| Starts: | Thursday March 25, 2010 at 8:30am |
|---|---|
| Ends: | Thursday March 25, 2010 at 12:30pm |
| Event Type: | Training/Seminar |
| Region: | Las Vegas, Nevada Area |
| Location: |
Rio All-Suite Hotel & Casino 3700 W Flamingo Rd Las Vegas, NV 89103 US |
| Price: | $495 |
| Website: | http://www.EduQuest.net/DangerousDocuments.pdf |
| Industry: | pharmaceuticals |
| Keywords: | Enforcement, Documentation, Email, Memo, Document Retention, Risk Management, Investigations, Subpoena, Regulations, Fda, Inspections, Compliance |
| Intended For: | Regulatory Affairs, Human Resources, General Counsel, Quality Assurance, Quality Control, Scientist, Engineer, Manager, Supervisor |
| Organization: | Hands-on training designed for Pharmaceutical, Biologics and Medical Device Companies |
Discover the potential consequences of writing emails and other documents that are inappropriate. You will learn to create correspondence that, if subpoenaed, will demonstrate your firm's commitment to quality and regulatory compliance... instead of exposing costly and embarrassing surprises.
Dangerous Documents has been presented at leading corporations such as Medtronic, Siemens, and Allergan. The course has also been delivered as part of the Masters program at the University of Southern California and at several compliance symposia at Harvard University.
Here’s some of what you will learn at Dangerous Documents: - Who can be held criminally liable under the Federal Food, Drug and Cosmetic Act - What FDA investigators look for when reviewing documents - The risks of leaving blanks and using white-out in required records - How to write informative documents that don't make you a target - How to distinguish between fact and opinion - 8 common practices that are sure to get you in trouble - Why you need to document your risk management activities - The dangers in not monitoring employees emails - 4 types of information never to include in documents - 18 words that will attract the attention of prosecutors or plaintiff's lawyers - Why it is crucial to follow a document retention program - How to write a memo that will be read and acted upon - How to build a program to avoid dangerous documents