Disaster Recovery Best Practices for an FDA-Regulated Enviro

1. Disaster Recovery Best Practices for an FDA-Regulated Environment www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. Instructor Profile: Carolyn Troianohas 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. Description: This course is intended to provide specific guidelines for coaching attendees on the best practices for disaster recovery of systems and data, including the handling of documentation. Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries. There are best practices used in the FDA-regulated arena, and these can be leveraged to develop a standard and consistent approach within a company.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Why Should you Attend: The attendee will learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of systems and data in a manner that complies with FDA guidelines. Some people may 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 often true for IT staff, and is likely to be the case in companies in the Tobacco industry, where regulations are emerging. 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 activities related to handling data. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Objectives of the Presentation: The course will focus on the key aspects of disaster recovery efforts, including best practices and principles for handling this type of project work in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various aspects of system and data related projects, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance. FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how participants in projects should be managed.  www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. 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 stakeholders and 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

7. Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdf formate 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 pdf formate will be mailed to you • Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

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