2-Day Seminar: Quality Management System - A Modern Approach to Designing\, Implementation and Maintenance of a QMS (Boston\, United States - April 4-5\, 2019) - ResearchAndMarkets.com

2-Day Seminar: Quality Management System - A Modern Approach to Designing, Implementation and Maintenance of a QMS (Boston, United States - April 4-5, 2019) - ResearchAndMarkets.com

DUBLIN--()--The "2-Day Seminar: Quality Management System: A Modern Approach to Designing, Implementation and Maintenance of a QMS" training has been added to ResearchAndMarkets.com's offering.

This course/seminar will help you create a system that supports business, and will aim in reducing the required cost and resources.

A robust QMS has always been considered the cornerstone of a well-functioning and healthy organization. However, time and again, we realize challenges when implementing, executing, or trying to improve such systems. Internal departmental discussions, jurisdictional arguments, lack of parts of the organization's fullhearted commitment to quality or the void in empowering the staff's ownership of compliance and quality in their own daily operations. These are just a few challenges that we all can recognize and have experienced through different means.

The expectations have been there for decades. Most of us in the industry are quite familiar with what the requirements are. Whether it is US FDA, EMA, MHRA, ANVISA, CFDA, etc., as long as they are applicable, we need to comply with them. Still, we are struggling with how to implement these most efficiently. We keep asking ourselves, How can that be? How do we address and overcome these challenges? Is our QMS robust and does it serve its purpose as long as it complies with external requirements, or do we have any internal expectations or other best practices, that should be formalized and adhered to?

This seminar helps to streamline and to formalize your processes and QMS structure to serve your business and your commercial success. It is acknowledged that a QMS does not serve its purpose if it is not supporting a successful, productive and rewarding commercial operation.

It is believed that proactive prevention of failure through initial investment is a much less expensive endeavor than immediate short-term cost savings extended by long-term, reactive, repetitive and costly corrections. Not only this is an inefficient waste of resources, but it is also discouraging for involved staff and would cause loss of employee loyalty.

Program Objectives

  • Help you assess the status of your current system
  • Identify your expectations of a well-functioning QMS, based on your organization's needs
  • Help you make a GAP-analysis identify what is required for your system to fulfill your expectations
  • Provide you with the necessary tools to revise the system in accordance with an identified pathway
  • Provide you with the expected elements required to maintain and improve the system throughout its life-cycle

Agenda

Day One - 8:30 AM - 4:30 PM

Lecture 1: Introduction and Background

  • Introductions/Participants' Understanding/Participants' Objectives for the Course (Please come prepared to discuss)
  • Regulatory Focus, and some of the applicable Requirements

Lecture 2: Understanding QMS

  • What attributes would apply to a favorable vs. unfavorable QMS
  • Functional, Departmental, Internal/External Interfaces
  • Quality Metrics
  • Continuous Improvement

Lecture 3: Quality Risk Management

  • Process Risk Management
  • Quality Risk Management
  • Risk Register

Lecture 4: The Concept of Quality

  • Quality Function
  • QA
  • QC
  • Qualification & Competence

Day Two - 08:30 AM to 04:30 PM

Lecture 5: Management Role & Responsibilities

  • Corporate Commitment to Quality
    • Quality Metrics
  • Audits & Inspections
  • Understanding and Defining Compliance

Lecture 6: Company's Infrastructure

  • Types of Operations
  • Geographical locations of operation and marketing
  • Company hierarchy and lines of reporting
  • Utilized Systems (i.e. automated vs. manual, electronic vs. paper-based)

Lecture 7: QMS Elements

  • Complaints
  • Deviations and CAPAs
  • Training
  • Outsourcing
  • Audits
  • Continuous Improvement
  • Change Management
  • Computerized System
  • Validation
  • Facilities & Equipment
  • Risk Management
  • Supply Chain/Good Distribution Practice
  • Data Integrity

Quiz: Multiple Choice

  • QMS Test (expected to answer 80% correct)

For more information about this training visit https://www.researchandmarkets.com/research/f9kmlx/2day_seminar?w=4