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Data Integrity, 21 CFR 11 & Annex 11 Implementation 2020
Date
Dec 09, 2020 - 09:00 AM
- Dec 10, 09:00 AM
Link to Website
Organizer
Lanie
Venue
Hilton San Francisco Airport Bayfront
Location
600,
Airport Blvd
Burlingame,
CA,
USA,
ZIP: 94010
Phone:
Course "Data Integrity, 21 CFR 11 & Annex 11 Implementation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
The Problem:
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems
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:
Who Should Attend:
Agenda:
Day 1 Schedule
Lecture 1:
Introduction / Background
Data Integrity
21 CFR 11 & Annex 11
Risk Assessment & Requirements
Day 2 Schedule
Lecture 1:
Design
Verification & Testing
Special Topics
Change Control & SOPs
Speaker
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. The 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/4FA562336EBD46C58CDC43A8B7773095.ashx 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/2020/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborate 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.7144112.html#overview.
Location: SFO, CA Date: December 7th & 8th, 2020 and Time: 9:00 AM to 6:00 PM
Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010, USA
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 in 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
[email protected]
[email protected]
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=901052SEMINAR?eventbrite-December-2020-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
LAN171117CEV
Overview:
The Problem:
We have all heard of Data Integrity but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
- Evolution of 21 CFR Part 11 and Annex 11 and Why they are Back in the News
- Overview and Key Requirements of Part 11 & Annex 11
- How to use a Risk-Based Assessment to reduce work while still achieving Data Integrity and Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
This course is appropriate for beginner and experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems
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:
- What is Data Integrity and how is it implemented
- How to use Risk-Based Assessments to reduce work while still achieving Data Integrity and Compliance?
- Data Integrity Frequently Asked Questions
- Validation Master Plan
- Risk-Based Assessment
- Complete Validation for a System (software development lifecycle)
- Automated Test Tools
- Infrastructure Requirements
- Change Control
- SOPs
Who Should Attend:
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for DATA INTEGRITY / 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
- Consultants
- Data Managers
- Safety Managers
Agenda:
Day 1 Schedule
Lecture 1:
Introduction / Background
- Introductions / Participants' Understanding
- Participants' Objectives for the Course (Please come prepared to discuss)
Data Integrity
- What is Data Integrity
- How is it implemented
- Data Integrity Frequently Asked Questions
21 CFR 11 & Annex 11
- 21 CFR 11
- Annex 11
- 21 CFR 11.10(a) - Computer Systems Validation
Risk Assessment & Requirements
- Risk Assessment for Requirements
- Gathering Requirements
- Entity Relationship Diagram
- Process Decomposition
- Exercise on how to create Requirements
Day 2 Schedule
Lecture 1:
Design
- Design Specifications
- Software Configuration and Build
- Exercise on how to create Design Specifications
Verification & Testing
- Traceability Matrix
- Verification and Testing
- Other Documents
Special Topics
- Test Tools for DATA INTEGRITY
- Infrastructure Requirements
Change Control & SOPs
- Change Control
- SOPs
Speaker
Angela Bazigos
CEO, Touchstone Technologies Silicon ValleySeasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. The 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/4FA562336EBD46C58CDC43A8B7773095.ashx 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/2020/07/24/using-training-to-bring-compliance-to-boardrooms/ National Trainer for Society of Quality Assurance. Comments / collaborate 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.7144112.html#overview.
Location: SFO, CA Date: December 7th & 8th, 2020 and Time: 9:00 AM to 6:00 PM
Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010, USA
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 in 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
[email protected]
[email protected]
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=901052SEMINAR?eventbrite-December-2020-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
LAN171117CEV
Event Categories
COMPUTERS AND INTERNET CONFERENCES
, Technology
Keywords: administration , assessment , Book , business , class , Clinical , conference , design , development , Engineering