Coming soon: FDA inspection webinars, courses & conferences
Help shape the next program. These are proposed topics with dates, times, speakers, venue, and prices to be confirmed. Join a specific interest list; no booking or payment is created. Programs can be customized for companies, including contract laboratories.
webinar · Coming soon · Date TBD
AI in the quality unit: evidence before automation
Discuss intended use, source verification, human review, and the limits of AI-generated summaries in quality work.
webinar · Coming soon · Date TBD
AI-enabled devices: lifecycle and change questions
Explore training questions about data, intended use, performance monitoring, changes, and the FDA resources relevant to AI-enabled devices.
webinar · Coming soon · Date TBD
AI in contract laboratories: protect the evidence trail
Discuss how proposed AI assistance might affect original data, method decisions, review, reporting, and client expectations.
webinar · Coming soon · Date TBD
Electronic records, audit trails & human review
Follow a fictional record through access, change, review, retention, and retrieval; discuss applicability before making Part 11 claims.
webinar · Coming soon · Date TBD
Aseptic processing & blow-fill-seal interfaces
Discuss interventions, container formation, filling, closure, and the evidence boundaries in a proposed manufacturing case.
course · Coming soon · Date TBD
Molecular & immunoassay IVD evidence workshop
Practice reagent, control, run, configuration, and interpretation traceability using fictional training records.
course · Coming soon · Date TBD
Form 483 response planning: from observation to evidence
Practice issue scope, containment, investigation, action, and follow-up using a fictional exercise and an independent planning worksheet.
course · Coming soon · Date TBD
Chromatography review and reprocessing decisions
Practice explaining a changed processing decision without losing the original evidence trail.
webinar · Coming soon · Date TBD
Interrupted runs, recovery and laboratory continuity
Explore a tabletop interruption, retained evidence, recovery responsibilities and reporting decisions.
webinar · Coming soon · Date TBD
Contract laboratory OOS communication clinic
Practice a factual first client update while investigation questions remain unresolved.
conference · Coming soon · Date TBD
Digital laboratory evidence and AI forum
Proposed forum on computerized records, human review, recovery and proposed AI assistance. Date, location, speakers and price TBD.
webinar · Coming soon · Date TBD
Cosmetics testing: explain the laboratory handoff
Discuss product scope, safety-supporting records, test instructions and client communication.
webinar · Coming soon · Date TBD
Clinical trial vendors: prepare the inspection record map
Discuss authorized record retrieval and the site, sponsor and laboratory interfaces using training examples.
webinar · Coming soon · Date TBD
Fractional QA for laboratories: define the responsibility map
Explore part-time quality leadership, reporting, availability and decision boundaries before an engagement.
Vote for your preferred topic · Propose a speaker or sponsor partnership · Confirmed-date events calendar
What would you like us to cover?
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