February 6, 2018
By Craig Morgan, Head of Marketing, goBalto
A recent analysis by the Manhattan Institute determined that Phase III clinical trials account for 90% or more of the cost of developing an approved drug from laboratory to pharmacy. [1] Given that reliable estimates put the cost of developing, and gaining marketing approval for a new drug, at well over a billion dollars,[2] it’s clear that human trials are pivotal to the pharmaceutical industry scrambling to find ways to reduce costs and speed timelines, while maintaining the quality and efficacy of the research.
February 1, 2018
By Luana Carone, Solutions Consultant, Asia Pacific, MasterControl
It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.
January 30, 2018
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
A good place to start is to identify the key stakeholders and decision makers in each department. This exercise will show you how close what is on paper is aligned to what is done in practice. Finding out “who is who” in each department will come with an explanation of their activities… pay attention to the overall scheme and coordination that takes and the various approaches, tactics, and means each department uses to accomplish their tasks. You will need this understanding to be effective as a regulatory leader.
January 25, 2018
By Philippe Charbon, President, Apsalys
Since the U.K.’s Medical and Healthcare product Regulatory Agency (MHRA) (1) and the U.S.’s Food and Drug Administration (FDA) (2), published on this subject in 2015 and 2016, respectively, data integrity continues to gain importance as an issue. Some workshop participants wondered if this is simply a new trending topic that will quickly fade. I firmly believe that it is not.
January 23, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.
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.
January 16, 2018
By Michelle Lott, Principal and Founder, Lean RAQA
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Practical Guide defines “risk-based approach,” varying terminology, and which systems require it.
January 11, 2018
By Mary Lewis, Senior Clinical Research Specialist, IMARC
Manufacturers have used a quality systems approach to ensure consistency within their processes for years, but the FDA is now encouraging clinical researchers to take a similar approach to medical device trials.
January 9, 2018
By David Butcher, Staff Writer, MasterControl
Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.
January 4, 2018
By Mike Rigert, Staff Writer, MasterControl
A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD). The guidance means to address the emergence of thousands of stand-alone, health-oriented software apps that fall into a gray area in terms of regulation. Obviously, SaMDs aren’t traditional medical devices, but neither are they Pokémon Go.
December 19, 2017
By Marci Crane, Staff Writer, MasterControl
Before Santa can fill the stockings of good children from across the world, he and his elves must be inspected and/or audited by certified auditing bodies and similar organizations from around the world. Why? Because Santa must prove that the sweet treats he manufactures measure up to high quality standards for all children everywhere.
December 7, 2017
By Betsy Fallen, BAFallen Consulting LLC
Just about everyone in the drug development industry has cited 21 CFR Part 11 at one time or another. Fondly referred to as “Part 11,” the August 1997 regulation was last referenced by the FDA in 2003 with the release of a Guidance for Industry - Part 11, Electronic Records; Electronic Signatures — Scope and Application.1 Since then, the centralized research team has significantly changed from only a few stakeholders into a system of many globally distributed contributors. The industry’s documentation has transitioned from paper files to dynamic, integrated systems supporting digital records spanning the bedside to the research clinic. The delivery of healthcare has evolved from the confines of brick and mortar to cloud-based platforms that could only be dreamed of a few years ago.
According to a recent AberdeenGroup report, life science companies face pressures that "typical" manufacturers do not. These pressures include "complying with government regulation and providing traceability in their operations." Because of these pressures, life science companies often stand at a mediocre level in terms of first pass yields, overall yields, and DPMOs (defects per million opportunities).
December 5, 2017
By Michelle Lott, Principal and Founder, Lean RAQA
Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2016, hoping September’s release of the "ISO 13485:2016 – A Practical Guide" (hereafter known as the “Practical Guide” or “Guide”) would bring the “practical” guidance promised.
October 31, 2017
By Craig Morgan, Head of Marketing, goBalto
For clinical research, Study Startup (SSU) is the pivotal period that lays the groundwork for a successful study. By ensuring that the right sites are selected and target subjects are recruited in a timely and cost-effective manner, mission critical risks can be avoided that lead to runaway costs and delays.
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?
October 17, 2017
By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners
Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?
September 21, 2017
By Laurie Meehan, Social Media Manager, Polaris Compliance Consultants
You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.
September 10, 2017
By Dave Richardson, Senior Analyst, Cutting Edge Information
It's no secret that pharmaceutical companies have great concerns about their overall compliance efforts. In fact, in several conversations that I've had with executives from marketing, sales, clinical, medical and other functions, it's rare to hear that compliance isn't a hot-button issue.
