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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

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

FDA Official Tells Industry How To Avoid Excipient Trip-Ups When Filing ANDAs

FDA official tells generics firms how to avoid letting excipient filing mistakes prompt ANDA derailments via refuse-to-receive letters.

United States Compliance

FDA Sheds Light On How It Will Gauge Pharmaceutical Quality During Inspections

The US FDA announces plans to expand its new protocol-based approach to inspections, NIPP, to non-sterile drugs and provides glimpse of what metrics the agency is using to measure pharmaceutical quality during inspections.

Manufacturing Quality
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