• How Will the FDA's New Clinical Investigations Guidance Affect Pharmaceutical Companies?

    18 April, 2017 MasterControl

    Discusses how the FDA?s new clinical investigations guidance will positively affect pharmaceutical companies in light of recent news on the relationship between FDA and the industry

    Full story
  • Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

    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
  • 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
  • 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
  • "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
  • 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
  • FDA Compliance Software

    18 April, 2017 MasterControl

    Companies competing within the rigorous FDA regulated environments know how important attaining and sustaining compliance is to yearly success which can be easily achieved through MasterControl's FDA compliance software. MasterControl Inc. is a leading provider of FDA compliance software, helping hundreds of life science companies around the world realizes their EU regulatory and FDA compliance goals. Our quality management system meets all FDA 21 CFR Part 11 regulations.

    Full story
  • Writing and Maintaining SOPs - Sep 09 - B&B Article

    18 April, 2017 MasterControl

    "SOPs! We don't need no stinking SOPs!"

    Full story
  • AUG Writing and Maintaining SOPs: Drudgery or Delight?

    18 April, 2017 Katy McMullin, Senior Professional Services Consultant at MasterControl

    "SOPs! We don't need no stinking SOPs!"

    Full story
  • Failure Investigation: Treating the Root Cause, Not the Symptoms

    18 April, 2017 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

    Full story
  • How They Did It: Pfizer's Transition from 50 Document Management Systems to One

    18 April, 2017 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.

    Full story
  • GCP Compliance Strategies for 2009 - Medical Device Industry

    18 April, 2017 Carl Anderson, Regulatory Affairs and Quality Assurance Consultant, Field of FDA Health Product Approvals including Medical Devices, Drugs and Biologics

    The FDA press release dated April 30, 2008 should have caught the eye of every regulatory affairs and quality assurance professional responsible for compliance to the FDA. "FDA Embarks on Major Hiring Initiative for its Public Health Mission" the press release blared. "Agency will fill more than 1,300 positions within the next several months," it continued. That is more than triple the number of positions the agency filled in fiscal years 2005-20071.

    Full story
  • Beyond the Basics - Building Business Value through an Effective Compliance Program

    18 April, 2017 Peter Claude, Pharmaceuticals and Life Sciences Partner, and Jean Sands, Pharmaceuticals and Life Sciences Manager, PricewaterhouseCoopers LLP

    Through the recent overhaul of the AdvaMed Code of Ethics, medical device companies gained the opportunity to use the renewed emphasis on ethics to revamp their approach to compliance. Most companies quickly integrated the updated Code provisions into their compliance policies and trained their employees to follow explicit guidelines about appropriate and inappropriate interactions and arrangements with healthcare professionals. Now they stand ready to take the next steps to build global complia

    Full story
  • Human Factors: Why it is Critical in Designing Medical Devices

    18 April, 2017 David Jensen, Staff Writer, MasterControl

    “Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 

    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
  • 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
  • '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
  • 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