MasterControl - Quality & Compliance Management PodCast - MasterControl

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Creating a Strategic Master Validation Plan Jul 31, 2019

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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/.

Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation Feb 25, 2019

Show notes

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.

Jan Olson of EduQuest talks about MasterControl and Cloud vs hosted Systems Feb 01, 2019

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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.

RIMs "By the Numbers" A Quick Look Guide to Inproving Your Global Submissions by Alex Butler Nov 16, 2018

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Advancing Beyond CAPA Compliance Using Innovation for Improvement and Growth - Part 2 Aug 27, 2018

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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.

Advancing Beyond CAPA Compliance Using Innovation for Improvement and Growth - Part 1 Aug 27, 2018

Show notes

Corrective and preventive action (CAPA) guru Ken Peterson breaks down the quality event management process and provides tips to help companies avoid CAPA overload while spurring creativity. This first of a two-part series on CAPA innovation demonstrates how organizations can implement creative techniques to advance their quality programs beyond common (and often inefficient) CAPA management. Ken discusses the importance of project scope and compares and contrasts CAPA improvement and CAPA compliance. Walking through the fundamental steps of CAPA improvement, he also shows how companies can catalyze CAPA innovation by asking key questions that allow them to envision and construct inventive new solutions.

Examining Operational Efficiencies Achieved in the GMP Space and Effectively Translating Them to GCP Jun 02, 2017

Show notes

Recorded at the 8th Proactive GCP Compliance Conference in Philadelphia, MasterControl director of pharmaceutical and biologics solutions Patricia Santos-Serrao, RAC, explains how organizations can apply their existing GMP methodologies and best practices into GCP areas. She discusses the various processes that comprise a Quality Management System (QMS) and tells how they can be adapted to bring clinical quality and clinical operations together.

The importance of strong management systems in process industries Sep 26, 2016

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MasterControl strategic partner Walt Murray explains how his company's QMS functions across multiple industries -- not just life sciences.

The Challenges Facing Today's Quality Assurance by Dr. Andrew Waddell Aug 09, 2016

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Dr. Andrew Waddell, a seasoned QA pro and director of the Scotland-based GxP consultancy TMQA delivered the keynote presentation, titled “The Challenges Facing Today’s Quality Assurance,” at the 2016 Masters Conference, the annual event for MasterControl enterprise quality management software (EQMS) users in Europe. Drawing from his unique life experiences and 37-year tenure in QA, Waddell examined five lesser-known aspects of QA that challenge the relevance of a nearly 40-year-old regulation (21 CFR Part 58) and point to an exciting new future of quality.

Process Validation Planning: Have You Made the Leap into the 21st Century? Apr 11, 2016

Show notes

At the 2016 MD&M West conference Walt Murray, Director of Quality & Compliance Services, for MasterControl, spoke as part of the show’s focus on enhanced quality assurance and risk management. Mr. Murray covered “Process Validation Planning: Have You Made the Leap into the 21st Century?” The presentation provide useful information regarding the FDA's Center for Devices and Radiological Health (CDRH) recent posting “CDRH Fiscal Year 2016 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.”

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