MasterControl Speakers Bureau - Presentations

At MasterControl, we are industry experts at helping life science companies automate processes by implementing easy-to-use software solutions. We understand industry best practices, regulatory requirements, risk management and validation, and other areas of key importance to life science companies.

In addition to our software offerings and professional services, we provide a number of free-of-charge presentations designed to support the industry, provide expertise in various life science-related areas, engage life science thought leaders, and lend our insight to current issues. Examples of topics include:

How to Automate Training Control Processes to Comply with FDA and ISO Requirements;

How Automating Document-Based Processes can Boost your Company's Financials;

How to Meet ISO 1400 Quality Standards, etc.

For the complete list of topics (which is continuously growing), please refer to the titles below. Members of our Speakers Bureau travel worldwide to give presentations at conferences, conventions, seminars, etc. If you would like to talk to us about booking a presentation, or if you just have a question about our Speakers Bureau, please contact Michael Bothe at 1 (801) 365-1211. You may also contact him by email at Remember, all of our presentations are free-of-charge.

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MasterControl Presentations

Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations
Most FDA violations involve: (1) not having procedures that conform to regulations; (2) having adequate procedures, but not following them; or (3) having adequate procedures and following them, but not having adequate documentation to prove it. This presentation discusses the ten corporate areas most vulnerable to one of these problems.
Six Ways to Optimize Your Quality Management System to Ensure FDA and ISO Compliance
An optimal quality management system is the foundation for long-term regulatory compliance and enduring market success. This presentation provides tips and suggestions that you can use to optimize your quality management system in order to ensure high-quality products/services and continuous compliance.
Drug and Device Accountability Act of 2008
This presentation discusses a bill introduced to the U.S. Senate in 2008 that would require company executives to certify the accuracy and regulatory compliance of their product submissions. Certifying false or misleading information, even unknowingly, would result in high fines to companies and their senior officers, who would also face stiff jail sentences.
Final FDA Rule on Dietary Supplements
The FDA's Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule (21 CFR Part 111) requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations. This presentation discusses specific requirements of the rule, the companies affected, and the challenges that these companies will face.
How 21 CFR Part 111 Helps Dietary Supplement Companies
The FDA's final rule on dietary supplements attempts to protect consumers while quelling fears of FDA "over-regulation"—a prospect that alarms not only consumers but also manufacturers and distributors of dietary supplements. This presentation discusses how the FDA orchestrates this balancing act, to the benefit both of consumers and dietary supplement companies.
How Software Helps Pharma/Biotech Maximize the Value of External Resources
Pharmaceutical and biotech companies rely on external resources to finance products, expand geographically, lower costs, and, ultimately, increase revenues. This presentation examines how modern technology can help companies (a) secure the funding they need to finance new products, (b) lower costs through strategic outsourcing, and (c) maximize the benefits of mergers and acquisitions.
The Pharmaceutical Industry's Transition to Electronic Processes
This presentation explores the history of the FDA's initiative to encourage the early adoption of new technology by the pharmaceutical industry. It begins with the role played by the International Conference on Harmonization (ICH), which, in 1994, planted the seed for the FDA's current push to get all companies onboard with modern technology.
How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
This presentation discusses the challenges pharmaceutical companies face in controlling the hundreds of thousands of documents generated for a product during the preclinical through post-market phase, and how GXP process and document management software solutions address each challenge, to improve product quality and accelerate time to market.
GAMP®5: A Risk-Based Approach to Compliant GxP Computerized Systems
In February 2008, the new GAMP®5 guidelines were released at the ISPE Manufacturing Excellence Conference held in Tampa, Florida. This presentation covers the guidelines, which are based on risk assessment, and are thought to be the latest, most up-to-date thinking on cost effective approaches to the validation of GXP computerized systems.
