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Contract Management for Vendors of FDA-Regulated Systems

This course provides guidelines for coaching attendees on best practices for managing vendors, consultants, contractors involved dealing with computer systems.

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Contract Management for Vendors of FDA-Regulated Systems

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  1. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  2. Instructor Profile: Carolyn Troiano has more than 25 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently the ERP (Enterprise Resource Planning) Program Manager at the City of Richmond, VA, where she is overseeing the implementation of a large, complex system that spans more than 40 agencies and is used by more than 4,000 City employees.Prior to working for the City, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. Carolyn was responsible for computer system validation across all regulated functions at Wyeth Laboratories, now part of Pfizer. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject. While at Wyeth, Carolyn co-authored 21 CFR Part 11, or the FDA’s electronic record/electronic signature (ER/ES) regulation as part of an FDA/Industry partnership. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  3. Why Should you Attend: The attendee will learn how to develop a standard approach to managing vendors who provide products and services, consultants and contractors in a manner that complies with FDA guidelines for computer systems. Some of these people will be new to the concept of validation and FDA regulation, and will have to be coached on how to follow any necessary procedures required for compliance. This is true for vendors who engage companies in the Tobacco industry, where regulations are emerging, but it is also true in pharmaceutical and related industries where vendors are new to this market and may not have the skills or training required. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.  There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective techniques and tools available to assure compliance when managing vendor-related activities.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  4. Who can Benefit: Information technology analysts, project managers, organizational change managers, business process engineers, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GxP training specialists, business stakeholdersand individuals who are responsible for computer system validation planning, execution, testing, reporting, compliance, and audit. This webinar will also benefit any consultants, contractors or vendors providing products and services to the life sciences industries and who are involved in computer system implementation, validation and compliance.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  5. Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdf format will be mailed to you • Login to the session using the username and password provided to you • Get answer to your queries through interactive Q&A sessions via chat • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve • Get certification of attendance. Recorded Session - How it works • A link will be provided to you upon purchase of the recorded session • Please click on the link to access the session • Presentation handouts in pdfformat will be mailed to you • Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

  6. Reach us on : www.onlinecompliancepanel.com Our links www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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