Organizing Data & Document Archives: Best Practices for Acing Your Next FDA Inspection
All QA/QC managers and staff, document managers and their staff, and regulatory affairs and IT managers and staffs are encouraged to attend online.
For further program details and to register click here.
Six words not to utter on FDA inspection day: "Where is that darn document?"
Paper documents unscanned. Naming conventions that don't make sense. Emails as documentations. Poor communication with the vendors that generate your data. Nonfunctional (or nonexistent) SOPs. Documents missing altogether. Yes, data retrieval is in a sorry state at far too many drug, device, biologics and diagnostics companies.
But your next inspection day need not become scavenger hunt day. Create effective new SOPs for electronic document management, or improve existing ones. It's easy - when you know how and have effective speakers to lead the the way.
PROGRAM HIGHLIGHTS AND AGENDA:
Experienced Speaker Lineup: Experts To Include:
- Mukesh Kumar PhD -- Amerax Clinical Research
- Frederick Stearns -- Partner, Keller & Heckman LLP
- Kazem Kazempour PhD -- Amerax Clinical Research
- Hana Mekonnen MS -- Amerax Clinical Research
Who Will Benefit:
- QA/QC managers and staff
- Document managers and staff
- Regulatory affairs managers and staff
- IT managers and staff
10:00 am-10:15 am Introduction to the Virtual Conference, Chairperson
10:15 am-11:00 am Best Practices for Dealing with Raw Data & Data Query Requests from FDA Investigators
11:00 am-11:45 am Best Practices for Managing the Documentation Management Process & "War Room" in an Increasingly Outsourced Business Environment
11:45 am-12:00 pm Break
12:00 pm-12:45 pm Focus on Clinical & Lab Data: Practical Steps to Organizing & Presenting Analysis Data
12:45 pm-1:45 pm Lunch
01:45 pm-2:30 pm Hold on a Minute: Understanding the Scope of and Limitations on: What Documents the FDA Can Ask for During an Inspection
2:30 pm-3:15 pm Strategizing for Inspection Success: Case Studies in Staging Information During FDA Inspections
3:15 pm-3:30 pm Closing Comments & Adjournment, Chairperson
FURTHER REGISTRATION DETAILS:
Organizing Data and Document Archives: Best Practices for Acing Your Next FDA Inspection
**Virtual Conference** -- Nov 17 2011 | 10:00 a.m. - 3:30 p.m. EST
TUITION: $1,297 per site -- includes virtual conference registration, audio CDs and transcripts
4 EASY WAYS TO REGISTER:
By phone: +1 (888) 838-5578 or +1 (703) 538-7600
Fax: +1 (703) 538-7676
Mail to: FDAnews, 300 N Washington St Ste 200, Falls Church VA USA 22046-3431
You must be entirely satisfied with this learning opportunity or FDAnews will refund your entire tuition, or extend a credit to a future FDAnews conference.
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