MasterControl's Quality Management Workshops Agenda

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.

• Corrective and Preventive Action (CAPA) Management
• Audit Management
• Quality Risk Management
• Supplier Quality Management
• Document Management

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

• Quality Events - Examine the feeders to your CAPA system and learn to manage complaints, deviations, audit findings, and seven other quality events; feeders will also be examined and key questions regarding CAPA forms will be discussed
• Issue Review - Identify and prioritize events based on risk. Set up risk gateways into electronic solutions
• Root Cause Analysis - Investigate systemic issues to identify underlying causes
• Implementation and Effectiveness Checking - Solution selection, verify and validate, implement, monitor and confirm success

The CAPA training courses will also provide skills and tools to eliminate the following common CAPA problems:

• Countless open CAPAs with no resolution and too many people involved
• Internal investigators who can't solve problems and find causes
• Ineffective processes to utilize with personnel presenting data for root cause analysis
• CAPA processes that don't pass global FDA and EMEA standards
• No uniform, solid method for investigating problems
• No process for verifying and validating corrective actions that work

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.

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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:

• No uniform, solid method for audit preparation and execution
• Audit processes that don't meet regulatory (e.g. FDA, EMA) standards or expectations
• Ineffective processes to utilize with personnel when interviewing
• Ineffective decision making and coaching within the audit process
• Poorly written findings that are difficult to interpret
• Misunderstanding of audit roles and responsibilities
• Inappropriate behavior when communicating
• Selection of inappropriate team members

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

• Audit fundamentals - Roles and responsibilities, types of audits, scheduling, and internal vs. external audits
• Audit planning and preparation - Standards/regulations, administration, authority, scope, purpose, type, scheduling, checklist construction, and resource management
• Audit performance - Meetings, interviews, data analysis, findings, writing skills, and feedback
• Audit consolidation and reports - Reports, corrective actions, continuous improvement, department and management accountability

Skills Learned

Throughout the course, participants improve their ability to:

• Organize, prepare and implement the audit process
• Become knowledgeable regarding audit standards and audit techniques
• Listen and investigate
• Interpret and read a variety of reports
• Think objectively and judge with adherence to standards
• Take outstanding notes
• Communicate clearly and succinctly
• Recognize boundaries and constraints
• Write well-documented findings
• Remain calm and composed under pressure
• Exercise diplomacy and maintain professionalism

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.

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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

• Quality Event Evaluation for Risk - Examine the feeder events to your QRM system, and learn to manage complaints, deviations, audit findings, and several other quality events; these feeder events will also be clarified using key questioning patterns regarding QRM.
• Issue Review Risk Analysis - Identify and prioritize events based on risk. Set up risk gateways into electronic solutions.
• Risk Evaluation (Solutions) - Apply critical thinking skills, such as decision making, to implement preventive controls that best address risk.
• Implementation and Effectiveness Checking - Learn how to verify, validate, implement, monitor, and confirm the success of your QRM strategy.
• Post Production Improvement - Develop a compliant, effective means to apply lessons learned from the in-service experience to improve or change your process or product.
• Writing RMP Reports - Learn the steps to writing and documenting your risk management plan clearly and concisely.

This QRM training course will also provide the skills and tools you need to eliminate the following common QRM issues:

• Ineffectively showing traceability of the risk-based approach
• Poor selection of prioritized risks
• Insufficient presentation of data analysis
• An inadequate QRM approach that would not pass global FDA and EMEA standards
• No uniform, thorough method for analyzing risk
• No process for verifying and validating preventive actions for control and outcomes

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.

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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

• Supplier Planning - Understand the interaction of design and development, operations, and quality assurance by using a dynamic control planning (DCP) activity with a risk-based approach.
• Supplier Selection (Potential Suppliers) - Learn how to perform non-exclusive selection and risk analysis on criteria-driven alternatives.
• Evaluation and Acceptance - Build methods for supplier monitoring and metrics. Develop good effectiveness checks that meet GMP agreement components and trigger points for action.
• Finalization of Controls - Transition of methods for meeting acceptance requirements in configuration, acceptance criteria and supplier site validation activity (audits).
• Delivery Measurement and Monitoring - Develop inspection management through control plan documentation. Incorporate quality event management with the initiation of a supplier corrective action preventive action (SCAPA).
• Feedback and Communication - Develop covigilance activity and reporting formats for material change control, triggers for revalidation activity (re-audits), service reporting and more.

The Supplier Quality Management workshop will also the provide skills and tools you need to eliminate the following common issues:

• A subjective selection criteria with "gut feel" justification of approved suppliers
• A non-risk based approach entirely based on the impulsive need for a material or service
• Lack of prioritization due to subjective risk analysis
• No formidable path for evaluating a supplier in the proper context
• Lack of tangible metrics for control and evaluation
• Lack of good reconnaissance of a remote or distant supplier

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.

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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

• Quality Systems - Plan and devise the appropriate system for a sound structure and a thorough application of principles and compliance in a risk-based approach quality plan.
• Formats of Documentation - Review best-practice applications for conveying the meaning of nature of operations within the QMS.
• Continual Improvement - Incorporate an effective venue for improvement actions based on good process evaluation and effective decision making.
• Implementation and Effectiveness Checking - Verify, validate, implement, monitor, and confirm the success of the QMS system through comprehensive and targeted auditing and analytics.
• Change Control - Understand the critical aspects of change in the common cause and effect relationship to avoid reactive and costly actions.

The QMS Documentation training courses will also provide the skills and tools you need to eliminate the following common documentation problems:

• Death by documentation, i.e., the excessive supply of unnecessary information
• A poor audit trail of documents that frustrates auditors and leads to findings
• "Stovepipe" procedures that hinder good communication
• Cumbersome processes that are not in compliance with global regulatory compliance standards
• Lack of continuity between process activities due to poor quality planning
• Poorly developed process documentation that creates ambiguity in work activities

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.

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For More Information on MasterControl Workshops

For more information about any of our quality management workshops, contact the MasterControl Quality and Compliance Consulting Team or call 866.747.8767 today.