SOP Management as a Compliance Tool in FDA and ISO Environments
This presentation explores the universal need for SOPs in literally every manufacturing environment. It outlines the challenges of trying to maintaining accurate, up-to-date SOPs using a paper-based system, and the many ways in which a modern, integrated software system can help companies overcome these challenges.
How to Successfully Manage your Suppliers and Ensure Product Safety and Compliance
The recent Heparin tragedy is a grim lesson that all companies can learn from. It illustrates the importance of taking responsibility not only for a company's products, but also for its suppliers, CROs, CMOs, and other contractors. This presentation discusses the ways in which modern technology can help companies do so, and prevent future tragedies.
Automating Electronic Engineering Change Management (ECM) Systems to Reduce Compliance Risk and Improve Product Quality
From medical devices to forklifts, all products undergo design changes at some point in their lifecycle. The modifications needed may be minor and simple to implement, or complex, involving several assemblies. This presentation discusses the importance of implementing a Web-based ECM system to streamline and establish control over the change process.
Validating Software Systems to Comply with CGMP and 21 CFR Part 11 Regulations
This presentation discusses the importance of purchasing electronic quality management systems from manufacturers that specialize in 21 CFR Part 11 and computer systems validation. It presents an overview of the validation process, and explains how a knowledgeable, "validation-ready" supplier can make the process much easier and faster.
21 CFR Part 11 Risk of Noncompliance
After 21 CFR Part 11 took effect in August 1997, it became apparent that the FDA's intentions were not always crystal clear. This presentation discusses the FDA's decision to re-examine Part 11, and (in 2003) issue an interim document to help clarify 21 CFR Part 11, using a narrow, risk-based approach.
Noncompliance to FDA Quality Standards: What's the Risk to Executives?
Although life science companies rely on the expertise of dozens to hundreds of employees, ultimately, the responsibility for quality and compliance lies squarely on the shoulders of upper management. Corporate executives and directors, both financially and personally, can suffer grave consequences for non-FDA compliance. Exactly what the risks are, and how upper management can protect itself is the subject of this presentation.
Advantages to Risk-Based Validation
This presentation discusses the ways in which companies can contain validation costs. One way is to evaluate their software and make their own determinations, based on risk assessment, about how much validation is really necessary. Another way is to audit their software vendor and use the vendor's documentation to reduce their validation burden.
Risk Management: Best Practices for Medical Device Profitability
Based on independent research and analysis of the best practices necessary for medical device companies to increase their profitability in a rapidly changing global environment, this presentation discusses the ways in which many medical device companies fall short, both in terms of their practices and their systems.
The Importance of Effective Quality Management in Complying with the European Union's GMP Standards
The European Union (EU) pharmaceutical market is composed of 27 member states. To sell most pharmaceutical products in the EU, manufacturers must comply with numerous European Commission regulations and directives, including GMP principles and guidelines under the Commission Directive 2003/94/EC. This presentation covers the key principles in this directive.
Five Ways MasterControl Ensures System Compliance with 21 CFR Part 11
This presentation offers tips on good system implementation practices to help companies strengthen their validation documentation and assure Part 11 compliance. The suggestions cover recommendations for system SOPs, user authentication, access security, audit trail controls and record retention policies.
21 CFR Part 11 - Are You Ready for an FDA Inspection?
In preparing for an FDA inspection, organizations frequently wrestle with the problem of whether or not a process or system falls under the aegis of 21 CFR Part 11. This presentation provides practical suggestions on how organizations can go about educating themselves on this and other issues prior to an FDA inspection.
What's the Return on Investment?
Using statistics from an ongoing study at the Tufts Center for the Study of Drug Development, as well as information from the Forrester Research survey (2005) and other sources, this well-researched presentation pretty much debunks the reasons commonly given by life science companies for not adopting modern technology.
