What is 21 CFR Compliance 2018 - What is 21 CFR Compliance | 21 CFR Part 11 Regulations 2018

Validation and 21 CFR Part 11 Compliance of Computer Systems
What is 21 CFR Compliance | 21 CFR Part 11 Regulations 2018
Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.
This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools
The Seminar
This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:
1. Validation Master Plan
2. Complete Validation for a System
3. Excel Spreadsheet Validation
4. Change Control
5. SOPs
6. Test Tools Validation
7. Project Management for Validation
Who Should Attend:
• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers
Industries:
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
Agenda:
Day 1 Schedule
Lecture 1:
Introduction/Background
• Introductions / Participants' Understanding
• Participants' Objectives for the Course (Please come prepared to discuss)
Lecture 2:
Requirements at a High Level
• Types of Requirements
• Difference between User Requirements & Functional Requirements
Lecture 3:
Detailed Requirements Study
• Gathering Requirements
• Entity Relationship Diagram
• Process Decomposition
• Risk Assessment for Requirements
• Exercise on how to create Requirements
Lecture 4:
Design
• Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications
Day 2 Schedule
Lecture 5:
CSV Detailed Study (Cont'd)
• Traceability Matrix
• Verification and Testing
• Exercise Creating Validation Scripts
• Exercise Creating Traceability Matrix
Lecture 6:
Other Documents
• Validation Plan
• Test Protocols
o Test Reports
• Validation Report
• Validation Registry
Lecture 7:
Special Topics
• Project Management for CSV
• Infrastructure for CSV
• Selecting software for 21 CFR 11 Compliance
• Test Tools for CSV
Lecture 8:
Change Control & Business Continuity
• Change Control
• Implementing Business Continuity for CSV
Speaker
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58C... Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/... National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144....
Location: Boston, MA Date: March 1st & 2nd, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Four Points by Sheraton Boston Logan Airport Revere, MA 407 Squire Rd, Revere, Massachusetts 02151, United States
Price:
Register now and save $200. (Early Bird)
Price: $1,295.00 (Seminar Fee for One Delegate)
Until January 20, Early Bird Price: $1,295.00 From January 21 to February 27, Regular Price: $1,495.00
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%)*
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/spon...
Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson-AT-globalcompliancepanel.com
support-AT-globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/glob...
Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancep...
Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalComplian...
Follow us on Twitter: https://twitter.com/GCPanel