MasterControl - Quality & Compliance Management PodCast
Episode 3: Achieving and Maintaining an Audit-Ready State

Episode 3: Achieving and Maintaining an Audit-Ready State

August 10, 2020

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.
Episode 2: Elevate Your Quality Management System

Episode 2: Elevate Your Quality Management System

August 7, 2020

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.

Episode 1: An Introduction to Quality Management System (QMS) for Regulated Industry – Next Steps

Episode 1: An Introduction to Quality Management System (QMS) for Regulated Industry – Next Steps

August 7, 2020

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.

Cloud Security Myths - Part 2 Security and Validation Webinar Series

Cloud Security Myths - Part 2 Security and Validation Webinar Series

March 19, 2020

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.

Cloud Education - Part 1 Cloud Security and Validation Webinar

Cloud Education - Part 1 Cloud Security and Validation Webinar

March 19, 2020

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.

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

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

August 14, 2019

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.

Creating a Strategic Master Validation Plan

Creating a Strategic Master Validation Plan

July 31, 2019

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

Accelerating Business Momentum Through Strategic, Risk-Based Technology Validation

February 25, 2019

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:

  1. Complete a risk and opportunity planning worksheet.
  2. Strategic planning for the various conditions that trigger validation(s).
  3. Map an MVMP for an innovative organization.

 

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

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

February 1, 2019

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

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