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EVENT DATE
Sep 2016
M T W T F S S
05060708091011
EXPO DATE
Sep 2016
M T W T F S S
05060708091011

Venue

Courtyard Philadelphia Downtown 21 N. Juniper Street
Philadelphia , PA 19107
Location map
Type: Indoor - Hotel

Partners

exhibitus success by design Remington Hotels NorthStar Express Freight

Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar

Courtyard Philadelphia Downtown
B2B 30

This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. 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.

Many companies outsource IT resources and are involved in 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 to avoid FDA form 483s and Warning Letters.

This Computer System Validation Training course is intended for these regulated companies, software vendors, and SaaS/cloud providers. The seminar 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.
  • Help participants understand the specific requirements associated with local and SaaS/cloud hosting solutions.
  • Illustrate the importance of validating the quality process and every computerized system used in laboratory, clinical, and manufacturing settings.
  • Demonstrate how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation.
  • Review recent FDA inspection trends and discuss how to streamline document authoring, revision, review, and approval.

Learning Objective:

  • Understand what is expected in Part 11 and Annex 11 inspections
  • Avoid 483s 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:

This CSV Training 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.

There may be many networking opportunities at the Computer System Validation - Reduce Costs and Avoid 483s: 2-day In-person Seminar. Find out more in the event details below.

EVENT CONTACTS


Referral
ComplianceOnline
2600 E. Bayshore Road
Palo Alto, CA 94303
(888) 717-2436

EVENT DETAILS

Primary Industry:
Business Technology
Other Industries:
Business Technology, Software, Technology
Audience:
Regulatory Affairs
QA/ QC
IT/IS
Software Managers
Project Managers
Software vendors and suppliers
Notes:
Attendee Statistics:
Show Owner:
ComplianceOnline
Sponsorship:
Sponsorship Details:
http://www.seatradecruiseglobal.com/sponsorship-opportunities

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