MasterControl - Quality & Compliance Management PodCast

Manufacturers have been conditioned to believe the myth that an expensive, complex MES is the path to automating the shop floor. But new technologies today are providing smarter, faster, and less expensive alternatives – where production records, training documents, SOPs, and more are quickly and cost-effectively digitized under one platform. And the simplicity of these systems extends to user adoption and configurability that easily maps to your existing processes. This webinar will explore alternative technology for paperless manufacturing that integrates with existing ERP and QMS investments for a fully connected manufacturing experience. It will showcase manufacturers who have implemented MasterControl Manufacturing Excellence™ and their simplified path to digital adoption, plus metrics achieved by improving data integrity and right-first-time (RFT) metrics, reducing deviations, shortening review time, and accelerating product release. For manufacturers that have been slow to adopt digital technology for fear that solutions are too complex or costly, this webinar will present a smarter, more cost-effective path to digital adoption and manufacturing excellence.

Innovation and technology in the life sciences made it possible to develop the COVID-19 vaccine in record time. With inspiring advances like that, the question becomes: “How can we still be using paper?” The pandemic truly highlighted the constraints of paper and siloed systems, and maybe that’s a good thing, because it has also propelled companies to think seriously about digitization.  Here’s what you can expect with connected systems: • Visibility between quality and manufacturing functions. • Say goodbye to deviations, nonconformances, and scrap.  • Production record review in record time.  The good news: integrating digital systems is not as hard as you think, just start with preparation. When firms plan their efforts, they can start small and scale quickly to see improvements.  Key takeaways for this presentation include: • How digitization gives you a competitive advantage and increases resiliency.  • Benefits of integrating quality and production. • The ROI for integrating quality and production and how to calculate that. • How to identify the right system for your organization. Presenters Brian Beckstead, Product Manager, MasterControl Jamie Nowacek, Product Manager, MasterControl

COVID-19 exposed weaknesses in manufacturing, but those weaknesses were impacting shop floors long before the pandemic. Thankfully, the industry march towards digitization is offering new levels of flexibility. And manufacturers will benefit both during COVID-19 and beyond. Join us as we explore how to: • Improve manufacturing time by ditching paper-based processes. • Implement fully configurable digital systems. • Increase visibility and communication on the shop floor. • Make it easier for workers to operate remotely. • Maximize productivity, eliminate data input errors, and streamline the compliance process. Don’t miss this chance to explore the new solutions that are essential in maintaining your competitive edge. Presenters:  Brian Curran, SVP of Strategic Growth, MasterControl and Katie Farley, Product Manager, MasterControl   Link to Webinar Replay. https://www.mastercontrol.com/learning-center/all-videos/how-digitization-facilitates-safe-and-connected-operations-during-and-beyond-post-covid-19-mfg

Since the COVID-19 pandemic started over a year ago, businesses have learned that constant change is the new normal. There will always be outside forces that companies need to adapt to, many of which are unforeseen, and there’s a continual need for resilience. One of the things that MasterControl customers have noticed is how going digital and using our solutions helps them when these issues arise. They can communicate more effectively, keep their operations going, and maintain quality with minimal interruption. We’ve already moved our customers from paper to digital — now we’re focused on data intelligence. Data intelligence is all about using artificial intelligence (AI) and machine learning (ML) to make data-driven decisions. Or, in some cases, simply enabling the applications to make those decisions without human involvement. This level of connectivity brings quality into every part of your organization, giving you a true culture of quality. Key takeaways from this session include: How common quality pains are solved by digitizing. How a connected platform allows improved agility/resilience. The benefits of connecting quality data and using it to drive decision-making. How a culture of quality driven by connected data and metrics can help your business thrive.

COVID-19 has exposed issues within the manufacturing industry, which may never be the same. The global pandemic illustrates why it is critical for manufacturers to be adaptable. Forward-thinking companies need to adopt the right technology now to ensure they can adapt to the current environment and prepare for the future.

The traditional approach to quality in the life sciences has mainly been focused on control and standardization. As the industry continues to evolve, companies are finding it necessary to incorporate flexibility and improved collaboration into their quality management methodologies. These shifts are creating exciting opportunities to leverage emerging technologies like artificial intelligence, machine learning and natural language processing for data collection, analysis and connectivity.

