Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA - Recorded Webinar

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Carolyn Troiano

OVERVIEW:
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.

Disaster recovery activities often include efforts to deal with both system functionality and data integrity, quality, accessibility and accuracy. Business continuity activities often include efforts to deal with system functionality and data integrity, quality, accessibility and accuracy, but the focus is on getting the business processes running in the absence of a sound system or data.

The specific tasks and deliverables for both disaster recovery and business continuity must be completed with care toward maintaining a compliant environment. 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.

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. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.

The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of day-to-day business operations 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. It's important to look at what are some of the threats and challenges, and what methods you can use to mitigate these.

Areas Covered in the Session:
- Gain an understanding of disaster recovery and business continuity planning
- Develop the ability to apply FDA compliance requirements when developing a disaster recovery and business continuity plan
- Understand the best practices for developing a disaster recovery and business continuity plan
- Discuss the best practices necessary to ensure all systems regulated by FDA are protected against disaster and are recoverable in the event disaster strikes
- Discuss the best practices necessary to ensure all critical business operations can continue uninterrupted, should a disaster occur that causes key systems to become inoperable or inaccessible
- Understand the importance of preparing documentation that is compliant with FDA requirements
- Learn about the importance of training, as part of preparation
- Q&A

Who Will Benefit:
- Information Technology Analysts
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers
- Lab Analysts and Managers
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders and Individuals who are responsible for Computer System Validation Planning, Execution, Reporting, Compliance, Maintenance and Audit
- Consultants working in the Life Sciences Industry who are involved in Computer System Implementation, Validation and Compliance

SPEAKER PROFILE:
Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.
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