Bio2Device Group, Tuesday Morning, Nov. 27, 2012 Topic: “How to avoid pitfalls in regulatory documentation and reduce risks during Inspections, Audits, and Litigation” Speaker: Connie Hoy, Vice President of Regulatory Affairs and Quality Assurance Date and Time: Tuesday morning, Nov. 27, 2012, 8:30am Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyale, CA Cost: $0 No registration is required. Topic Description During the course of each day, multiple documents are generated by multiple people in an organization to show compliance to the global regulations and our internal processes. These documents are then filed and, perhaps, never looked at again until there is an inspection by a regulatory body, or worse yet, when there is litigation. This presentation will focus on some of the common mistakes that are made when we generate documentation that can lead to non-conformities during inspections and costly payment during litigation. Some of the things that will be covered include how much detail is enough? How much detail is too much? Why writing in a passive voice is dangerous. What types of language should be avoided altogether? What type of policy should a company have for use of email? This will be an interactive presentation with real life examples and brainstorming with the group. Speaker Bio Connie Hoy has over 28 years’ experience as a regulatory professional. She worked her way up the ladder from a neophyte to a regulatory VP over the course of her career by being hands-on with all areas of regulatory and by working hard to stay on top of the ever changing regulatory climate. She has personally written over 100 510(K) applications and been project leader for ISO implementation and CE marking projects for the last 12 years. Connie is also well versed in international regulatory submissions and has gained product approvals in almost every country in the world. She successfully led the team for a major warning letter at one of her com : free; no registration required