August 14, 2017
By Steve Tyrell, Senior Director, Business Development, Regulatory Compliance Associates Inc. and Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.
Insights on working with regulatory bodies on novel devices such as artificial intelligence, machine learning and algorithms.
July 11, 2017
By Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.
Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.
June 15, 2017
By Susan Schniepp, Distiguished Fellow at Regulatory Compliance Associates, Inc
One of the most discussed and debated topics on today’s pharmaceutical landscape is the issue of quality metrics. Establishing, maintaining, and interpreting quality metrics to determine the suitability of pharmaceutical products has become a high priority for the FDA. To understand the issue of quality metrics it is important to start at the beginning.
June 8, 2017
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?
Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.
May 23, 2017
By Marci Crane, Staff Writer, MasterControl
It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.
April 27, 2017
By Drew Locher, President, Change Management Associates
If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the ""we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies.
For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed). In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A com
April 18, 2017
By Marci Crane, Staff Writer, MasterControl
The following article is a Q&A regarding the release of the Global Harmonization Task Force Final Document: Role of Standards in the Assessment of Medical Devices (acknowledged in this article as the RSAMD final document).1 Q: What is the Global Harmonization Task Force (GHTF)? A: The GHTF is a voluntary group that consists of trade association and medical device authorities from the USA, Canada, Europe, Japan and Australia. Q: Who is the authoring group for the RSAMD final document
April 18, 2017
Antoinette Azevedo, Founder of e-SubmissionSolutions.com
The United States Food and Drug Administration (FDA) is taking concrete steps to require the submission of all types of regulatory communication in electronic format. Globally, regulatory authorities are all moving to require electronic submission of regulatory communication. The reasons are many but one reason is clear: the public safety responsibilities of the regulators requires significantly faster access to content that can be supported by paper format.
As of June 1st, 2009 the FDA will no longer accept Establishment Registrations or Product Listings submitted on paper for human prescription drugs, human over-the-counter drugs, or listed biologics and veterinary medicines. After that date, all such filings must be made electronically through the FDA's electronic submission gateway and encoded in XML, according to the rules set out in the HL7 Structured Product Labeling (SPL) standard and the FDA implementation guide. Medical devices are not c
As regulatory agencies such as the U.S. Food and Drug Administration (FDA), and parallel agencies in Europe, Japan, and Canada, move toward a completely electronic submission environment, tools like templates for Microsoft Word® become increasingly essential to submissions content development processes. Templates can be essential during the preparation of electronic common technical documents, or eCTDs. The eCTD is a standard created by the International Conference on Harmonisation (ICH), a
April 18, 2017
By Craig Barrila, World Wide Head of Information and Records Management, Pfizer, and Beth Boucher, World Wide Head of Global Network Services, Pfizer
Like many other pharmaceutical companies, Pfizer has been through numerous mergers, acquisitions and divestitures. Two notable ones were the acquisition of Warner Lambert in 2001 and Pharmacia in 2003. The mergers, acquisitions and silo work practices fractured Pfizer's highly regulated and controlled documentation over many sites and systems. This included our GxP Standard Operating Procedures, product labeling, submissions management and trial master file systems.
April 18, 2017
By Karl Vahey, Director of Compliance, International RA/QA, Covidien
Why should medical device manufacturers perform failure investigations? One reason is that it is a regulatory requirement. The Code of Federal Regulations (21 CFR 820) in areas such as Non-Conforming Product, Corrective and Preventive Action and Complaint Files describes the requirements for failure investigations. Performing effective failure investigations is also good business practice which can lead to reduction in scrap and rework, process improvements and the elimination of recurring issue
April 17, 2017
By Denise Dion, Senior Consultant, EduQuest, Inc.
At first glance, FDA's Quality System Regulations (QSR) for medical devices - contained in 21 CFR 820 - may make your eyes cross and your stomach churn. The rules are intimidating, yes - but impossible to follow, no.
Pharmaceutical companies that promote their products for off-label use continue to be the subject of intense regulatory scrutiny. But they are no longer alone. Recent statements by government prosecutors suggest an increased focus on the sales and marketing practices of device companies. The medical device industry should expect heightened scrutiny from the "usual" actors, including the Food and Drug Administration (FDA), the Office of the Inspector General (OIG) of the Department of Health and
April 17, 2017
By Dan O'Leary, President, Ombu Enterprises
Process validation is an essential part of medical device manufacturing but doesn't always receive the attention it deserves (and requires). The regulations provide the requirements (FDA QSR 820.75 and ISO 13485 7.5.2), but often manufacturers don't completely understand them and don't fully implement them. The consequences can be audit findings from a Notified Body or Inspectional Observations on an FDA 483.
With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.
