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Healthcare 2021 - 6-Hour virtual Seminar on Evolution of the Quality Management System - How to go from Surviving to Thriving



VenueOnline, USA - United States USA - United States

KeywordsHealthcare; Pharmaceutical; Medical online training


Topics/Call fo Papers

This 6 -hour virtual seminar will help you to develop a Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.
The regulations require that manufacturers "establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured".
This webinar will cover the basics of how to establish and maintain a suitable QMS including:
The basic requirements
Management Responsibility
Quality Audit
QMS structure
Quality policy and objectives
Quality manual
Standard Operating Procedures, Work Instructions, Forms, etc.
Levels of maturity
An efficient, effective QMS sends a message to the FDA and other regulators that your QMS is complete, accurate, and consistently followed. More importantly, it ensures that your personnel can consistently and accurately meet requirements resulting in correct outcomes and quality work.
Why you should attend
An ineffective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees. Even worse it can lead to inconsistent or poor product quality including non-conformances, complaints, and even recalls. And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality. An inefficient QMS results in wasted time, money, and missed opportunities. It is imperative that medical device companies can effectively and efficiently establish a QMS.
In this 6-hour virtual seminar, we will explore the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
Learning Objectives
Overview of the Regulations
Essentials of an effective QMS
Essentials of an efficient QMS
Lessons learned and common Mistakes
Maturity modeling
Improvement tools
Best practices
Preparing for an FDA inspection
Who Will Benefit
Individual contributors new to a regulated industry
Process owners or functional leaders wanting to improve their processes
Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Internal Auditors and Managers
Training Specialists
CAPA Specialists
Designated Management Representatives
Quality/Compliance managers or directors for Medical Device companies
General Managers wanting to learn about understand Quality System requirements
Subject Matter Experts who write procedures

Last modified: 2021-08-02 21:27:05