ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices. This 6 -hour virtual seminar will help you to understand the process approach and develop an effective 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 System Processes
- Process Ownership, Management, and Control
- Roles and Responsibilities
- QMS structure
- Standard Operating Procedures, Work Instructions, Forms, etc.
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. It ensures that processes are well defined, managed, and controlled yielding predictable and acceptable results. A controlled quality management system avoids unpleasant surprises and resulting rework, delay, and cost.
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 incorporate a process approach to 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
- Establishing QMS processes
- A Process Approach
- Process Ownership, Management, and Control
- Maturity modeling
- Improvement tools
- Best practices
- Preparing for an FDA inspection
Agenda
1. Regulatory expectations
2. Lessons Learned from 483s and warning letters
3. Common problems, mistakes, and warning signs
4. A Process Approach
5. Roles and Responsibilities
6. How to structure your QMS
7. Quality policy and manual requirements
8. QMS structure, hierarchy, and documents
9. Turing processes into well-written SOPs
10. Key capabilities
11. Best practices
Speakers
Susanne Manz,
President and Principal Consultant ,
Manz Consulting, Inc.Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Who Should Attend
- 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 understand Quality System Requirements