Outsourcing isn’t a trend in the life sciences – it’s the new way of doing business. MasterControl Executive Vice President of Product Matt Lowe discusses the challenges posed by modern business ecosystems and the criticality of extensible and flexible quality management systems. Lowe will examine the many ways technology platforms can help companies expand quality’s footprint while also enhancing their control over operations and data. He is joined by Matthew Seitz-Paquette of Fagron who will examine some real-world applications and show the power of QMS extensibility by explaining how the personalized medicine and compound pharmaceutical company has leveraged advanced digital tools to align quality processes between multiple global sites and streamline its training processes. Lowe and Seitz-Paquette will share examples of the benefits that can be achieved by effectively connecting quality data and processes with robust platforms.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 10 of this 10-part series, SVP of Strategic Growth Brian Curran and Principal Product Management Director Terrance Holbrook talk about how to stay flexible for future changes by digitizing. Key takeaways include:• The adaptability of a digital production records system.• What to look for in a quality management system (QMS).• The benefits of risk-based validation.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 9 of this 10-part series, Senior Director Public Relations and Content Jennifer Hurst and Principal Product Management Director Terrance Holbrook talk about how digitizing will help companies prepare for the aftermath of the pandemic. Key takeaways include:• How the pandemic has shaped exemptions.• What companies can do once the pandemic has resolved.• How a culture of quality prepares your company for the future.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 8 of this 10-part series, Product Manager Kim Jackson and Principal Product Management Director Terrance Holbrook talk about digitizing quality event management and how it can improve an organization. Key takeaways include:• Importance of process improvement in QEM.• Problems solved by digitizing QEM.• Factors to keep in mind while digitizing.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 7 of this 10-part series, Product Manager Katie Farley and Principal Product Management Director Terrance Holbrook talk about best practices for and benefits of digitizing manufacturing. Key takeaways include:• How to start your digital journey.• Design best practices for optimizing master batch records and DHRs.• How connected data helps you achieve OKRs and KPIs.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 6 of this 10-part series, Product Manager Katie Farley and Principal Product Management Director Terrance Holbrook talk about digitizing your SOPs and work instructions. Key takeaways include:• How to digitize your SOPs and work instructions.• The biggest challenges and how to overcome them.• The benefits of going digital.

In Episode 5 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook talk specifically about how digitizing helps with the complexity of compliance. Key takeaways include: How to be audit ready. Requirements of 21 CFR 210-211. How digitizing streamlines processes.

In Episode 4 of this 10-part series, Product Owner Manager Dave Latimer and Principal Product Management Director Terrance Holbrook discuss FDA requirements and how to comply with them. Key takeaways include: Bridging the gap between quality and manufacturing. Improving compliance processes. Enhancing best practices to avoid common pain points.

In Episode 3 of this 10-part series, Validation Product Manager Erin Wright and Principal Product Management Director Terrance Holbrook discuss how companies can be prepared for an audit at any time. Key takeaways include: Determine what’s keeping you from becoming audit ready. Tools to help you overcome those barriers. How to maintain an audit-ready state.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 2 of this 10-part series, SVP of Strategic Growth Brian Curran and Principal Product Management Director Terrance Holbrook discuss the cost benefits of a QMS. Key takeaways include:•            The cost of a QMS is an investment.•            The cost savings from having a good QMS.•            The associated cost reductions.

Presented by MasterControl in collaboration with MedTech Association and MassMEDIC. In Episode 1 of this 10-part series, Vice President of Product Rajesh Talpade and Principal Product Management Director Terrance Holbrook explain the basic ins and outs of optimizing a QMS. Key takeaways include:•            How to expand your QMS.•            Why paper slows down production.•            The responsibilities of management.

This webinar dispels the most common myths about cloud security, such as it is still an immature technology, storing data on your own server is safer, cloud service providers don’t understand the specific data management needs of regulated companies, and more.

Everyone’s talking about the importance of the cloud, but how much do you actually know about it? Because misconceptions abound, we’ve put together a webinar series to cover cloud basics and put to rest any fears you might have about migrating. MasterControl EVP of Customer Success Adam Decaria and GxP-Compliance Consulting CEO James Francum explain cloud environments, the business case for migrating, and how the cloud is affecting the life sciences industry.

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.

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/. 

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.  

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.

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.

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.

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.

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

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.

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.”

MasterControl, Inc., an industry leader in the development of quality compliance and document control software, presents the following audio recording of Paul Sanderson’s paper: “What is the True Cost of Not having an eQMS?” Paul Sanderson leads MasterControl’s Solutions Consultants Group which is represented by experts from the Pharmaceutical, Medical Device, Blood & Biologics and additional high-tech industries. To learn more about MasterControl visit www.mastercontrol.com.

Ken Peterson Provides basic CAPA training using the closed loop methodology.

ISO change is coming your way in the form of an ISO 9001 update. This is a major revision to the standard. ISO experts Walt Murray and Peter Knauer provide an overview of the coming changes in part 1 of a three part video series.

This complementary video from MasterControl demonstrates best practices for quality event management and corrective and preventive actions. The third segment of a three-part series, this webinar is intended to help companies optimize their quality systems by conducting better effectivity checks and management reviews.

Take effective quality actions! This complementary video from MasterControl demonstrates best practices for quality event management and corrective/preventive actions. Second of a three-part series intended to help companies optimize quality systems.

The structure of the new ISO 9001:2015 standard contains ten modules that can be categorized into the plan, do, check, act model. In this second in a three-part video series, ISO experts cover the detail that companies must provide in these ten modules.

Thinking of migrating to the Cloud? Senior Product Manager Vic Gill talks about MasterControl’s Cloud solution, and how it can enhance your business and IT operations without compromising data security. Gill also discusses the pros and cons of Cloud vs. on-premise quality management systems, as well as the different pricing options MasterControl offers its Cloud customers.