Organizing Data and Document Archives Best Practices for Acing Your Next FDA Inspection


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.

Register Now

Speakers Include

  • Mukesh Kumar, Ph.D, Amerax Clinical Research
  • Frederick Stearns, Partner, Keller and Heckman LLP
  • Kazem Kazempour, Ph.D, Amerax Clinical Research
  • Hana Mekonnen, M.S., 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 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

Register Now

What are the benefits of a virtual conference?

  • Highly effective communication: This event uses Internet and audioconferencing to create
    a seamless interface and deliver vital compliance and management advice with every day
    technology found in every workplace.
  • Great value: Select as many of your colleagues to attend as you wish, and then educate
    all of them for one low price, with no travel, lodging or per diem expenses.
  • Stress-free: You never leave your building, so there’s no hotel or airport nightmares. You’ll
    feel like you’re off-site at a top-flight conference, but you’ll still be able to come and go as
    you please and keep track of your daily work.
  • Efficient: You can assign your staff to different sessions.  Staffers can go to the sessions
    that most pertain to their responsibilities.
  • Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and
    get involved.
  • Up to the minute: This program will be up to the minute with the very latest requirements
    from the FDA and other international regulatory bodies incorporated into the event.
  • Comprehensive: You’ll hear from leading industry experts all in the course of one day.

How does a virtual conference work?

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.