4 Key Parts to a Complete Product Complaint Handling Program
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...
What is Blood Plasma?
Blood Plasma, or simply plasma, is the liquid portion of blood. It has a number of vital functions in bleeding and infection control. It contains proteins and antibodies, which are produced by the...
Which Comes First, People or Systems? - Building & Maintaining Regulatory Compliance
Regulations require the pharmaceutical industry to be compliant, have and maintain a quality system, and build quality into the process (quality by design). What does that truly mean and how does the...
The Use of a Target Product Profile Early in Drug Development - A Great Program Management Tool
Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a...
Project Management - 100% Responsibility and 0% Authority
Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...
Five Most Common Mistakes When Writing an Investigation
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
Do you need a starting point for a Serialization User Requirement Spec (URS)?
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...