21 CFR Part 11 Compliance Checklist 2018 is going to be between 14 Mar and 15 Mar 2018.
The Course venue is Hilton Zurich Airport in Zurich, Switzerland.
You possess the opportunity to get the most popular progresses in Software Validation, Computer Systems and Medical Devices at this significant Course.
21 CFR Part 11 compliance for software validation and SaaS/Cloud is three times a year Course.
The professional congress organizer of the 21 CFR Part 11 Compliance Checklist 2018, 21 CFR Part 11 compliance for software validation and SaaS/Cloud is Global Compliance Panel.
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This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies
- Understand what is expected in Part 11 and Annex 11 inspections
- Avoid 483 and Warning Letters
- Learn how to buy COTS software and qualify vendors.
- Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
- Requirements for local, SaaS, and cloud hosting
- How to select resources and manage validation projects
- "Right size" change control methods that allows quick and safe system evolution
- Minimize the validation documentation to reduce costs without increasing regulatory or business risk
- Write test cases that trace to elements of risk management
- Protect intellectual property and keep electronic records safe
- Who will benefit:
- QA, IT, management
- all GxP system users
Hilton Zurich Airport
Address : Hohenbühlstrasse 10, 8152 Opfikon, Switzerland