April 20, 2021
By Jean Boudaud, Device Consulting Manager and Senior Consultant, Brandwood CKC, and Brandwood CKC
As of the February 25, 2021, the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002 relating to the regulation of personalized medical devices was enacted. Understand the most notable changes.
April 15, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Regulators began increasing focus on data accuracy long before the pandemic, but it’s a trend that’s only continuing to gain more momentum. Discover how data connectivity improvements are helping pharma companies align with regulatory dynamics and get drug products to market faster.
April 9, 2021
By Nancie E. Celini, DrPH, Organizational Change Management Leader, Think-OCM.org
To meet GxP training requirements, it’s important to understand the basics: what GxP means, how it relates to regulatory compliance, and how organizational change management can help you ensure your team receives adequate and consistent training.
Sequence Senior Consultant Peter McGrath weighs in on the struggles of traditional computer system validation (CSV), and how they can be solved with a risk-based approach. Months of time are spent on traditional CSV to the process, which produces piles of documentation. It doesn't have to be that way.
April 6, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.
April 1, 2021
By David Butcher, Staff Writer, MasterControl
In 2020, the COVID-19 pandemic brought to light the importance and acceleration of digitization. As precision medicine organizations continue reviewing and adjusting processes beyond the COVID-19 pandemic, there are some practical applications to consider in their efforts to embrace a modern approach to technology.
March 30, 2021
By Dale Thompson, Staff Writer, MasterControl
In the growing field of personalized medicine, there are significant opportunities for contract manufacturers, and the challenge to keep up with demand can be met by adopting the right technology.
March 24, 2021
By David Butcher, Staff Writer, MasterControl
Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.
March 22, 2021
By David Jensen, Staff Writer, MasterControl
Artificial intelligence (AI) technology has become pivotal in mainstream health care. The influx of big tech firms collaborating with incumbent life sciences companies to develop AI-based medical devices indicates that this trend will continue at a rapid pace.
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.
