Operational Excellence in Global Clinical Research: Why Culture Drives Performance
Choosing a CRO Partner: Signals That Matter Most
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,...
Clinical Research Solutions
Stakeholder Review: Gate Two in The Nine Gate Transfer Process for Moving Production
In this, the second entry in the series, I will review Gate 2 of the Nine Gate Transfer Process utilized by ProPharma Group for successful technical transfers. Refer to my first entry for further...
Regulatory Sciences
FDA Proposes Controversial Rule Allowing ANDA Applicants to Change Drug Labels
On Nov. 13, 2013, the Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register. The title of the Proposed Rule is “Supplemental Applications Proposing Labeling Changes for...
Quality & Compliance
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...
Clinical Research Solutions
The Nine Gate Transfer Process for Moving Production from Site to Site: Gate 1
Pharmaceutical news today featured another article about a manufacturing plant closure and the layoff of a thousand employees. Demand for pharmaceutical products continues to grow and will continue...
Quality & Compliance
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...
Quality & Compliance
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...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Quality & Compliance
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...
Quality & Compliance
Lean CSV – How to Reduce Waste and Increase Value
What is lean? Lean is a business system focused on continuously improving processes by reducing the time taken and the waste involved in delivering increasing value to the customer. Customers in this...
Quality & Compliance
Risk-Based Computer System Validation and Rational Testing
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 overkill in the...
Quality & Compliance
Understanding Statistical Intervals Part 1 - Confidence Intervals
Statistical intervals are staples of the quality and validation practitioner’s statistical tool box. Statistical intervals can manifest as plus-or-minus limits on test data, represent a margin of...
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...
