This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.
Why Should You Attend:
Many firms feel that they are unsuccessful in their auditing of their software systems, and often find FDA or other auditing organizations repeatedly write them up for GMP violations. Repeated FDA 483's can lead to warning letters, seizures or even jail time. This presentation will cover the new FDA/IEC software development standard IEC 62304. We will address key process elements of the standard. Insight will be given into how FDA field staff will view your software development as it transitions to the IEC 62304 standard. Insight will also be given in terms of compliance risks to the company as it implements the standard.Learning Objectives:
- Learn key elements of the new FDA/IEC software development standard IEC 62304.
- Learn about software development process and the IEC 62304 standard.
- Learn what constitutes adequate compliance to the standard.
- How IEC 62304 integrates RMA and CAPA issues.
- How risk management fits into IEC 62304.
- How to incorporate the IEC 62394 standard into their quality system.
Areas Covered in the Seminar:
- Introduction.
- 62304 standard transition tools.
- Major FDA 483 points related to software compliance, and how firms may answer these objections.
- Trends in FDA software warning letters as firms implement the standard.
- Determining best practice for implementation.
- How to train software engineers to the standard.
- How IEC 62394 can prevent FDA 483 point issuance.
- Questions & Answers.
Who Will Benefit:
The following individuals or disciplines will benefit from attending this Webinar:- Senior executives of pharmaceutical and device firms
- Quality Unit Vice Presidents, Directors and Managers
- Vice presidents, Directors and Managers of operations
- Quality engineers and field auditors
- Regulatory and Compliance Management
- Consultants
- Quality System Auditors
Course Provider
Dennis Moore,
