FDA Seminar, Houston, Texas Validation and 21 CFR 11 Compliance of Computer Systems Nov 5-6, 2015
Thursday, Nov 5- Friday, Nov 6, 2015 at Houston, Texas FDA Regulated Executives will have the opportunity to discuss the latest practices and regulations in Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry . This conference will offer a wide array of discussion topics on both a national and international scale, opportunities for networking, and small group workshops for idea sharing.
Houston, TX, September 09, 2015 --(PR.com)-- The course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, & High Tea/Coffee provided by WCS.
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.
Seminar One Registration $999 Regular Price $1499
05-06 November Houston Texas
Learning Objective:
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
Faculty
WCS experts comes from all corners of the FDA Regulated industries will be onsite to lead presentations, case studies, workshops and panel discussions with Angela Bazigos who is the Chief Compliance Officer of Morf Media. She comes with 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices and 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring 4to the Boardroom.
World Compliance Seminars provides innovative Continuous Professional Education and e-learning solutions and Consulting. Our clients range from SME's to Fortune 500 companies. Our training services set new benchmarks, as a result of which our customers get custom cost-effective, on-demand training solutions from us.
Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, & High Tea/Coffee provided by WCS.
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.
Seminar One Registration $999 Regular Price $1499
05-06 November Houston Texas
Learning Objective:
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
Faculty
WCS experts comes from all corners of the FDA Regulated industries will be onsite to lead presentations, case studies, workshops and panel discussions with Angela Bazigos who is the Chief Compliance Officer of Morf Media. She comes with 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices and 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring 4to the Boardroom.
World Compliance Seminars provides innovative Continuous Professional Education and e-learning solutions and Consulting. Our clients range from SME's to Fortune 500 companies. Our training services set new benchmarks, as a result of which our customers get custom cost-effective, on-demand training solutions from us.
Contact
World Compliance Seminars
John Ryan
347-282-5400
https://www.worldcomplianceseminars.com
John Ryan
347-282-5400
https://www.worldcomplianceseminars.com
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