This course is intended to help the developing Medical Technology (MedTech), Biotechnology (Biotech) and Health Technology (Health Tech) industry. Trainees will learn about Quality and evolution of Quality Management Systems (QMS), then what a QMS is, what it covers and why a QMS is key for organisations to achieve commercial success.

Topics

1. Introduction
2. Overview of Quality
3. Overview of Quality Management Systems (QMS)
4. International Standards Organisation (ISO) Introduction
5. ISO 9001 (QMS Standard for any sized organisation in any industry)
6. ISO 13485 (QMS Standard for medical device organisations)
7. Corrective Action and Preventive Action (CAPA) is central to a QMS
8. Conclusion

Participants

The target audience for this course is personnel new to QMS requirements You may be a:

• Student
• Researcher with plans commercialise a product
• Start-up organisation preparing for commercial success
• Growing company with plans to align with or obtain certification to ISO 9001 or 13485
• New starter in an organisation with a QMS or new to the regulated medical device industry

Assessment / Certificate

As a free course, there is no assessment or certificate.

Duration

The course is expected to take less than 2 hours.

Your licence grants you access to the course for 30 days.

SeerPharma uses information you provide to contact you about our products and services. You may unsubscribe from these communications at any time. See our Privacy Policy.