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

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

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Who should attend?

Regulatory Affairs Management Regulatory Affairs Specialist Auditors Compliance Quality Assurance Management Engineering/Technical Services Operations/Manufacturing Consultants Quality Assurance or Quality Control Professionals IT/IS R&D Production Management Manufacturing Engineers Process Engineers Software Engineers Validation Engineers Project Managers Hardware and software vendors, sa

Details

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
Recent examples of FDA Warning Letter cites and other enforcement actions for non-compliant V&V findings...what went wrong
Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion
Review and discuss pain points, challenges and solutions
Guidance for Industry, Trends and FDA Inspection & Enforcement Statistics and Trends
Prepare for Regulatory Inspections, including FDA and Operate in a State of Readiness

 

Who will benefit:

 

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product development, regulatory submissions, initiating/overseeing company-wide V&V planning, using a risk-justified approach and responsible for some of the areas identified herein, certainly will benefit. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the V&V process with product, process, software and impact on the QMS from start to finish, with key emphasis on regulatory compliance and governance, including:

Regulatory Affairs Management
Regulatory Affairs Specialist
Auditors
Compliance
Quality Assurance Management
Engineering/Technical Services
Operations/Manufacturing
Consultants
Quality Assurance or Quality Control Professionals
IT/IS
R&D
Production Management
Manufacturing Engineers
Process Engineers
Software Engineers
Validation Engineers
Project Managers
Hardware and software vendors, sales and marketing

 

 

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?pharmiweb-September-2017-SEO

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

Prices

Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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