• The Data Driven Reality of Clinical Trials

    7 March, 2017 by Craig Morgan, Head of Marketing, goBalto

    Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

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  • 2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

    2 March, 2017 Marci Crane, Staff Writer, MasterControl

    For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of

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  • Supplier Approval Challenges Under FSMA

    1 March, 2017 Erika Miller, Food Safety Specialist, D.L. Newslow & Associates, Inc.

    As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Prog

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  • The Migraine Known as the Supplier Audit — and Some Simple Remedies

    23 February, 2017 Ken Christie, COO, VTS Consultants

    The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However

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  • Quality Pros & the Oscars: Films to See Based on Your Personality

    16 February, 2017 Cindy Fazzi, Staff Writer, MasterControl

    It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

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  • Recognizing the True Heroes of Life Science on Donor Day

    13 February, 2017 James Jardine, Staff Writer, MasterControl

    ) estimates that an average of 22 people die every day because the organs they need to survive are not donated in time to save their lives. Five years ago, I was within days of becoming one of those death statistics. But the heroic actions of someone I will never know ensured that my two sons still have a father. While some may only turn their thoughts to organ donors every February 14

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  • Avoiding the CAPA Calamity

    9 February, 2017 Ken Peterson, Director Quality Services, MasterControl, Inc.

    Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all tha

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  • How to Lead with Respect

    7 February, 2017 Mike Orzen, Founder, Mike Orzen & Associates

    “Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”

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  • Supplier Qualification: An Important - and Often Neglected - Validation Component

    2 February, 2017 by Robin Nozick, Business Development Consultant, BC Solutions, LLC

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    2 February, 2017 by Lisa Weeks, Staff Writer, MasterControl

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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  • 12 Free Resources to Supercharge Your Supplier Management System

    31 January, 2017 James Jardine

    To get what they truly want, businesses—just like people—often must rely on outside help. Even the most adept companies with the best ideas need to rely on external collaborators at some point if they want to achieve their aspirations and accomplish big tasks. Partnering and outsourcing are compulsory, mutually beneficial practices in today’s dynamic business environment.

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  • 5 Reasons Why Leslie Knope Should Manage Your SOPs

    24 January, 2017 David Jensen, Marketing Communications

    Compliance observations and warning letters regarding standard operating procedures (SOPs)—or the lack of—in life sciences manufacturing facilities are as common as fruitcake during the holidays. How can medical device and pharmaceutical manufacturers hope to reduce the exorbitant number of documentation infractions? Get Leslie Knope to manage your SOPs.

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  • Surviving Live Data Inspections by the FDA---3 Critical Success Factors

    19 January, 2017 B. Christine Park, CQA, CQM/OE Consultant

    I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection. Historically, you’d print the files for FDA review rather than do a live demonstration of the database information. While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review. Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.

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  • 5 Tips for Bolstering Cybersecurity

    12 January, 2017 David Jensen, Marketing Communications, MasterControl

    Cybersecurity can be exhausting and difficult to control—even for IT pros. A security risk management executive at AbbVie Inc., discussed cybersecurity at the 2016 PDA/FDA Joint Regulatory Conference and offered some tips for how you can ramp up your organization’s IT security efforts.

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  • 5 Things I Learned about FDA Audits from its Sister in Compliance, the FCC

    10 January, 2017 Anthony Rossi, Sales Operations Specialist, MasterControl

    Before I came to work at MasterControl, I was an operations coordinator at a company called CaptionCall. CaptionCall provided telephone captioning to the hard of hearing, and because it was funded through federal taxes we were directly overseen by the FCC. While I was working at CaptionCall, I was directly involved in an audit performed by the FCC. The day of the inspection was one of the most stressful days in my career.

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  • 5 CAPA Best Practices You Should Be Doing Now

    5 January, 2017 Cindy Fazzi, Staff Writer

    Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.

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  • Protect Your Investments!

    29 December, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International

    Did you miss old doctor? Dr. D is back from a two-week hiatus that included some drinkin’ and thinkin’, and is again ready to continue with the dispensing of guidance for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements has always been one Dr. D’s salient goals, along with providing a few chuckles. Besides, the

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  • 5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

    27 December, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.

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  • Love it or Hate it, the 21st Century Cures Act is a Big Step Forward

    21 December, 2016 Cindy Fazzi, Staff Writer

    The 21st Century Cures Act is a massive piece of legislation (996 pages) with an equally tremendous ambition. The life science industry heralded it as a victory, while critics expressed some concerns. Everyone agrees, however, that there’s a need to support medical innovation and advance regulatory compliance. The reform-minded law unites all sides to that extent.

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  • Santa Claus Is REAL but He Requires an EQMS!

    20 December, 2016 Marci Crane

    Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

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