An efficient and effective Quality Management System is the cornerstone for organizations in the regulated industries. Such a QMS signals to the regulatory authorities such as the FDA and others, that there are no lacunae in the completeness, accuracy, and consistency of an organization’s QMS.
It is not to satisfy the regulatory bodies alone that a robust QMS is necessary: it also gives the organization’s personnel the ability to meet quality requirements with consistency and accuracy. Accuracy of outcomes and quality of work are the results of such an assurance.
It is to help organizations in the regulated industries understand and get their QMS right, in the prescribed manner, that GlobalCompliancePanel, a leading provider of professional training for all the areas of regulatory compliance, is organizing a long, six-hour webinar, on Jan 21, 2020.
GlobalCompliancePanel brings Susanne Manz, a well-known and highly accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, as the Director of this web seminar. To register for this highly valuable learning, please log on to GlobalCompliancePanel
The regulatory guidelines state that the organization should “…establish and maintain a quality system that is appropriate for the specific medical device(s) designed and manufactured”. This makes it imperative for organizations to understand the exact requirements relevant to them and tailor them to their precise needs.
The consequences of having an inefficient QMS are obvious:
- It can lead to serious compliance and quality issues, inviting 483 observations, Warning Letters, and even consent decrees
- It can lead to inconsistent or poor product quality, which could result in non-conformances, complaints, and even recalls
- The confusion and inconsistency it generates could lead to duplication of work and corrective and preventive actions, all of which can drastically increase the cost of quality
It goes without saying that utterly squandered time and money, and missed opportunities are the fruit of all this.
This marathon session will help participants understand the gravity of these issues and teach them how to avoid getting into these troubles, which can eventually destroy the business.
At this session, Susanne will explain the fundamentals of a sound QMS. She will show how to put in place an efficient and effective QMS with which the organization can meet its compliance objectives and improve its product quality, which brings in higher customer satisfaction and vastly enhanced business outcomes.
Core aspects of how to establish and maintain a QMS will be explained. These include the Basic Requirements, Management Responsibility, Quality Audit, Personnel, QMS structure, Quality Policy, Quality Manual and Standard Operating Procedures, Work Instructions, Forms, etc.
Participants will gain the following learning objectives at this session:
- 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
This webinar has the following agenda:
- Regulatory Expectations
- Lessons Learned from 483s and Warning Letters
- Common Problems, Mistakes, and Warning Signs
- How to Structure your QMS
- Quality Policy and Manual Requirements
- QMS Structure, Hierarchy, and Documents
- Roles and Responsibilities
- Key capabilities
- Best Practices
- Vision, Strategy, and Planning
About the expert: Black Belt, Master Black Belt, Regulatory Affairs Certification (RAC) and Certified Quality Auditor (CQA) Susanne Manz brings an extensive background in quality and compliance for medical devices, which spans all areas from new product development, to operations, to post-market activities. Her consulting business provides services to help medical device companies achieve world-class quality and compliance.