are critical to future success. Coupling controls, artificial intelligence, and associated platforms with basic QMS and QRM affords a great opportunity for the pharmaceutical industry.
Impact of Comprehensive Responses to Regulatory Actions on Sustainable Manufacturing Quality
Quality is the strongest force multiplier for any organization’s growth. Attaining higher quality levels has a multi-dimensional effect throughout any organization. Creating and sustaining a passion for quality brings higher levels of responsiveness, confidence and flexibility to organization wide manufacturing operations.
Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) across the Product Lifecycle
Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture
COVID Alliance - How the ISPE Helped Ireland Respond to COVID 19
Early in March 2020, many around the world viewed the sight of collapsing intensive care units in Northern Italy, overwhelmed by COVID19, with great anxiety and we wondered how we might address the inevitable arrival of the virus at our doorsteps.
Business continuity planning for drug shortages prevention
ISPE is pleased to announce that its Drug Shortages Initiative Task Team is launching a new phase of work to focus on business continuity planning for the prevention of drug shortages. We invite your company to participate. The first activity is a benchmarking study that will launch in May 2021 and be used to assess best practices and industry accomplishments in the area of business continuity planning to prevent drug shortages.
