With more than 35 years of IT/Business experience, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries to help the organization to a new level of operation! and her 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.
Carolyn's role has often been that of a liaison between technical and business staff, translating business needs into people, process and technical solutions, and developing ROI and risk models used to support funding.
I completed an MBA degree from Rutgers University with emphasis on Organizational Development and Marketing, and have extensive training and experience in leadership, project management, compliance, marketing, diversity, change management, and mentoring. These skills have enabled me to manage and partner with a broad range of individuals at a variety of levels in a wide range of organizational cultures.
With Carolyn's creativity, insight and tenacity, along with excellent communication and analytical problem-solving skills, She can help raise your organization to a new level!
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.
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 the preparation
Why should you attend:
The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve the 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. 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.
Who Will Benefit:
Information Technology Analysts
Information Technology Developers and Testers
QC/QA Managers and Analysts
Computer System Validation Specialists
GMP Training Specialists
Business Stakeholders/Subject Matter Experts
Business System/Application Testers
Clinical Data Managers and Scientists
Quality Managers, Chemists and Microbiologists
Regulatory Affairs Personnel
Consultants in the Life Sciences and Tobacco Industries