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Sunday, April 8 • 8:00am - 5:00pm
Workshop 4 - CSV 101: Basic Concepts in Computer Validation (2 days)

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RQAP re-registration units: 4 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Objectives
At the end of the course, the participants shall be able to: 
  • Provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
  • Address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
  • Be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Agenda
  • Understanding the Regulations and Guidelines.
  • Identifying the Components of the System Life Cycle.
  • In-depth look at the Validation Deliverable.
  • Planning, Conducting and Documenting the Computer Validation Audit.

Speakers
avatar for Helene Andersson

Helene Andersson

Quality Assurance Manager, Toxikon Corporation
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Frank Moschetto

Frank Moschetto

Propietor/Principal Consultant, Frank M Consulting LLC
Mr. Moschetto has worked in the pharmaceutical industry for over 30 years, in research and development primarily in a GLP/GCP environment, and has performed inspections of Computer System Validations, and Data Centers & Host (Cloud) facilities in preparation for several SaaS (Software... Read More →
avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →

Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 7
  QC Workshop, QC Workshop - 2 Day

Attendees (6)