Best practices in Quality Management System and management controls needed to meet US FDA and ISO 13485 requirements This pack of two training courses provides 2 hours of training on basic requirements and best practices of quality management system for non-Regulatory and Quality Assurance experts in the medical devices industry as well as principles and practices needed to effectively develop and implement the Management Controls necessary to ensure an effective Quality Management System (QMS) and to comply with the requirements of the FDA QS Regulation
- Module 1: Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
- Participants will become familiar with the governing requirements for management controls by understanding the responsibilities that executive management is obligated to meet and the challenges executive management faces in meeting QMS and FDA QS requirements.
- What Attendees will Learn:
- Importance of Management Controls, Legal obligations, Commitment, Management Controls (quality planning, quality policy, quality objectives, management representative, management review, human resources, training), Challenges for your company, Meeting those challenges.
Course Provider
Susan C Reilly,
