FDLI's Form 483 Field Guide webinar puts a panel of experts on a live call to work through how life sciences manufacturers respond once FDA investigators leave a Form 483 behind. The session runs , 12:00–1:30 p.m. ET, and folds in FDA's own draft guidance on responding to 483 observations at the close of a drug CGMP inspection.
Dates and format
- Date: 15 October 2026, 12:00–1:30 p.m. ET
- Format: live virtual webinar
- Fee: $149 members / $249 non-members
- Organizer: Food and Drug Law Institute (FDLI)
What it covers
Form 483 observations are a critical focus for drug, biologic and medical device manufacturers — the list FDA investigators leave at the end of an inspection, and the clock that starts on a manufacturer's written response. This webinar works through current 483 trends, response strategies and common pitfalls, drawing on FDA's recent draft guidance on responding to Form 483 observations for human and animal drug and biologic manufacturers.
Who should attend
Regulatory affairs, quality and compliance staff at drug, biologic and animal-drug manufacturers who draft or review Form 483 responses, along with counsel advising on FDA inspection follow-up. FDLI runs a steady cadence of these short, focused sessions — see FDLI's webinar on the new NDC format for another recent example, or FDLI's Enforcement, Litigation & Compliance Conference 2026 for the deeper enforcement agenda a 483 response can escalate into.
Frequently asked questions
When is the FDLI Form 483 Field Guide webinar?
15 October 2026, 12:00–1:30 p.m. ET, live and virtual. FDLI has not published a recording-access policy in the sources reviewed — check FDLI's own registration page for on-demand availability.
What does the webinar cover?
Current trends in FDA Form 483 inspection observations, response strategies and common pitfalls, with insights from FDA's draft guidance on responding to Form 483 observations at the conclusion of a drug CGMP inspection.
How much does it cost?
$149 for FDLI members and $249 for non-members, per FDLI's own event page.
Who should attend?
Regulatory affairs, quality and compliance professionals at human and animal drug and biologic manufacturers who prepare or review Form 483 responses — FDLI frames the session around that audience specifically.
Sources & further reading
- FDLI. Form 483 Field Guide: FDA Follow-Up for Life Sciences Manufacturers, 10/15/2026. fdli.org
- FDA. Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry. federalregister.gov
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of FDLI's own page rather than a direct fetch, because this session's network egress could not reach fdli.org directly, and no second independent source could be found repeating these facts — confirm the date, price and format with FDLI before registering. Last verified 20 September 2026.
