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.
course · Coming soon · Date TBD
Computer software assurance workshop
Practice intended-use and risk-based assurance questions for medical device production and quality-system software.
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.
course · Coming soon · Date TBD
Contract laboratory inspection readiness bootcamp
Trace a sample to its report, examine agreements and subcontracting, and rehearse a factual front-room response.
course · Coming soon · Date TBD
Microbiology laboratory record walkthrough
Practice sample identity, media and method records, original observations, review, and handling unexpected results.
course · Coming soon · Date TBD
Chemistry laboratory: reconstruct the result
Connect standards, preparation, instrument evidence, calculations, investigations, and report review.
webinar · Coming soon · Date TBD
OOS investigations: what evidence supports the conclusion?
Separate facts, hypotheses, additional testing, and conclusions in a fictional laboratory investigation.
course · Coming soon · Date TBD
Water systems: a practical records workshop
Map generation, storage, distribution, sampling, trends, and return-to-service evidence without borrowing universal limits.
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
Cleaning, changeovers & validation decisions
Use a fictional changeover to distinguish execution records, routine verification, validation evidence, and impact assessment.
webinar · Coming soon · Date TBD
IVD reagents, labels & lot traceability
Connect reagent genealogy, production history, acceptance, label versions, intended use, and distribution.
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
Device assembly: PCB, manual work & rework
Trace configuration, component identity, work instructions, checks, and authorized rework in a tabletop exercise.
webinar · Coming soon · Date TBD
Packaging & labeling: close the identity gaps
Explore line clearance, reconciliation, material changes, and the evidence supporting an exception decision.
webinar · Coming soon · Date TBD
Cells, blood & biologics: identity at the handoff
Discuss product scope, identity, custody, transfer, storage, and the need for a product-specific regulatory assessment.
webinar · Coming soon · Date TBD
Cosmetics safety files & MoCRA record readiness
Organize formulation identity, safety-supporting information, changes, and applicable responsible-person duties.
course · Coming soon · Date TBD
Dietary supplement component & batch workshop
Practice component acceptance, identity evidence, quality-control decisions, and batch record traceability.
webinar · Coming soon · Date TBD
Clinical trial inspection preparation: source-record retrieval
Map site, sponsor, and vendor responsibilities and practice authorized access without exposing unrelated participant information.
course · Coming soon · Date TBD
Build a new regulated facility: plan the evidence
Bring quality, operations, laboratory, and engineering questions into design and startup-readiness decisions.
webinar · Coming soon · Date TBD
Buying a regulated business: read the quality risks
Distinguish authorizations, registration, inspection history, current operating evidence, and unresolved diligence questions.
webinar · Coming soon · Date TBD
Supplier qualification & outsourced decisions
Map responsibilities and evidence across material suppliers, contract laboratories, service providers, and manufacturing partners.
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.
virtual · Coming soon · Date TBD
Virtual contract laboratory inspection
A six-station fictional walkthrough from arrival to sample traceability, an amended report, and team debrief.
virtual · Coming soon · Date TBD
In the Warroom: company team edition
Customize an invented industry chapter, pause at decision points, and compare the evidence behind different responses.
conference · Coming soon · Date TBD
Salt Lake City inspection learning conference
Proposed one-day conference in the June 2027 planning window. Date, venue, program, presenters, and price are not confirmed.
conference · Coming soon · Date TBD
Contract laboratory quality & outsourcing forum
Proposed in-person forum for laboratory leaders, clients, and quality teams. Location and date TBD, shaped by expressed interest.
conference · Coming soon · Date TBD
International FDA inspection readiness forum
Tell us your country and preferred topics to help shape a future in-person program. No countries, dates, venues, or speakers are confirmed.
conference · Coming soon · Date TBD
IVD & medical device quality leadership forum
Proposed in-person discussion program on practical quality decisions, testing evidence, suppliers, and inspection readiness. Date and location TBD.
course · Coming soon · Date TBD
Analytical method transfer: the receiving-site workshop
Rehearse method handoffs, site differences, open questions and approval responsibilities.
webinar · Coming soon · Date TBD
Reference standards, preparations and result traceability
Follow a fictional reported result back through the standard preparation and its supporting evidence.
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
Instrument service: what supports return to use?
Connect a fictional service change with analytical impact, checks and authorization.
webinar · Coming soon · Date TBD
Contract laboratory OOS communication clinic
Practice a factual first client update while investigation questions remain unresolved.
course · Coming soon · Date TBD
Client specifications and laboratory change decisions
Resolve an invented conflict between the request, method packet and approved instructions.
virtual · Coming soon · Date TBD
Client and contract laboratory: a joint inspection drill
Rehearse a shared record request using invented results and defined access responsibilities.
conference · Coming soon · Date TBD
Laboratory quality leadership and inspection readiness conference
Proposed in-person meeting for laboratory directors, quality leaders and clients. Date, location, speakers and price TBD.
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.
course · Coming soon · Date TBD
Dietary supplement testing and client evidence workshop
Practice component identity, specifications, test records and quality decisions in a fictional exercise.
webinar · Coming soon · Date TBD
IVD testing evidence: controls, lots and configuration
Trace an invented testing decision through reagent lots, controls, method versions and equipment configuration.
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
Buying a laboratory: quality evidence for diligence
Discuss scope, capabilities, inspection history, current records and unresolved diligence questions.
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.
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