21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-day In-person Seminar

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Category 21 CFR Part 11 Compliance;

Deadline: December 04, 2014 | Date: December 05, 2014-December 06, 2014

Venue/Country: San Francisco, U.S.A

Updated: 2014-12-02 21:46:53 (GMT+9)

Call For Papers - CFP

Significant changes in the regulations and industry standards for software validation are detailed in this interactive two-day course. The instructor will address the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation related to FDA 21 CFR Part 11, European Annex 11, and HIPAA electronic security regulations for patient medical records.

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 must update their systems and processes to maintain compliance.

Course Objectives:

Understand what is expected in Part 11 and Annex 11 inspections

Avoid 483 and Warning Letters

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

Who will Benefit:

This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.

Regulatory Affairs

QA/ QC

IT/IS

Software Managers

Project Managers

Software vendors and suppliers

Use coupon code 232082 and get 10% off on registration.