This 1-day conference, scheduled for Tuesday, May 3, 2016 in Arlington, Virginia, is for individuals who draft or review documentation relating to the quality of products regulated by FDA. Effective documentation (written communications/company records) is critical to the success of any company, most especially any doing business in a regulated industry. Documents speak for the company and the writer. Documents are subject to misinterpretation by third parties and can subject a firm to unnecessary regulatory action or litigation. Conversely, effective documentation can demonstrate that a company’s quality system and actions are properly functioning to prevent a health risk to consumers from the company’s products. This conference will provide advice on how to create accurate and complete documentation to meet FDA requirements and avoid common pitfalls that can harm the company. Speakers include Stewart Crumpler from Quintiles, and Brian Donato, Jeffrey Shapiro and Roger Thies from Hyman, Phelps & McNamara, P.C. Attendance will be limited to 60 attendees to facilitate interaction with the program faculty.
For more information and to register please visit the conference website and click on the Educational Programs tab. A link to the registration form is available in the course announcement. Payment can be made by check or credit card.
UPDATE: THIS 1-DAY CONFERENCE HAS BEEN CANCELLED.