Pharmaceutical Trends for Computer Systems Regulated by FDA

The Webinar will focus on the importance of managing FDA oversight of computer system validation in the pharmaceutical industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment.  FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.

Pharmaceutical companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation.  In all cases, pharmaceutical companies should do the right thing and have robust computer system validation programs that are well executed and documented.  However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, pharmaceutical companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.

Typically, a pharmaceutical company will develop a relationship with the FDA office that sends auditors to oversee computer system validation programs in their organization. Depending on upcoming trends, pharmaceutical companies may want to work harder to further strengthen these relationships and build greater trust with FDA to ensure that even as oversight becomes more overbearing, it will not cause the company to waste resources trying to meet expectations that may be unrealistic.

A good example of a recent trend is the focus on risk management in developing, executing and documenting a validation program and validation plans for specific systems at pharmaceutical companies.  FDA has fewer resources to conduct audits and oversight of computer system validation, hence pharmaceutical companies have been expected to identify the risk associated with each computer system that “touches” product (through manufacturing, testing, distribution, etc.), and take the appropriate measures to mitigate that risk.  The trend has been for FDA to ask questions relevant to risk and ascertain fairly early during an audit what lengths the company has gone to in order to prove they have thoroughly validated their systems accordingly.

Areas Covered in the Session : 

• Describe some of the key factors that influence the degree of FDA oversight for computer system validation programs in the pharmaceutical industry
• Discuss how to anticipate and understand trends, as they begin to emerge in the pharmaceutical industry
• Discuss ways to build a solid relationship with FDA and leverage it to gather information about emerging trends
• Discuss ways that pharmaceutical companies can adjust their computer system validation programs to changes in the regulatory environment
• Discuss ways to apply basic computer system validation principles to ensure that in all cases a pharmaceutical company is prepared for emerging trends
• Provide examples of changes to the factors influencing the regulatory environment and how pharmaceutical companies have reacted or responded
• Discuss some of the unnecessary risks pharmaceutical companies have taken in response to changes in the regulatory environment and the ramifications
• Interactive Q&A Session

Who Should Attend:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco.  Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.  Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. 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. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.