Calibration Software: The "Buck Starts" at User Requirements
Complying with calibration requirements is often best accomplished with calibration management software (CMS), which results in many benefits to companies. This presentation details some of these benefits and provides practical suggestions for avoiding what it terms "backwards shopping" by assessing a company's user requirements upfront before considering a purchase.
How to Kick-Start Your CAPA Process
Two key ingredients to building an effective CAPA process involve understanding the object of the problem and the defect of the problem—in other words, "What is wrong with what?" This presentation discusses how to proceed after taking this first critical step, and provides a case study to illustrate the process.
Software Automation in the Blood and Biologics Industry
This presentation describes the software relevant to the blood/biologics industry that can help companies improve process efficiencies and decrease business costs. The software categories discussed include: electronic document management (EDM), enterprise resource planning (ERP), laboratory information management systems (LIMS), donor management information systems (DMIS), manufacturing execution systems (MES) and quality management systems (QMS).
Automating Training Control Processes to Comply with FDA and ISO Requirements
Well-managed training programs minimize the risk of non-compliance and improve product quality. This presentation discusses the challenges of not having automated training control processes, and the colossal benefits of having such processes to manage and track the hundreds to thousands of job functions that require employee training.
Effective Nonconformance Management: Key to FDA and ISO Compliance
A product's quality, reliability, and safety depend to a large extent on its conformance to specifications, whether one is talking about pharmaceuticals, medical devices, or any other consumer product. This presentation discusses the challenges involved in establishing an effective nonconformance disposition process, and how a successful program can be easily implemented.
Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
A lack of cooperation between product development engineers and quality professionals often results in delays and inefficiencies that can translate into millions of dollars during the course of a product's development. This presentation explains how a cross-functional team approach can bridge the gap, enabling companies to market new products more quickly, efficiently and economically.
Simplifying CAPA: Seven Steps to a Comprehensive CAPA Plan
Troubleshooting problems, as well as attempting to identify and prevent potential problems, are typical activities for most businesses. The missing element is often adequate documentation of the actions taken, which would provide important historical data for continuous quality improvement. This presentation identifies seven steps involved in initiating a comprehensive troubleshooting (or CAPA) plan.
The Top Five Challenges of BOM Management
When it comes to the successful financial management of a product under development, one tool in particular stands out: BOM management. This involves engineering, quality, purchasing and manufacturing, and usually results in a lengthy list of management challenges. Some of the more salient challenges and their potential solutions are addressed in this presentation.
Top Five Ways the Automation of Document-Based Processes Can Boost a Company's Financials
In today's fast-changing, global marketplace, innovation and business growth are next-to-impossible without the aid of modern technology. This presentation discusses the top five benefits of automating document-based processes, such as data management, collaboration and audit operations.
ISO 14000 Quality Standards
This presentation explains some of the requirements of the ISO 14000 series of international standards, developed to incorporate environmental considerations into the product development lifecycle. The presentation also illustrates how an automated quality management system can facilitate compliance with environmental policies.
Quality Audit - A Tool for Continuous Improvement and Compliance
In both the ISO and FDA environments, internal quality audits are critical. The focus of an audit can be a product/service, a process, or a system. This presentation describes the internal quality audit process, the challenges involved in conducting audits in a paper-based system, and how an automated system can help.
How to Launch an Effective Internet/Online Marketing Campaign
Internet marketing involves a comprehensive online media strategy for engaging potential customers through search engine marketing (SEM) and optimization (SEO), pay/click (PPC) ads, banner ads on specific websites, e-mail marketing, and the use of other Internet tools, all of which are explained in this presentation.

