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Course "21 CFR Part 11 compliance for software validation and SaaS/Cloud" has been pre-approved by
RAPSas eligible for up to12credits towards a participant's RAC recertification upon full completion.Overview:
Agenda:
Lecture 1:
Introduction to the FDA
Lecture 2:
21 CFR Part 11/Annex 11 - Compliance for Electronic Records and Signatures
Lecture 3:
The Five Keys to COTS Computer System Validation
Lecture 1:
Ten-Step Process for COTS Risk-Based Computer System Validation
Lecture 2:
How to Write Requirements and Specifications
Lecture 3:
How to Conduct a Hazard Analysis/Risk Assessment-Exercise
Lecture 4:
Software Testing
Lecture 5:
System Change Control
Lecture 6:
Purchasing COTS Software
Lecture 7:
Cost Reduction Without Increasing Regulatory or Business Risk
Speaker
FDA Compliance Specialist,
Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.
David Nettleton is also the co-author of:
Location:Zurich, SwitzerlandDate: October 12th & 13th, 2017 and Time: 8:30 AM to 5:00 PM
Venue: Hilton Zurich AirportHohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50
Price:
Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until August 31, Early Bird Price: $1,695.00 From September 01 to October 10, Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00 $8475.00 You Save: $3,390.00 (40%)*
Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $7,628.00 (45%)*
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
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Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900924SEMINAR?ticketforevent-October-2017-SEO
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GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.