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Henry Macartney

Dr. Macartney began his career within the medical device and pharmaceutical fields where he was involved in research and development before moving to the central computer division of the company’s research division located in Upper Bavaria, Germany. In 1996 he started his career in the consulting industry. An industry-wide recognized expert who has issued various publications supporting industry standards, Dr. Macartney is also referenced by the National Academy of Sciences.

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 Response[...] Read More

Getting to Know FDA Software Validation Principles

October 3rd, 2014 by

FDA Software Validation[...] Read More

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the [...] Read More

How Can Your Firm Implement QSIT Principles?

August 25th, 2014 by
QSIT Principles

Are You Using QSIT [...] Read More

How Can Your Firm Use Quality Risk Management?

July 25th, 2014 by

Quality Risk Management[...] Read More

What Makes a Quality Management System Effective?

July 11th, 2014 by

Quality Management SystemModern quality management systems are often called upon to help their users meet varied regulatory standards and guidelines. For instance, your company may employ a single [...] Read More

Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by

FDA Warning LettersMost life-sciences firms would agree that the best way to prepare for FDA [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex [...] Read More

Quality Management Steps of Risk Assessment

May 22nd, 2014 by

CAPA Risk ManagementQuality risk management implementation identifies and manages risks; under normal circumstances the [...] Read More

Are You Up To Speed On The FDA’s New Regulation On Supply Chain Integrity

May 16th, 2014 by

FDA Supply Chain IntegrityThe Division of the Supply Chain Integrity of the FDA has two main goals, which are:

  1. Reducing the likelihood that unsafe, ineffective, and poor quality drugs will enter the supply chain and reach consumers.
  2. Raising public awareness [...] Read More