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FDA 21 CFR Part 11 Compliance - Validation Seminar 2018

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SEMINAR?May-2018-seo-pharmiweb

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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

Details

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

Speaker

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley 

 

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. 

Location:  Germany Date: May 3rd & 4th, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,790.00 (40%)*

 Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $8,528.00 (45%)*

Register now and save $200. (Early Bird)

Until March 31, Early Bird Price: $1,695.00 From April 01 to May 01, Regular Price: $1,895.00

 Sponsorship Program benefits for “FDA 21 CFR Part 11 Compliance - Validation Seminar 2018” seminar

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 - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901447SEMINAR?SEO

 

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Prices

Price: $1,695.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,790.00 (40%)* Register for 10 attendees Price: $9,322.00 $16,950.00 You Save: $8,528.00 (45%)* Register now and save $200. (Early Bird) Until March 31, Early Bird Price: $1,695.00 From April 01 to May 01, Regular Price: $1,895.00

Contact

Roger Steven
support@mentorhealth.com

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