Evaluating the Effectiveness of a Corporate Compliance Program: How Does Your Program Measure Up?
At the recent Pharmaceutical Compliance Congress (PCC), Zane Memeger, U.S. Attorney for the Eastern District of Pennsylvania stated that one of the key questions that a company should ask about its...
Computer System Validation: Resolutions for the New Year
How are you doing with those New Years’ resolutions? Whether or not you’re a resolution maker (or breaker), you can use this time of year to take stock of where things stand, including your validated...
Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements
A while back I was involved in a Quality Assurance project reviewing calibration specifications for analytical instrumentation. The client had implemented a new requirement that all calibrated...
Clinical Research Solutions
U.S. Attorneys Send Strong Message that a Company’s Response to a Compliance Issue is Key Element of an Effective Compliance Program
A common theme among the government enforcers speaking at last week’s Pharmaceutical Compliance Congress (PCC) was the importance of putting in place an effective corporate compliance program to...
What is the Future for Pharmaceutical Compounding Companies?
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...
Critical Elements of Knowledge Management in a Pharmaceutical Quality System
The concepts detailed in ICH Q10, Pharmaceutical Quality Systems (PQS) are commonly understood and are progressively being employed in modern quality management systems. The intent of the PQS...
Why Measure and Report Quality Metrics?
A wise man recently told me that “honor and respect should be given freely, but trust is earned”. Whether it’s in politics, friendships, church, marriages, parenting or even the business world,...
OIG Signals Importance of Board-Level Compliance Committee in J&J Corporate Integrity Agreement
In the just issued Johnson & Johnson Corporate Integrity Agreement (CIA), the Office of Inspector General (OIG) has, for the second time in less than a year, required that a company maintain a...
Government Aims its Sights on Smaller Pharmaceutical Companies
Big pharma and their deep pockets have been the focus of enforcement activities for a number of years but in 2013 that tide may be turning. In the past few months, settlements with ISTA...
Do Not Neglect GMP in your Serialization Project
In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the...
Three Solutions to Typical Autoclave Temperature Mapping Conundrums
Temperature Mapping is an intrinsic part of equipment validation. It evaluates the quality and compliant nature of the equipment to ensure the equipment meets the user and regulatory agency’s...
Personalized Medicine – How Will the Batch Size Change Our Lives?
Hardly a week goes by without the announcement of a new scientific break-through in science and medicine that promises safer, more efficacious and personalized medicine. Where are all these...
Risk-Based Computer System Validation and Rational Testing
Introduction Risk based approaches to validation of computerized systems have been heavily promoted since the publication of GAMP 5 and ASTM E2500. Yet we continue to see examples of validation...
Life Cycle Considerations for High Quality and Regulatory Compliant Software
By way of introduction I have developed, implemented, and validated computer/information systems for longer than I care to admit … they were still using punch cards to program room-sized computers...
ISO13485: Understanding the Management Review Metrics Scorecard
As discussed in part one and part two of this series, ISO13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the...
Wondering Why You Should Evaluate the Effectiveness of Your Corporate Compliance Program?
On May 24, 2013, the Department of Justice announced that ISTA Pharmaceuticals Inc., a subsidiary of Bausch+Lomb, pled guilty to felony charges of conspiracy to introduce a misbranded drug into...