CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
August 23 & 24, 2018
Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)
If you didn't write it down, it didn't happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.
Who Should Attend
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.