18 episodes

To stay competitive in a rapidly advancing global market, manufacturers must be able to produce products of the highest possible quality while maintaining compliance with regulatory standards set forth by agencies such as the FDA and ISO. Quality-minded businesses must always be on the lookout for ways to reduce costs, eliminate risks, increase revenue, and accelerate compliance. Each MasterControl podcast address these topics as well as quality issues, industry trends, and compliance matters in an effort to help manufacturers better achieve their quality goals. Quality and compliance issues such as document management, corrective and preventive actions (CAPA), audits, change control, training, supplier management, nonconformance disposition, customer complaints handling, and similar quality topics are regularly discussed by seasoned professionals with strong quality and compliance backgrounds.

MasterControl - Quality & Compliance Management PodCast MasterControl

    • Government

To stay competitive in a rapidly advancing global market, manufacturers must be able to produce products of the highest possible quality while maintaining compliance with regulatory standards set forth by agencies such as the FDA and ISO. Quality-minded businesses must always be on the lookout for ways to reduce costs, eliminate risks, increase revenue, and accelerate compliance. Each MasterControl podcast address these topics as well as quality issues, industry trends, and compliance matters in an effort to help manufacturers better achieve their quality goals. Quality and compliance issues such as document management, corrective and preventive actions (CAPA), audits, change control, training, supplier management, nonconformance disposition, customer complaints handling, and similar quality topics are regularly discussed by seasoned professionals with strong quality and compliance backgrounds.

    Standardize Your On The Job (OJT) With TWI” by Roger Crist

    Standardize Your On The Job (OJT) With TWI” by Roger Crist

    Description: Roger Crist, a career quality and compliance professional and the quality director at MOXTEK, presents “Standardize Your OJT With TWI” to help illustrate how training impacts quality. Crist demonstrates how on the job training (OJT) when paired with training within industry (TWI) instills in a life sciences or other regulated manufacturer the priorities and company culture of safety, quality and productivity. A standardized approach to OJT can be a key to minimizing and preventing human error on the shop floor that can slow down manufacturing processes. This presentation was recorded at the ASQ Salt Lake chapter’s annual symposium on June 13, 2019, at MasterControl headquarters in Salt Lake City, Utah.
    To get a copy of the slide deck that accompanied this presentation, emails us at podcast@mastercontrol.com and mention the title and presenter of the podcast. For more information about how digital quality and manufacturing solutions can improve your organization, visit MasterControl at mastercontrol.com.

    • 46 min
    Creating a Strategic Master Validation Plan

    Creating a Strategic Master Validation Plan

    Description: Veteran quality and compliance industry consultant Walt Murray shares “Creating a Strategic Master Validation Plan” in which lays out step-by-step how quality and compliance professionals in life sciences and other regulated manufacturers can collaborate with key stakeholders vertically within their organizations to ensure that principles of validation reach across company policies and systems. A strategic master validation plan (SVMP) sets the tone across departments for the nature, depth and extent of documentation needed to execute validation of any given project or software system. Not only does an SVMP act as a guidepost for tracking a project’s progress, but it also inherently provides governance to validation project teams about stakeholder orientation. This podcast was originally recorded at an ASQ industry presentation on Feb. 21, 2019, hosted at MasterControl’s headquarters in Salt Lake City, Utah.
    To get a copy of the slide deck that accompanied this presentation, emails us at podcast@mastercontrol.com and mention the title and presenter of the podcast.
    For more information about how digital validation solutions can assist your organization, visit MasterControl at mastercontrol.com/validation/. 

    • 1 hr 19 min
    Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation

    Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation

    Technology impacts nearly all aspects of a business and can be highly valuable in planning, making confident decisions, and establishing a fully integrated, quality-driven operation. In most organizations, risk and opportunity analysis has become the norm, and optimizing technology is essential for identifying the best course of action for avoiding risks and maximizing opportunities. Ensuring your technology functions as needed to achieve those objectives is best accomplished through risk-based validation.
    To validate technologies, many companies develop some form of process documentation. One highly recommended strategy is to create a master validation master plan (MVMP). This plan consists of key points to consider when dealing with new, revised, and changed technology scenarios. Also, completing aspect and impact analysis for the various technologies in a business can reveal opportunities to advance the organization toward its objectives.
    We will examine a model for risk and opportunity analysis for an organization’s validation planning and mapping efforts.
    Key takeaways:
    Complete a risk and opportunity planning worksheet.
    Strategic planning for the various conditions that trigger validation(s).
    Map an MVMP for an innovative organization.
     

    • 1 hr 19 min
    Jan Olson of EduQuest talks about MasterControl and Cloud vs hosted Systems

    Jan Olson of EduQuest talks about MasterControl and Cloud vs hosted Systems

    Former FDA investigator Jan Olson of EduQuest discusses the pros and cons of cloud servers versus hosted servers in regulated environments. Jan clarifies common misapprehensions about server security concerns and demystifies the groundbreaking cloud technology trends that are catalyzing the regulatory world.

    • 8 min
    RIMs "By the Numbers" A Quick Look Guide to Inproving Your Global Submissions by Alex Butler

    RIMs "By the Numbers" A Quick Look Guide to Inproving Your Global Submissions by Alex Butler

    • 41 min
    Advancing Beyond CAPA Compliance Using Innovation for Improvement and Growth - Part 2

    Advancing Beyond CAPA Compliance Using Innovation for Improvement and Growth - Part 2

    In this second of a two-part series, quality whiz Ken Peterson presents proven methods and tools for generating, evaluating, and categorizing innovative ideas for improving corrective and preventive action (CAPA) programs. The video’s aim is to help companies implement a step-by-step process to transform CAPA improvement ideas into practical and business-focused solutions. Ken demonstrates effective methodologies that help drive successful CAPA improvements and introduces a reproducible six-step process that allows companies to create their own viable CAPA solutions. He also provides strategies and sequential principles for refining your CAPA innovations, eliminating risk, and obtaining buy-in and acceptance of new solutions. Ken’s philosophy of CAPA innovation proves that it’s usually possible to learn more from occasional failures than from initial successes.

    • 34 min

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