Live webinar Medical Device Industry Trends for Computer Systems Regulated by FDA

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms. "

The Webinar will focus on the importance of managing FDA oversight of computer system validation


The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies.  Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process.  When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state.

Why should you attend :

The Webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device 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.
Medical device 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, 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, 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 medical device 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, medical device 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.

Areas Covered

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

Who will Benefit

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• 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 tobacco or life science industries who are involved in computer system implementation, validation and compliance.

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Carolyn Troiano

Carolyn 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

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