Six words not to utter on FDA inspection day:
‘Now, 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. Non-functional (or non-existent) 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.
Who Will Benefit
|10:00 a.m. – 10:15 a.m.||Introduction to the Virtual Conference, Chairperson|
|10:15 a.m. – 11:45 a.m.||Best Practices for Dealing with Raw Data and Data Query Requests from FDA Investigators|
|11:45 a.m. – 12:00 p.m.||Break|
|12:00 p.m. – 1:00 p.m.||Focus on Clinical and Laboratory Data: Practical Steps to Organizing and Presenting Analysis Data|
|1:00 p.m. – 2:00 p.m.||Lunch Break|
|2:00 p.m. – 3:00 p.m.||Hold on a Minute: Understanding the Scope of — and Limitations on — What Documents the FDA Can Ask for During an Inspection|
|3:00 p.m. – 3:15 p.m.||Closing Comments and Adjournment, Chairperson|
Organizing Data and Document Archives takes all the best elements of the best live conference you’ve ever attended – and avoids all the negatives. There’s no hassle getting away from the office, or travel and hotel expenses. Instead, you get valuable intelligence using the Internet for visual components and your speakerphone for the accompanying audio.
On the day of the event, all you do is go to the specified website and dial the specified toll-free telephone number, both provided in your registration confirmation.
That’s all there is to it. Then, relax at your desk or in your conference room, enjoying conference sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where your specific questions will be answered direct answers from leading professionals.
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