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

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Category HEALTHCARE TRAINING 2021

Deadline: September 29, 2021 | Date: September 29, 2021

Venue/Country: Online event, U.S.A

Updated: 2021-08-02 21:43:01 (GMT+9)

Call For Papers - CFP

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

Personnel

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