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.
- 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
- 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
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
- Risk Management
- Regulatory Compliances
- Corporate Governance
- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...