America's Top Tradeshow Directory | Events In America
Facebook Linked In Twitter Videos

Paid membership required to see this information

This interactive one-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 must update their systems and processes to maintain compliance.

This seminar will help you understand the specific requirements associated with local and SaaS/cloud hosting solutions. Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.

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.

Learning Objectives:

  • 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
  • Protect intellectual property and keep electronic records safe

Who Will Benefit:

This course will benefit all who use 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

Note:
Use coupon code NB5SQH8N and get 10% off on registration.

Don't wait to register for the 21 CFR Part 11/Annex 11 Compliance For Software Validation And SaaS: In-person Seminar. You'll meet influential people and maximize your opportunities for success. Start now by accessing the information below.

All information in Events In America is deemed to be accurate at the time we add it, and we take steps to verify all details and update our records when new information is provided, but as people, events and circumstances change, we caution users to independently confirm all information. EventsInAmerica.com and Events In America LLC make no guarantee of accuracy and assume no liability for inaccurate information.

Website: http://www.complianceonline.com/21-cfr-part-11-annex-11-compliance-sof...
Conference/Event Dates: 09/14/2016 - 09/14/2016
Conference/Event Hours: 8:30 AM to 4:30 PM
Classification: B2B
Primary Industry: Software
Other Industries: Software, Technology
Estimated Attendance: 30
Cost to Attend: One Registration: - $899
Audience: Regulatory Affairs
QA/ QC
IT/IS
Software Managers
Project Managers
Software vendors and suppliers
Venue: Manchester Grand Hyatt San Diego
Venue Phone: (888) 717-2436
Venue Type: Indoor - Hotel
Show Owner:ComplianceOnline

Booth Size Booth Cost   Available Amenities
Call for information.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: Call
Other Booth Sizes Available: n/a

Advance Networking

How do I show up here?
 

Personal Notes

Add a note here, it is only visible by you.

New Search Contact This Event
21 CFR Part 11/Annex 11 Compliance For Software Validation And SaaS: In-person Seminar

exhibitor lists