Gain the practical quality management skills you need to thrive in today's increasingly competitive global marketplace. You'll learn from the very best-seasoned quality and compliance professionals who've trained investigators from the FDA and hundreds of regulated life science and manufacturing organizations worldwide. A variety of teaching methods are employed, including lecture, discussion, and role playing, to keep you engaged and teach you proven quality management skills you can put to work immediately.
Click a workshop topic below to jump to the agenda.
Getting the Most Out of Your CAPA System & Becoming a Superb Investigator
CAPA is more than just having a good response to solving problems and correcting their respective causes. CAPA is a process that manages how issues are input, processed and funneled into your quality system and requires critical thinking for the successful identification of problem resolution, the implementation of that resolution, and the subsequent verification of the resolution's permanency. The skills and tools required for successful CAPA management can be mastered and utilized with the help of MasterControl and Pathwise's CAPA training workshops.
Course Overview
The CAPA training courses will also provide skills and tools to eliminate the following common CAPA problems:
The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.
MasterControl teamed up with PathWise to build an audit course that is designed to effectively teach and develop the skills required to become superb auditors. The course is also designed to meet the rigorous standards of regulated industries and apply those skills in industry.
The Problem
Many organizations don't have the luxury of hiring well-seasoned professional auditors. They must develop them from within and take on audit responsibilities in addition to other job tasks. This causes stress and often results in reduced performance from even the best performers. In addition to these difficulties, audit pains common to organizations include:
The Solution
The QMS Audit workshop incorporates a proven methodology to teach critical thinking skills that will help anyone deploy and follow a best-practice audit system. Workshop participants will learn the best practices of audit planning, audit preparation, audit administration, client communications, observation writing, and reporting. The methodology taught throughout the workshop is in accordance with regulatory expectations, is easy to understand and is result-driven.
Course Overview
Skills Learned
Throughout the course, participants improve their ability to:
Application
QMS Audit Workshop participants will gain the proficiencies necessary to solve real audit problems and develop audit skills that enable them to be superior auditors. The skills taught throughout the course can help participants plan, prepare, perform, and publish flawless audit reports. The audit processes taught in the course allow participants to create their own replicable, audit-ready processes.
Integrate Your Quality System with a Risk-Based Approach that Manages Hazards and Harm in a Auditable, Effective Manner
QRM is more than having a good "feel" for assuring outcomes to processes; it is a multifaceted process that manages how issues are handled in order to avoid, reduce or even eliminate hazards and harm in any complex operating environment. This comprehensive course will teach you the risk-based approach you need to effectively evaluate risk and successfully identify the events that create potentially unsafe or harmful conditions. Upon completion of the course you will possess the confidence and knowledge to develop and implement an effective global risk management strategy - and the ability to translate your company's compliance commitments into an effective risk-based approach.
Course Overview
This QRM training course will also provide the skills and tools you need to eliminate the following common QRM issues:
The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.
Learn How an Integrated Supplier Quality Management Approach Can Benefit Any Sector of Business That Operates in a Regulated Environment.
The FDA has already weighed in on the importance of adapting more rigorous supplier controls, and its emphasis on the link between supplier control and risk management will only continue to increase. To meet these elevated industry standards, manufacturers must implement an effective supplier acceptance approach with subsequent verification and preventive controls. This requires more than having an Approved Supplier List; it requires a dynamic process that manages how assessments, decision making and planning reduce or even eliminate risk in supply chain activities. Outsourcing can increase your operational and compliance risks - particularly if your suppliers are not qualified or lack the appropriate level of control in their quality processes. MasterControl's SQM workshop will teach you how to evaluate your organization's compliance against the FDA's current purchasing control requirements, as well as how to implement effective controls for all of your supplied products and services.
Course Overview
The Supplier Quality Management workshop will also the provide skills and tools you need to eliminate the following common issues:
The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.
Master the Good Documentation Practices That Can Dramatically Improve Your Organization's Efficiency and Effectiveness
Regardless of sector, size, structure, or maturity, highly regulated organizations must establish appropriate quality management systems (QMS) to be successful. The most important aspect of any QMS is the way in which it is documented to manifest the system hierarchy. The workshop explores the process model approach for the creation and operation of an effectively documented QMS. The levels of complexity, integration, and application are examined to bring about a streamlined system that is effective, efficient, and not burdened by superfluous documentation.
Course Overview
The QMS Documentation training courses will also provide the skills and tools you need to eliminate the following common documentation problems:
The course is taught using a blended approach of classroom and real-life application. This "how-to" approach significantly increases knowledge retention and allows participants to apply the skills as they learn in a dynamic setting.
For more information about any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.
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