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Friday, April 13 • 8:00am - 12:00pm
Workshop 23 - CSV 204: SEND-Implementation and Validation (1/2 day)

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RQAP re-registration units: 2 non-GCP, non-GLP

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

The deadline for implementation of the FDA SEND initiative is a little over a year away and many are feeling the pressure to implement and validate a SEND solution. This course will cover the process flow for harmonization, implementation and validation of a SEND solution, including the regulatory requirements covering a SEND compliant submission and potential pitfalls that may be encountered along the way. Emphasis will be placed on points to consider when meeting the expectations of SEND and workshops will allow for open discussion of issues brought forward by attendees.

At the end of the course, the participants shall be able to: 
  • Define the regulatory requirements covering a SEND submission.
  • List the elements of a compliant SEND submission.
  • Identify potential pitfalls in the implementation of a SEND solution.
  • Access the tools available for validation of a SEND solution.

Target Audience
Any individual who is embarking on the process of implementing and validating a SEND solution.

  • 1. Introduction
  • 1.a. Data processing and data integrity
  • 2. Current status
  • 2.a. Study types included
  • 2.b. Deadlines for implementation
  • 3. Regulatory expectations
  • 4. What is a SEND compliant submission?
  • 4.a. Required data sets
  • 4.b. Standard terminology
  • 4.c. Define file
  • 5. Harmonization
  • 5.a. Activities required to prepare for implementation of SEND
  • 5.b. Data systems (electronic, paper-based, etc.)
  • 6. Validation
  • 6.a. Responsibilities
  • 6.b. Points to Consider
  • 7. Potential pitfalls
  • 7.a. Risk management
  • 7.b Legacy systems
  • 7.c. Resource commitment
  • 8. Summary

avatar for Vince D'Angelo

Vince D'Angelo

VP Global QA, Instem
Vince D’Angelo FRQA has worked in the pharmaceutical software industry for over 30 years, including over 20 years’ experience in Computer Systems Validation and is currently VP Global Quality Assurance at Instem plc, who provide pre-clinical and clinical software solutions as... Read More →
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 Joanne Tyas

Joanne Tyas

Director Quality Assurance, ITR Laboratories Canada Inc.
Joanne Tyas is the Director of Quality Assurance at ITR Laboratories, a pre-clinical contract research organization in Canada. She has over 22 years of experience of working in a GLP environment. Throughout her career Joanne has worked on multiple computer validation projects and... Read More →

Friday April 13, 2018 8:00am - 12:00pm PDT
Platinum 8

Attendees (7)