April 27-29 , May 18-20 and June 21-23, 2021
12:30 PM -05:00 PM EST | 09:30 AM - 02:00 PM PST
3-Day Virtual Seminar
This session will be held via Video Conference over three successive daysCourse Description
Boot camp is tough and challenging. It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises and case studies keeps energy levels high and challenges the participants.Participant Testimonials
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterwards about it. Thank you WCS for bringing on board such wonderful experts.
Robert Friedland , IT Manager NUTEK BRAVO, LLC.
For me the training was useful in order to clarify requirements from the FDA in regards to the expectation for the Computerised System Validation process. I will definitely recommend this course to others.
Yorlehin Robiou , Quality Systems and Compliance Manager, Jabil HealthcareWho Should Attend
What should be done if there is no audit trial capability for a system?
Faculty Answer If there is no audit trial capability for a system then that does not get you off the hook with FDA.You have to produce some evidence that you know what changes you can make where you show objectively the entire history of the record.Registration Cost Includes:
Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.Hands-On Training
A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection– ready validation projects.AGENDA - Day 1Module 1: Regulation for CSV
Understanding of how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11
The purpose of each validation deliverable and hands-on practice creating each deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report
Comprehension of risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches
Appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom developed systems
Awareness of best-practices and inspector expectations for computer system validation and software quality assurance (SQA) programsWhy Should You Attend:
We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies.
We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.For Registration Click Below Link
Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.
My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.
My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.