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 24, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.
May 22, 2018
By Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health
Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.
May 15, 2018
By Terry Walsh, Director APAC, MasterControl
The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.
May 3, 2018
By Rod Farrar Director, Paladin Risk Management Services
With risk management, governments and companies often rely on having a fraud control plan. But typically, a risk register is more effective at detecting, responding to and preventing various types of organizational fraud.
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.
It has been proven time and again that necessity is the mother of invention. From the printing press to electric cars, the story is similar. The printing press answered the need for a more rapid dissemination of information during the Renaissance, while the electric car is a response to the need for a zero-emission car today. In regulated environments, the dire need to lighten the software validation burden led to the development of a groundbreaking application.
April 24, 2018
By Hedley Rees, Managing Consultant, PharmaFlow
Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.
April 19, 2018
By Mark Schwartz, Director, Hyman, Phelps & McNamara
Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).
April 17, 2018
By Mike Rigert, Staff Writer, MasterControl
Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.
April 12, 2018
By David Jensen, Staff Writer, MasterControl
At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.
April 5, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This month's tip concerns complaint analysis, and the fact that much of the labor of collecting the information for this quality step has already been recorded in writing during the pre-market phase by quality personnel.
April 3, 2018
By David Jensen, Staff Writer, MasterControl
First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).
March 29, 2018
By Craig Morgan, Head of Marketing, goBalto
A look at how the changing makeup of the clinical research workforce, with particular attention to the millenial generation, may present future adjustments and opportunities.
March 20, 2018
By Mike Rigert, Staff Writer, MasterControl
The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.
March 15, 2018
By David Jensen, Staff Writer, MasterControl
I recently attended the 2018 MD&M West conference, Feb. 5 – 7, in Anaheim, California. The three-day event pulled together the medical device industry’s top engineering, design and regulatory compliance experts. This year’s conference covered the most timely and pressing topics, including technology, cybersecurity, design control, digital health and regulatory updates.
When the medical device excise tax was suspended recently, the industry was left with a sense of déjà vu. Between January 2013 and January 2018, the tax was implemented once and frozen twice. How long will this touch-and-go situation continue?
March 8, 2018
By Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines
It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.
March 8, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
This is the third post in the series, “The Practical Guide to the ISO 13485:2016 Practical Guide” for medical devices. This post explores examples and application provided within Practical Guide for the implementation of a “risk-based approach.”
