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02
Oct
A Quality Agreement Primer: Managing Risk When Working With Contractors

This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

Posted in: Manufacturing,
Tags: contractors, quality agreements, risk, subcontractors,
01
Oct
Overcoming The Challenges Of Patient-Centric Specification Setting

The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.

Posted in: Clinical, Manufacturing,
Tags: CQA, ICH, patient-centric, QbD, quality by design,
29
Sep
Capacity & Competency Of The Clinical Research Workforce — Today & Tomorrow

It’s not simply an issue of supply and demand. It’s closer to life and death. Put bluntly, we may not be able to keep up with future clinical trial demand because our workforce isn’t growing fast enough. In fact, by some metrics, we’re already falling behind.

Posted in: Clinical, Training,
Tags: clinical research, clinical trial, CRO, drug development, workforce,
25
Sep
Hazmat Regulations: What Life Sciences Companies Need To Know

It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

Posted in: Device, Manufacturing,
Tags: CFR, hazardous materials, hazmat, packaging,
24
Sep
COVID-19’s Impact On The Clinical Trial Ancillary Supplies Industry

With restrictions on logistics, and countries implementing new restrictions to address increasing COVID-19 cases, it’s important to understand how to manage clinical trials’ ancillary supplies — like sourcing from the right suppliers, managing distribution to all trial sites, stock management, and response to new regulations.

Posted in: Clinical,
Tags: COVID-19, logistics, pandemic, supplies, supply chain,
21
Sep
How To Generate The Right Input Data For An Effective Quality Management Review System

This article is the second in a two-part series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems. Part 1 discussed the importance of “top-down” quality management and “bottom-up” communication of compliance risks and concerns. Here in Part 2, we turn our attention to the input data for an effective QMR.

Posted in: Manufacturing,
Tags: CAPA, CGMP, compliance, QMR, QMS, quality,