MasterControl Partner Presentations

Software Automation Trends in the Medical Device Industry
Successfully bringing a new medical device to market is becoming increasingly difficult in the wake of growing competition and broader regulatory constraints. This presentation discusses the ways in which software solutions available to medical device manufacturers can help by increasing a company's efficiency and productivity.
The FDAs Growing Emphasis on Human Factors
According to the FDA, more than one-third of medical device incidents involve use error, and more than half of device recalls for design problems involve the user interface. As a result, the agency has strengthened its initiative requiring medical manufacturers to conduct human factors studies, analyses, and tests. This presentation discusses the major implications of the Human Factors initiative, and how companies can reduce human error.
Speaker: Patricia Patterson
Best Practices for Managing an FDA Investigation
Quality audits don't have to be stressful events. The level of preparation within your organization makes a significant difference to your level of success. This presentation by an industry expert covers the preparation necessary before an FDA audit, how to execute a successful audit and the best course for remediation after the audit.
Speaker: Larry Mager, VP Consulting, PathWise
Quality System Regulation for Medical Devices: Management Responsibility and Control
This presentation provides a brief overview of ISO 13485 and the Quality System Regulation, providing a common frame of reference for individuals at all levels within an organization. Participants will determine appropriate resolutions for audit finding examples and common issues noted in warning letters, and discuss management responsibility and control. Activities will make use of multiple reference sources, including the preamble and relevant FDA guidance documents.
Speaker: Larry Mager, VP Consulting, PathWise
Effective CAPA Management: How to Integrate a Risk-Based Filter into the Quality System
Because the FDA stresses risk-based quality management, many life science companies assign nonconformances a priority based on risk assessment. Eventually, however, everything gets funneled through the system into CAPA. This presentation discusses a method of managing nonconformances through a risk-based filter gateway, which helps you discriminate between nonconformances that should be a CAPA and those that should remain within their respective areas of the quality system.
Speaker: Nathan Conover, Sr. Partner, PathWise
How to Conduct Effective Supplier Quality Audits
Through reading, lecture, discussion, role playing, and practical exercises, this presentation prepares individuals to become effective supplier quality auditors. Its focus in on developing the knowledge and skill sets necessary to accomplish tasks relating to pertinent regulatory requirements, guidelines, and standards. The presentation also covers scheduling, planning, and performing the audit, and writing the audit report.
Speaker: Larry Mager, VP Consulting, PathWise
How to Eliminate Repeat CAPA Investigations
Despite the fact that, after a CAPA investigation, most regulated organizations implement the recommended corrective action(s), repeat investigations account of up to 30% of all open investigations—that's 1 out of every 3. This presentation examines the top reasons for repeat investigations and offers tips and techniques to reverse this trend.
Speaker: Nathan Conover, Sr. Partner, PathWise
CAPA for Life Sciences
The life science industry needs trained people they can count on to identify and investigate root causes and effectively implement CAPA solutions. This presentation is designed to help develop this expertise by providing individuals with the skills and tools necessary to become superb investigators and problem solvers.
Speaker: Nathan Conover, Sr. Partner, PathWise
Integrating ISO 14971 Risk Management Techniques into your Quality System
Effective risk management is essential to a product's development and post-production success, especially for companies under increased regulatory scrutiny. This session provides insight into industry standards and offers techniques that medical device risk management professionals can use to implement ISO 14971 in their quality systems.
Speaker: Nathan Conover, Sr. Partner, PathWise
Integrating ICH Q9 Risk Management Techniques into the Quality System
For products under regulatory scrutiny, effective risk management is critical both to product development and to post-production success. In 2005, ICH Q9 became the standard for risk management throughout the product development, manufacturing, distribution, and inspection and review cycles. This presentation discusses the ICH Q9 risk management standards and how to implement them into your organization's quality system.
Speaker: Nathan Conover, Sr. Partner, PathWise
Conducting and Documenting Quality System Investigations
Accurate and thorough documentation is critical in an FDA regulated environment. The challenge is to capture all necessary information in a timely fashion from a diverse workforce consisting of individuals with technical and non-technical backgrounds. This presentation addresses ways in which to overcome this challenge, in order to effectively conduct and document quality system investigations.
Speaker: Nathan Conover, Sr. Partner, PathWise
Analytical Problem Solving: Tips and Techniques to Identify and Correct Root Cause
Getting burned by fire fighting? Too often expensive problems are never resolved and reoccur because those working on them lack the experience or skills needed to quickly find the root cause. Good problem solvers are worth their weight in gold, and in most companies are just as rare. In this session, participants learn the skills needed to successfully identify, correct and prevent problems.
Speaker: David Baldwin, Sr. Partner, PathWise