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Showing items tagged as Regulation

  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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  • Trend Analysis: A Method for Focusing Resources

    20 February, 2018 by Mark Durivage, American Society of Quality (ASQ) Fellow and Managing Principal Consultant, Quality Systems Compliance

    Probably one of the most significant concerns for anyone responsible for implementing, deploying and maintaining a quality management system is the prioritization of resources. Trend analysis is one technique that can help determine if something has changed with a process (quality, production, or service). Trend analysis can be used to monitor a process, especially non-manufacturing processes such as complaints, nonconformances and deviations to aid in the decision for escalation for corrective and preventive action (CAPA).

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    1 February, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, 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.

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  • January Tip: Strategies for New Regulatory Managers

    30 January, 2018 by Patricia Santos-Serrao

    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.

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  • Software as a Medical Device: What Does It Mean and Why Should I Care?

    4 January, 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.

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  • Is Your Medical Device Company Headed Toward a 483?

    28 December, 2017 by Marci Crane

    Medical device companies that sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a 483 notice, which is officially referred to by the FDA as a “Notice of Inspectional Observations.” The seriousness of receiving a 483 should not be underestimated.

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  • Canada’s Evolving Regulatory Landscape

    26 September, 2017 Raleigh Malik, PhD, Sr. Scientist; DIA

    Canada’s sesquicentennial marks a period of advancement and newfound transparency, where the past has set the stage for innovators to generate novel, yet safe and effective, health care products for Canadians. From the discovery of insulin at the University of Toronto in 1921 to the development of the first HIV preventative vaccine in 2013 (which is currently undergoing Phase II trials), Canada has a rich history of drug innovation. However, with health care product innovation comes government oversight and regulations required to ensure safe and effective treatments for the public.

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  • Regulatory Strategies for AI and Emerging Technologies

    14 August, 2017 MasterControl

    Lisa L. Michels, General Counsel and Regulatory Affairs Expert, Regulatory Compliance Associates Inc.

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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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  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users

    11 June, 2015 Stacie L. Ropka and Chad A. Landmon Axinn, Veltrop & Harkrider LLP

    What does the Food and Drug Administration (FDA) consider to be “minimal manipulation” and how are human cells, tissues and tissue-based products (HCT/Ps) made from adipose tissue regulated by FDA? These questions were addressed in two draft guidances issued by FDA in late December of 2014. The first, Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations (1), focuses on how adipose tissue is defined and thus how adipose-based HCT/Ps are regulated by FDA. The second, Minimal Manipulation of Human Cells, Tissues and Tissue-Based Products (2), focuses on the types of cell and tissue processing that would be considered more than minimal manipulation, resulting in the regulation of the cell or tissue-based product as a drug, biologic or medical device. Although they are not yet final, these guidances shed light on FDA’s current thinking and may signal that FDA will make it more difficult for products to be regulated solely under Section 361. Not only will such a position by FDA impact development of new HCT/Ps, but it could threaten the regulation status of currently marketed HCT/Ps.

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  • Cosmeceuticals: the Good, the Bad and the Ugly

    19 May, 2015 MasterControl

    Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.” I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together. At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them. To get started I searched the Internet to see what others were saying about these products.

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  • What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

    28 August, 2014 Peter Knauer, Senior QCC Consultant, MasterControl Inc. and Moj Eram, Regulatory Consultant

    This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.

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  • Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers

    26 August, 2014 Les Schnoll, Quality Docs, LLC

    In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

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  • Quality’s Role in Drug Approvals

    12 June, 2014 by Theresa Allio, Ph.D.

    In a recent review, I summarized the underlying reasons contributing to delayed market entry for 51 product applications submitted to CDER between 2009 and 2012.1 Reasons cited in the complete response letters issued for these applications covered a number of areas, including safety, efficacy, regulatory, labeling and quality related issues. Quality- related issues were one of the most prominent reasons for delay of market entry with deficiencies being cited in 20/51 (39%) of applications. GMP inspection failures and data deficiencies contributed equally to the quality citations. The prominence of quality-related issues in the delay of product approvals emphasizes the importance of robust quality programs in drug development. Understanding what elements have posed as hurdles in past development programs will help a sponsor avoid these pitfalls in the future.

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  • Four Team Members to Include When Building Your Software Implementation Dream Team (and Two to Avoid)

    11 March, 2014 by Stephanie Jones, Professional Services Consultant, MasterControl Inc.

    According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abando

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  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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