Understanding the new International and FDA accepted Software Development Standard IEC 62304
Instructor:
Dennis Moore
Product ID: 700318
Training Level: Advanced
- Duration: 60 Min
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.
- 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
Instructor Profile:
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts and software auditing techniques. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.
More Training By Experts
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- Key differences in Design Control Requirements between ISO13485:2003 and the FDA Quality System Regulation
- How to successfully audit software systems, and thereby avoid having FDA write software-related 483's and warning letters
- 'Performing effective supplier audits: a coming FDA compliance focus'
- Using the FDA guidance General Principles of Software Validation to strengthen your firm's software FDA compliance
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