Organizing Data and Document Archives Virtual Conference Agenda

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
FDA investigators come to inspect an establishment with advance notice or without advance notice, for cause (e.g., death, SAEs, AES, etc.) or just as a random inspection.  No matter what the motivation your responsibilities are the same — you must provide all required information and cooperated with the FDA investigators.  In this talk we focus on the raw data related and query related issues; and how to be prepared for an FDA inspection from the data, query generation and resolution point of view.

Attendees will learn:

  • How to develop successful flow charts presenting the steps in raw data collection, query generation/resolution, and updating databases
  • Understanding the similarities and differences for dealing with data requests during a routine audit and a random audit
  • Tips for assuring you are delivering factual data during an inspection
  • The how and why of what to present at the time of audit — the answers might surprise you
  • Be prepared — 10 important steps you must take in preparation for an audit

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
Final data — or sometimes called analysis data — that is submitted to the FDA are the bases of nearly all conclusions.  These tables, graphs and listings are the heart and soul of your clinical and laboratory data, and of particular interest to FDA investigators.  These data are either directly obtained from the patients/subjects or they are calculated based on some formulae.  In either case the steps should be well defined, the results should be clearly presented and documented, and above all they should be reproducible.  In this presentation you’ll learn time-tested methods to organize and present summary tables, graphs and descriptive or inferential statistics. The presenters will detail the practical steps in prepping for an FDA inspection from an analysis data, derived data point of view.

Attendees will learn:

  • Compliance driven steps to document analysis data sets to FDA’s satisfaction
  • What are common mistakes made when presenting analysis data sets during an inspection?
  • Document, document, document — how to document the steps taken in derived data
  • Who should be present at the time of FDA an audit to help explain C&L data

1:00 p.m. – 2:00 p.m.

Lunch

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
FDA investigators can sometimes ask for information to which they are not legally entitled. Company personnel need to understand these limits (and how to respond when FDA tries to go beyond them) to protect their businesses. It is crucial to understand the scope of (and limitations on) FDA’s inspection authority.

Attendees will learn:

  • Steps your company should take to be compliant and prepared in advance of an inspection
  • What one thing you should never do when asked by an FDA investigator
  • How to successfully push back on requests to take photographs
  • Keys to setting the tone of the inspection

3:00 p.m. – 3:15 p.m.

Closing Comments and Adjournment, Chairperson