Ofni Clinical Group

Part 11 Compliant Data Management: Doing it Right in the Real World

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FDA requires your investigational drug or medical device data to comply with all of the provisions of 21 CFR Part 11. But how can you generate compliant, reliable data in today’s environment of fewer staff, a disappearing consulting budget and little time for training?

Correctly managing drug or medical device data takes a variety of resources that sponsors, especially smaller firms, rarely have entirely in-house. But business has to run on a realistic budget. How can you balance the necessary requirements with the cost of compliance?

A key tool to minimizing costs and regulatory risks is to find your data management resource gaps…and efficiently fill them.

On Tuesday, April 2 at 1:00pm EDT, join FOI as Russell Barbare, Clinical Operations Manager with Ofni Systems, presents a 90-minute discussion of how to evaluate the skill sets you already have in place for drug or medical device data management – and how you can leverage this knowledge to identify and fill compliance gaps. You’ll hear practical advice on how to implement potential solutions and down-to-earth suggestions for maintaining necessary control in your clinical process.

What You Will Learn

  • The skills you must have available to implement 21 CFR Part 11 and similar regulatory requirements
  • How to maintain control of your compliance
  • The areas most sponsors should probably outsource
  • Practical considerations when dealing with data management budgets
  • How to avoid often-overlooked compliance gaps that could damage your product development

What You Will Get

  • A summary of many of the skills required to produce high quality data
  • Options for data management expenditures
  • Links or references to regulations and resources mentioned in the presentation
  • Practical advice from an instructor who has been involved in drug and medical device data management from preclinical work to final submissions
  • Time for questions and answers

Who Should Attend

  • Clinical data management
  • Regulatory affairs
  • Quality assurance/quality control
  • Clinical software developers
  • Information technology
  • Executives providing input into data management
  • Staff who participate in data management hiring decisions

To Register for this Conference

Click here to register. For more information, or to register over the phone, call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

About Your Instructor

Russell Barbare has spent over decade of experience in clinical trial data management, first as a Data Management Specialist with Gad Consulting Services and subsequently moving to his current position as Clinical Operations Manager with Ofni Systems Inc. This experience has contributed to a large number of successful regulatory filings, covering aspects of development from INDs/IDEs to NDAs/PMAs. Russell has worked on virtually every aspect of clinical data management, including study data collection plans; site and lab auditing; database design and implementation; clinical data software design; regulatory compliance including 21 CFR Part 11 and GxP implementation; data cleaning and extraction; safety, efficacy, and pharmacokinetic analysis; report writing and regulatory submissions. If you would like to know more about the coverage of this presentation, you are invited to contact Russell directly at Russell.Barbare@ofnisystems.com.