January 23, 2019
By Sarah Beale, Staff Writer, MasterControl
When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.
December 20, 2018
By Beth Pedersen, Staff Writer, MasterControl
5S, the system of workplace standardization and organization which originated in Japan, has helped countless manufacturers reduce waste and optimize efficiency. Now, a sixth “S” is turning this lean initiative into a centerpiece of corporate culture, making it more about people than profit.
November 15, 2018
By Joy McElroy, Consultant and Business Development Director, Maynard Consulting Company
Consumers and patients assume manufactured pharmaceuticals are safe and effective. In order for quality units to assure this, you have to have a robust quality control (QC) and quality assurance (QA) program guided by an equally sound quality management system (QMS). Learn the roles of QC and QA and how to create a QMS that will help your company maintain a high level of quality.
October 11, 2018
By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)
Failure modes and effects analysis (FMEA) is a particularly effective tool in risk management. But its use is often accompanied by fear or pain because practitioners struggle to apply it. Learn how to effectively use FMEA without trepidation to improve your company’s risk management operations.
October 4, 2018
By Sarah Beale, Staff Writer, MasterControl
The nutraceutical world is constantly evolving to meet consumer needs and the search for alternative delivery forms is a prime example of this. To combat pill fatigue, supplements now come in liquids, powders, lotions and sprays, but companies embracing innovation need to be aware of the challenges they face.
August 2, 2018
By Sarah Beale, Staff Writer, MasterControl
Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.
July 12, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers.
Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.
June 14, 2018
By Jonathan M. Lewis, Prinicipal, Advanced Biomedical Consulting
A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.
May 31, 2018
By Philippe Charbon, President, Apsalys
An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.
May 29, 2018
By Philippe Charbon, President, Apsalys
The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.
May 1, 2018
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
January 18, 2018
By Sarah Beale, Staff Writer, MasterControl
For nutraceutical companies, recent headlines promising an FDA crackdown on homeopathic products were probably a bit unsettling. Traditionally the FDA hasn't been involved with homeopathy, but this new guidance means that companies will have to become compliant with these six risk-based categories.
October 24, 2017
By Wolfgang Schmitt, Vice President, Concept Heidelberg
Both the European Compliance Academy (ECA) and the European Qualified Person association (EQPA) are often contacted by people who would like to become a Qualified Person (QP according the EU Directives) outside of the EU. Is this possible?
