Falls Church, VA (PRWEB) November 30, 2016
A couple of QSR violations cited in 483s and warning letters get all the attention: CAPA, design control, process validation and complaint files.
But the 59 words in Sec. 820.70 Production and process controls (i) Automated processes are causing increasing trouble for devicemakers.
QSR and ISO 13485:2016 provide the framework for compliance — they tell manufacturers what the requirements are. What they don’t tell is how to comply. They’re silent on the best practices for validating ERP, COTS or home-grown software-based systems.
The keys to validating and revalidating as necessary the software that drives automated processes are found in a variety of obscure standards and guidances:
- AAMI TIR36:2007, Validation of software for regulated processes
- FDA guidance, General Principles of Software Validation, January 11, 2002
- FDA guidance, Medical Device Quality Systems Manual: A Small Entity Compliance Guide, December 1996, Chapter 7
- FDA guidance, Blood Establishment Computer System Validation in the User’s Facility, April 2013 (while not specific to devices, this widely overlooked guidance provides some of the best validation tools that devicemakers can also use)
Join industry expert, Dan O’Leary on Dec. 14 when he’ll significantly push beyond the surface and provide proven techniques for validating the software used daily as part of the production and process controls.
After this 90-minute webinar attendees will:
- Understand how and why the FDA is focused on this emerging threat area
- Identify the systems that need validation and revalidation
- Discuss the overlooked — practically ignored — standards and guidances that are the difference between a clean inspection and a warning letter
- Be confident that major elements necessary are included in an effective SOP for software validation
- Understand why software validation and revalidation needs to be proportionate to the risk associated with the use of the software
- Become an expert in writing validation planning docs and reports
- Understand the application and benefits of black box and white box testing strategies
- Explore the two new software validation areas in ISO 13485:2016 and their impact on P&PC operations
- Receive a refresher on the requirements in QSR, ISO 13485:2003 and ISO 13485:2016
Bonus Material: Webinar participants receive a proven checklist that provides all the specific things manufacturers need to do to protect themselves from a warning letter.
Register today for the tools needed to assure compliance when the FDA knocks on the door.
Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 year’s experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit:
- Production Managers
- Production Supervisors
- Manufacturing Engineering Managers
- Manufacturing Engineers
- Quality Managers
- Quality Engineers
- Reliability Engineers
- Maintenance Managers
- Maintenance Supervisors
Validating the Software That Powers Your
Manufacturing Systems and Automated Processes
**An FDAnews Webinar**
Dec. 14, 2016 — 1:00 p.m. – 3:00 p.m. ET
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.