Dangerous Documents: Avoiding Land Mines In Your FDA Records and Emails
Friday, January 23, 2009
Orlando, FL | The Regal Sun Resort
Guidant, Merck, Bayer, Eli Lilly, and American Home Products were sued. During discovery, they were forced to produce their employees’ emails and other documents that they thought were confidential. These documents contained inflammatory statements that embarrassed the companies. They had to enter into expensive settlements. A Google search revealed that Microsoft was subject to the same fate, as Bill Gates wrote in an email, “How much do we have to pay you to screw Netscape?” If your employees haven’t been trained on how to write complete, accurate emails and documents that show the depth of your corporate culture of compliance, your firm could be subject to a similar costly result.
AdvaMed in cooperation with Compliance-Alliance is offering a one-day session titled “Dangerous Documents: How to Avoid Land Mines in Your FDA Records and Emails. Using case studies, discussions and role playing, you will learn 8 common practices that will get you into trouble, words that will attract a prosecutor’s attention and the dangers in not monitoring employees emails. 
Reuters New Service wrote an article on the Orlando Dangerous Documents course. See what the press had to say by following this link: http://www.reuters.com/article/lifestyleMolt/idUSTRE5075SA20090108
Who Should Attend
Company officials who work in the area of RA, QA, R&D, legal, compliance and manufacturing.
Registration
| AdvaMed Member | $795 | Register Now |
| Non-Member | $995 | |
| AdvaMed EGCC Member | $495 | |
| Government | $250 |
Agenda Overview
Program Content:
Using case studies, role playing exercises and discussions, you will learn:
- 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 prosecutor's or plaintiff's lawyer
- Why it is crucial to follow a document retention program
- How to write a memo that will be read and acted upon
Schedule of Events:
8:30 – 9:00 Registration and Continental Breakfast
9:00 – 12:00 Morning Session
12;00 – 1:00 Lunch
1:00 – 3:00 Afternoon Session
Speakers
Nancy Singer, President, Compliance-Alliance (Former prosecutor and defense attorney)
Tom Maeder, Executive Director, MTLI, AdvaMed (Author and Science Writer)
General Information
We are offering an additional ten percent discount if you register for the Compliants, Enhancing Safety Risk Management, Risk Based Strategies or the Validation of Non-Product Software seminars in addition to this one. In order to receive the discount registrations for Dangerous Documents must be faxed to Katia Kunze at 202-783-8750.
It is the responsibility of the registrant to verify their company’s active membership status prior to registering. You may check if your company is an active member visiting http://www.advamed.org/MemberPortal/Membership/member_company_listing.htm. There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company. Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.
To receive discounts for registering 3 or more please fax your registration to the attention of Katia Kunze at 202-783-8750. Discounts will not be given retroactively.
For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen. For information regarding Registration issues, please contact Katia Kunze.
Please be advised that any registrations received after 5 pm on Wednesday January 7th will not appear on the participants roster. It is MTLI policy not to release revised participants rosters after the seminar.
CANCELLATION & REFUND POLICY
Location Information
The Regal Sun Resort1850 Hotel Plaza Blvd
Lake Buena Vista, FL 32830
407-827-6529
A limited block of sleeping rooms have been arranged at the Regal Sun Resort for attendees to these Seminars, for a reduced rate of $139/lake view or $159/tower/city view. In order to receive the discounted rate, you must ask for the Advance Medical Technology Association room block. To make toll free reservations please contact 1-800-624-4109. Please make your reservations early as this rate is effective until January 9, 2008. Rates and room availability are subject to change after the January 9th date.