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Compliance Global Inc
2754 80th Avenue
New Hyde Park, NY 11040
(516) 900-5515

Event Description

Overview:

Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Why Should You Attend:

You should attend this webinar training on computer system validation regulated by FDA, if you are responsible for planning, executing or managing the validation of a system. This is true whether using a "wet" or ink-based signature, or an electronic signature. It is also true whether maintaining paper-based or electronic records. Different requirements pertain to each type of signature or record, and there is a specific set of best practices that need to be followed for either type.

Areas Covered in this Webinar:

  • Learn the requirements for documenting efforts related to systems governed by FDA
  • Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
  • Review examples of incorrect, incomplete, or otherwise inappropriate and non-compliant documentation and understand why these are not acceptable

Learning Objectives:

  • Get an understanding of computer system validation planning, execution and management concepts, in terms of how these efforts are to be adequately documented to meet FDA requirements
  • Understand the steps required for documenting the validation process, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs

Who Will Benefit:

  • Information Technology Analysts
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Compliance Managers
  • Lab Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders 
  • Consultants in the Life Sciences Industry

Speaker Profile:

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.
For more detail please click on this below link:

http://bit.ly/1U8YlAW

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

If the Good Documentation Practices to Support FDA Computer System Validation - By Compliance Global Inc. is important to your business, act now and make the appropriate connections. See the contact information below.

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Event Details

Website: http://bit.ly/1U8YlAW...
Conference/Event Dates: 06/21/2016 - 06/21/2016
Conference/Event Hours: 1:00
Classification: B2B
Primary Industry: Clinical Pharmacology
Other Industries: Clinical Pharmacology, Professional Healthcare
Cost to Attend: Live Session for one participant Price: $175.00
Audience: Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Analytical Chemists
Compliance Managers
Lab Managers
Automation Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders
Consultants in the Life Sciences Industry
Show Owner:Compliance Global Inc.
Sponsorship: Yes
Sponsorship Details: Compliance Global Inc.

Booth Details

Booth Size Booth Cost   Available Amenities
No exhibiting.   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

Advance Networking

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Mark Travers

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