June 28, 2018
By David Jensen, Staff Writer, MasterControl
Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.
June 26, 2018
By Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting
If you're getting close to submitting a medical device for market clearance through the FDA, you may want to read this month's Regulatory Manager Tip. The best type of communication for this process is to create even greater transparency by creating a venue for interaction with FDA staff for a ""pre-sub"" review of your device submission.
June 21, 2018
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.
June 20, 2018
By James Jardine, GxP Lifeline Editor, MasterControl
Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.
June 19, 2018
By Matthew M. Lowe, Chief Product & Marketing Officer, MasterControl
In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.
June 14, 2018
By Sarah Beale, Staff Writer, MasterControl
Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.
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.
June 12, 2018
By Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting
Quality assurance professionals are experts when it comes to talking about time management. But how to they fare in practice? Find out in this month's Quality Manager Tip by Walt Murray.
June 7, 2018
By Grant Bennett, CEO, Brandwood Biomedical
If you’re considering the Australian market for your medical device product and don’t have CE marking, the conformity assessment is an ever-increasing opportunity to enter the market. Furthermore, with the ever-changing landscape in Europe, many would suggest that Australia's Therapeutic Good Administration (TGA) is a well-established and understood pathway, whereas the European market is becoming somewhat more challenging and less understood.
June 5, 2018
By Marci Crane, Staff Writer, MasterControl
Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.
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).
