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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”
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Latest From Joanne S. Eglovitch

Risk-Based Approach To Protecting Data Integrity Outlined In Forthcoming PDA Report

An upcoming PDA technical report is expected to build on the concepts of an earlier report on laboratory systems and propose a risk-based approach for protecting data integrity using a nine-box grid for assessing data integrity risks.

Manufacturing Quality

FDA Warns Glenmark Over Temperature Excursions, Gritty Topicals

Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.

United States Manufacturing

PDA, ISPE Launch Quality Culture Effort With Root Cause Analysis Guide

Industry groups PDA and ISPE have banded together to produce a guide to help pharmaceutical manufacturers get a better handle on their deviations through choosing the right root cause analysis method and human factors studies.

United States Manufacturing

Some Pointers From The US FDA On How To Conduct Better Out-Of-Spec Investigations

Industry is still having major problems in this area despite the FDA's exhaustive 2006 OOS guidance.

 

Manufacturing Quality

EU Guide Aims To Help Manufacturers Avoid Setting Off 'False Alarms' Under FMD

To reduce false alarms of counterfeits, EU tells drugmakers no lowercase, hyphens, question marks or certain letters in serial and batch numbers.

Europe Manufacturing

US FDA Warns Lupin Again About Poor Batch Failure Investigations

Agency demands review of invalidated out-of-specification findings as root causes of failures continue to elude Indian drugmaker at multiple facilities.

Manufacturing Quality
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