Insider Solutions

Tools of the Trade for Preventing Drug Shortages

March 02, 2015

A new technical report guides bio/pharma companies in establishing a risk-based approach for prevention and management of drug shortages.

Investigational Product Expiry Management

September 12, 2014

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses the use of interactive response technologies in investigational product expiry management.

Linking Drug Shortages and Quality Metrics

May 02, 2014

Industry players offer suggestions for quality metrics as FDA continues to try and solve the problem of drug shortages.

The Elements of Training

September 02, 2013

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

The Human Error Behind Human Error

February 02, 2013

A thorough investigation of all possible causes of deviations should be performed.

Advice for Enhancing the Client–Sponsor Relationship

November 02, 2012

Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.

Know the Regulations

April 02, 2012

The contract provider needs to know as much as the NDA holder.

Auditing by the Numbers

December 02, 2011

Contract organizations must have highly organized teams and plans to accommodate today's audits.

Following our Own Instructions

June 02, 2011

Why SOPs are rarely followed, often cited, and in need of follow-through.

Insider Solutions: Reporting Equipment Changes

March 02, 2011

What to do when your CMO changes the manufacturing equipment line.