FDA’s website has grown to be a vast resource for regulated industry. So much is available that many think that if information isn’t on fda.gov, it doesn’t exist. But there are whole categories of valuable documents FDA does not add to its website; information that you can have if you know what to ask for and precisely how to ask for it under the Freedom of Information Act (FOIA).
FOIA is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the US government, including the FDA. FOIA allows companies to gain information to help them, including establishment inspection reports (EIRs); FDA investigator notes and diaries; and FDA-483s and responses.
This webinar will take you on a down-to-earth tour of the information that is available from FDA using FOIA. The content shared will be of interest to those who need information about how FDA really works, including those involved in regulatory affairs, quality assurance, quality control and related departments, and library and information specialists who research areas affected by FDA.
In addition, executives in upper management now have a huge incentive for seeking insight into FDA actions. The agency has announced a renewed focus on the Park Doctrine, which holds senior management criminally liable for quality failures – regardless of knowledge of, or involvement with, the process or product involved. In some instances, a deeper understanding of the internal workings of FDA may help prevent a criminal conviction, fines and incarceration.
The presenters will address the politics of FOIA to explain the how and why of the underlying Congressional amendments to the Act. Examples of how material obtained under FOIA have been used by the press and watchdog groups to research regulated industry and subsequently inform consumers of real and potential problems will also be shared.
It's clear that almost everyone involved in working with FDA can use FOIA to learn more about the agency's priorities, regulatory interpretations and regulated products and companies. Join us and discover what YOU can discover!
- What FOIA is – and isn’t
- What FDA tells you about using FOIA
- What FDA doesn’t tell you about using FOIA
- Tips for constructing effective FOIA requests
- How long it takes to receive records
- What you can’t get, no matter nicely how you ask
- Various types of records to consider requesting – and how to get them
- What you can expect to learn from each record type
Who Should Attend
Professionals who work in the areas of regulatory affairs, quality assurance, quality control and related departments, and library and information specialists.
At the conclusion of this webinar, participants should be able to:
- Discuss the intricacies of the Freedom of Information Act (FOIA)
- Identify how to place a request under the FOIA, and what information you can gain and what you can do with it
for minimum system requirements.