Read, Learn, Innovate: Top Blog Posts from August 2020
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from August 2020. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
Data Integrity & Its Criticality in Quality Systems & Data Automation
Data provides direct evidence that products are safe and effective – telling the story of drug products, long after they have been manufactured and shipped. As part of its mission to ensure the safety, efficacy and quality of products produced by the pharmaceutical industry, the FDA expects that all data submitted to the agency to obtain market approval is both reliable and accurate.
Agile Software Development in GxP Regulated Environments Special Interest Group
There is sometimes a perception that computer systems validation requires a V-Model approach using a waterfall methodology. This means all requirements must be agreed before design can progress and in turn all design must be signed off before the system can be built, and so on until system release into operation.
Quality Management Maturity Framework - ISPE Advancing Pharmaceutical Quality Team and University of St.Gallen OPEX
ISPE’s Advancing Pharmaceutical Quality (APQ) team and the University of St.Gallen Operational Excellence (OPEX) team have partnered to develop a comprehensive program for assessing and improving an organization’s Quality Management Maturity. ISPE is developing the Advancing Pharmaceutical Quality Assess, Aspire, Act and Advance Framework, a program comprised of quality maturity assessments, key performance indicators (KPIs), and continual improvement tools focused on advancing organizational capabilities across the four ICH Q10 Pharmaceutical Quality System (PQS) elements:
Best Practices for Maintaining Pharma Supply Chain Continuity in a Complex & Dynamic Environment
Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive forum providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders.
How to Maintain Pharma Supply Chain Reliance, Overall Quality, & Compliance Sustainability
Making clinical trials more patient centric is among the many challenges facing the pharmaceutical industry. One method of improving the patient experience is by delivering study medication directly to patient homes, also known as Direct-to-Patient or DtP. However, the implementation of Direct-to-Patient may seem insurmountable in a highly regulated industry where specific regulations or guidance is lacking or vague.
