• Why the 'Band-Aids' Keep Falling Off

    18 April, 2017 Vivian Bringslimark, President HPIS Consulting, Inc.

    When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Without a lot of fuss, we resolve a messy situation and expect the cut to heal in a few days. Having a box of these adhesive strips on hand allows us to reach for them again and again. The danger in applying a Band-Aid so automatically is that we fail to stop and inspect just how deep the wound really is. Maybe it wi

    Full story
  • Navigating the FDA's New Requirements for eCTD Submissions - Pharmaceutical Industry

    18 April, 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.

    Full story
  • How to Avoid Common IND Submission Pitfalls

    12 April, 2010 Meredith Brown-Tuttle, RAC, Chairperson of the RAPS Publication Board

    An Investigational New Drug Application (IND) is like an orchestra - it brings together many players with different specialties that need to work together in harmony to create a synchronous melody (in the case of the orchestra) or message about the compound (in the case of an IND). With one instrument out of tune or with one musician who does not play his or her part there will most certainly be a displeasing sound to the ear and a composition that is thrown off. The same can be said for a secti

    Full story
  • Analytical Method Validation: What is Expected?

    17 April, 2017 Michele Piepoli

    The Food and Drug Administration (FDA), International Organization for Standardization (ISO), European and other regulatory authorities have requirements and expectations regarding the performance and documentation of an analytical method validation.

    Full story
  • An Analysis of Heparin, Accountability and Pre-emption Where Are We Now?

    18 April, 2017 Christine Humphrey, Esq., Fuerst Humphrey Ittleman

    First in a two-part series, (second part)

    Full story
  • CGMP Amendment for Finished Pharmaceuticals

    18 April, 2017 MasterControl

    In December 2007, The Food and Drug Administration (FDA) announced amendment to its current Good Manufacturing Practice regulations for finished pharmaceuticals.  They amended the regulations to modernize or toclarify some of the CGMP requirements, as well as harmonize some of theCGMP requirements with those of other foreign regulators and other FDAregulations. These amendments are also consistent with current industrypractice.

    Full story
  • Adverse Event Reports Hit Record High

    Sharon Phillips

    According to FiercePharma, the number of deaths (4,825) and serious injuries (21,000) associated with prescription drugs during the first quarter of this year was higher than it's ever been.1 These numbers represent nearly a threefold increase over the previous quarter, and a 38-percent increase over last year's quarterly average.

    Full story
  • Current Political Climate Favors Passage of Drug and Device Accountability Act of 2009

    Sharon Phillips, Marketing Communication Specialist, MasterControl, Inc.

    Although essentially the same as its 2008 predecessor, the recently announced Drug and Device Accountability Act of 2009 is much more likely to become law in today's more favorable, "accountability-conscious" political climate.

    Full story
  • Medical Device Lifeline - Why Do We Have Repeat Investigations?

    Nathan Conover, Sr. Partner, Pathwise

    Repeat CAPA investigations are arguably one of the largest areas of concern for quality managers today. Despite many firms taking the recommended corrective action, repeat investigations throughout the industry have accounted for as many as 30% of all open investigations- or 1 in every 3. What's going wrong? Why is this happening to so many of us?

    Full story
  • Virtualization: Taking Advantage of Part 11 to Save Money

    18 April, 2017 John Avellanet, Managing Director, Cerulean Associates LLC

    MasterControl recently interviewed John Avellanet, the founder of the FDA regulatory intelligence and lean compliance program for executives and business owners, SmarterCompliance™, and the Managing Director of Cerulean Associates LLC. He is the author of more than 35 articles on lean compliance, Part 11, and quality systems, a contributing author to the book Best Practices in Biotechnology Business Development, and a frequent speaker with FDA officials.

    Full story
  • "Two Roads Diverged": Current Issues for the Medical Device Industry

    18 April, 2017 MasterControl

    Riegel vs. MedtronicDonna Riegel, a New York resident, has sued Medtronic, a Minneapolis based medical device maker, on the grounds that a Medtronic catheter device exploded during her husband’s angioplasty procedure and seriously damaged both his kidneys and mental capacity.  Though it was cancer that eventually claimed the life of Mr. Riegel, Donna Riegel’s attorney is suing for $5 million dollars on the grounds of inflicted injuries during the aforementioned procedure.

    Full story
  • Can Medical Device Manufacturers Speed Innovation and Lower Costs while Increasing Quality?

    18 April, 2017 Daniel R. Matlis, Founder and President of Axendia

    Medical device manufacturers have consistently focused on bringing innovative products to market. To achieve this, most companies have implemented sequential design and manufacturing processes to ensure regulatory compliance and the highest possible quality.

    Full story
  • Overcoming the Top Three Project Management Challenges

    18 April, 2017 MasterControl

    During the course of the development of a new medical device, project managers inevitably come across three major obstacles to efficient project management: regulatory constraints, resource limitations, and on-time delivery. Prevailing over these challenges may have less to do with better planning and improved project execution and more to do with the management systems employed during the product development cycle.

    Full story
  • Global Harmonization Task Force Final Document: Standards in the Assessment of Medical Devices

    18 April, 2017 Marci Crane

    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

    Full story
  • Supply Chain Oversight is the FDA's Next Area of Concern

    4 January, 2011 Alan Schwartz, Consultant, mdi Consultants, Inc., and Former Supervisor of Field Operations, USA FDA

    The FDA recently stated its intent to stretch its enforcement reach over foreign device suppliers through consent decrees. The FDA also asked manufacturers and importers to take bigger steps toward managing suppliers and tightening up the supply chain. Carmelo Rosa, an FDA compliance officer, explains that "Currently, the agency only has authority to establish import alerts for foreign companies with good manufacturing practice violations but it is looking at other options."

    Full story
  • Four Reasons Why You Should Consider Joining the FDA's STED Pilot Program

    17 April, 2017 Matthew M. Lowe

    Wouldn't it be great to launch your next product globally? It certainly makes good business sense. But for medical device manufacturers, this is an unreasonable goal because different countries and geographical regions require different regulatory submission formats. So, a 510(k) that has been cleared by the FDA is not applicable in Australia or France because of unique format requirements in those countries. What this means is that a medical device firm's schedule for product release must be ha

    Full story
  • 'Standard Work' for Problem Solving

    17 April, 2017 Chris Tsai, President of Global Productivity, Inc. and Certified Six Sigma Black Belt

    When problems occur, are they addressed in a planned, consistent, predictable way? Does a simple problem (i.e. transcription error, typo, missing part) receive the same level of rigor as a complex, multi-variate problem? Are the appropriate problem solving team resources involved and do they all have a consistent expectation of roles & responsibilities? If you're a medical device manufacturer, are investigations and the resulting documentation providing the objective evidence needed to demonst

    Full story
  • Creating and Auditing a Global Quality System

    17 April, 2017 Nancy Singer, President, Compliance-Alliance

    Medical device and drug firms with multi-national facilities have many challenges. They need to comply with numerous regulatory requirements. To increase the efficiency of their operations, many firms are creating a globally harmonized quality system for their entire organization, and they are using internal and supplier audits to maintain compliance with regulatory requirements.

    Full story
  • The Sentinel Initiative: Will it finally result in postmarket protection and premarket improvement?

    Marci Crane

    In June 2008 FDANews released an article describing CDRH's top priority which according to the article's summary is a "new postmarket initiative." Also according to the summary, postmarket issues "have taken precedence over premarket [issues]" and have garnered "the first-place slot for the center's priorities."1

    Full story