How many of these pitfalls and traps sound familiar?
Regulatory software experts Jill Iacopi and Lee Knoch will illustrate how companies can avoid the most common pitfalls and increase efficiency and milestone achievements, as well as avoid regulatory sanctions, through the use of an appropriately designed document management system.
Using cases studies, attendees will be guided through examples of how firms tackled and overcame their biggest DMS challenges.
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Learn the benefits of document management systems and how the right one can help with FDA electronic requirements and ensure compliance with agency regulations.
Jill Iacopi is founder and CEO of Moonbay Technology, a software-as-a-service company providing applications for biotechnology and pharmaceutical companies. She has over 14 years of experience in quality and regulatory affairs. In addition to founding Moonbay Technology, Jill has spent the last five years as a regulatory affairs consultant, contracting for small drug-development companies that need assistance with the tactical implementation of regulatory strategy for IND submissions. She is a member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS) and was RAC-certified for three years. Working in quality and regulatory affairs has enabled Jill to understand the regulations and to develop software applications from a drug-development perspective.
Lee Knoch is vice president of sales and marketing at Moonbay Technology. With more than 30 years experience in the high-tech marketplace and almost five years of experience in life sciences, Lee brings extensive sales, marketing and technology experience, as well as substantial industry and eCTD knowledge, to Moonbay. Prior to Moonbay, Lee was president and CEO of a software company that provides eCTD solutions. Lee is a member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS).
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