March 19, 2021
By Michelle Sceppa, Principal, MSceppa Consulting
Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions, including drugs, biologics, devices, and therapy protocols. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety. Good Clinical Practices (GCPs) provide a platform for the quality of the data and a unified standard for the conduct of clinical trials. Understand the most common issues cited in U.S. Food and Drug Administration (FDA) inspections of clinical trials, and know how to avoid them.
March 18, 2021
By Dirk Stynen, Ph. D., President and Principal Consultant, Qarad BV
Electronic distribution of instructions for use (eIFU) are becoming widely used among medical device manufacturers. Due to the increasing popularity, it is critical to understand eIFU within the context of regulations, particularly Europe’s new medical device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
March 16, 2021
By Jon Beckstrand, CEO, MasterControl
We have built technology for life sciences quality and manufacturing for more than 25 years and I have been involved in that effort for 19 years. It wasn’t until 2014 that we realized the why behind what we do and it wasn’t until 2020 that our mission became crystal clear to everyone on our teams.
March 12, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
To actualize quality, you first must define the concept and clarify its objectives. Explore the relationships between the various functions that contribute to the overall quality management system (QMS) and learn about the critical role digital tools play in helping companies meet their quality goals.
March 11, 2021
By José Mora, Owner, Atzari Enterprises, L.L.C.
Controlled documents tend to be weighed down with unnecessary information. When lean principles are applied to documentation practices, it becomes evident that most documents can be trimmed down to a comprehensive and useful level while maintaining compliance.
March 10, 2021
By Regulatory Compliance Associates Inc., and Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc.
The deadline for the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) is about a year away, and if you haven’t started preparing, now is the time. Understand the challenges you might face during the process and what you can do to address them.
March 5, 2021
By Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative
In 2009, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched an initiative to harmonize regulatory supervision of clinical trials. It streamlines collaboration and information sharing between the two regulatory bodies on good clinical practice (GCP) inspections. Quality and compliance expert Maria Dorat gives an update on the initiative and explains how harmonization is working during COVID-19.
March 4, 2021
By Dale Thompson, Staff Writer, MasterControl
If manufacturers want to move business away from China, or elsewhere, there are important considerations to take into account. Cynthia Kalina-Kaminsky, Ph.D. and owner and consultant for Process & Strategy Solutions, working with Quality Support Group, explains more in this Q&A.
March 3, 2021
By Sarah Beale, Staff Writer, MasterControl
The start of the new year was a sign of hope, more so than any other year in recent history. However, even as we wait for things to get better, nutraceutical companies are facing severe supply chain problems due to increases in demand and transportation problems brought on by the pandemic.
Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.
February 25, 2021
By Regina Fullin, Vice President of RA/QA Consulting, Compliance Team
Five of the most common compliance problems and how to avoid them including documentation issues, lack of quality oversight, neglecting to assess risks, not learning from mistakes, and failure to follow through on commitments.
February 22, 2021
By Managing Director, Qualitech Engineering and Compliance
AI is moving quickly, and before long, it will play an integral role in the pharmaceutical sector. The benefits of AI include improving efficiency, streamlining production, and shortening the length of time it takes to conduct quality reviews. The result is getting product to market faster.
February 17, 2021
By Sarah Beale, Staff Writer, MasterControl
The new year might turn out to be just as unpredictable as the old. But, there’s one thing that we at MasterControl have full confidence in: Quality data will become more accessible and provide more insights than ever before.
February 15, 2021
By Christine Park, Founder and Consultant, Christine Park & Associates
The FDA has increased focus on the effectiveness of failure investigations during inspections in recent years. A review of 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to truly identify root cause.
February 12, 2021
By Rod Farrar Director, Paladin Risk Management Services
The task of measuring the benefits risk management brings to an organization is a challenging one. To overcome this challenge, the measurement of risk management performance needs to consider a wide range of factors.
February 10, 2021
By Dale Thompson, Staff Writer, MasterControl
The president of Wellington Foods, a leading contract manufacturer of nutraceuticals, explains why quality should be an organization’s top priority. This approach helps manufacturers achieve better process control and plan for significant growth without worrying about highly complex manufacturing processes.
February 9, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Think only big pharma companies with deep pockets can benefit from artificial intelligence and other advanced technologies? Think again. AI is the future of pharma, and nowadays companies of all sizes are starting leverage it to streamline quality processes. Learn the pragmatic steps you can take today to position your company to get good returns on AI investments.
February 4, 2021
By David Jensen, Staff Writer, MasterControl
An Investigational Device Exemption (IDE) is a regulatory option that allows an investigational medical device to be used in a clinical study in order to collect safety and effectiveness data. This article explains why medical device manufacturers would seek an IDE and how they apply for the designation.
February 2, 2021
By David Jensen, Staff Writer, MasterControl
Life sciences companies have long generated vast amounts of data as a byproduct of their processes for developing and manufacturing products. Quality is one area of the business that is particularly dependent on data. This article explains how companies are emerging as leaders in their industries by implementing a data-driven approach to quality management.
January 28, 2021
By Vice President, Navigator Business Solutions
Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.
