Webinar By ComplianzWorld 2014 - Trends in FDA regulatory oversight of computer systems in the medical device industry

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.
Course Objective:
Effective and compliant computer system validation is critical to any medical device organization. With changes in the economic, political and business factors that influence the extent to which FDA exercises oversight, companies must actively anticipate what that means for their existing and planned computer system validation programs and plans.
Course Outline:
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.
Target Audience:
Information technology analysts, QC/QA managers and analysts, clinical managers and scientists, Analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit in the medical device industry. This webinar will also benefit any consultants working in the medical device industry who are involved in computer system implementation, validation and compliance.
Price List:
Live : $199.00
Group : $799.00
Recorded : $249.00
Training CD-DVD :$ 349.00
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