Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

  • 1295.00 Dollar US$
  • Published date: July 14, 2017
    • Baltimore, MD, Baltimore, MD, United States

Course "Validation of Computer Systems for Production and Quality and Software Embedded Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Why should you attend:

• Understand Verification and Validation, differences and how they work together
• Develop a "Working Definition" of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• Software Verification & Validation requirements of the FDA and ISO.
• The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
• Device and Manufacturing software requirements for V & V
• How to determine & demonstrate an appropriate V & V strategy
• How to determine & handle software for different Levels of Concern
• What V&V is required for 3rd Party software-custom and Off-the-shelf
• Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
• What to look for during software vendor audits.
• V & V documentation and level of detail required for device submissions.
• How to document a "risk-based" rationale, and use it in a resource-constrained environment
• Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
• Generate Master and Individual Validation Plans
• Learn the key elements of a Product V&V protocol and expectations with the Summary Report
• Develop Process and/or Production/Test Equipment V&V Files/Protocols
• Sample sizes and their justification
• Learn the key elements of Software V&V expected by the FDA and how to document appropriately and adequately
• QMS Electronic Records and Electronic Signatures per 21 CFR 11
• Regulatory Requirements for Software Validation and Benefits
• Quality System Regulation vs Pre-Market Submissions
• Software requirements in specifications
• Verification and Validation process
• IQ/OQ/PQ in software V&V and next steps for compliance
• Software development as part of system Design
• Software life cycle verification
• Software validation after a change
• Validation of Off-the-Shelf Software and Automated Equipment
• What is Process Validation
• What are FDA and international requirements for Process Validation
• Process Validation & Equipment Qualification
• Examples of successful Process Validation activities
• Where and how does software validation integrate into the Validation Plan


Location: Baltimore, MD Date: September 21st & 22th, 2017 and Time: 9:00 AM to 6:00 PM
Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090 USA
Price:

Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900974SEMINAR?science-marketplace-September-2017-SEO
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