Proposed Laboratory Webinars

No dates or speakers confirmed; registration is interest only.

Scoping IEEE Electrical and Interface Testing

An independent Laboratory Vortex educational proposal, not organized, certified or endorsed by IEEE. Define equipment, interface, configuration and measurement objectives before selecting a designation and edition; distinguish shielding measurement from product safety and broader EMC evidence.

IVD Analytical Performance: Scoping the Evidence

Turn assay intended use into a proportionate analytical study brief: precision, detection capability where appropriate, range, interference and method comparison. Analytical evidence does not establish clinical sensitivity or specificity; RUO and clinical IVD claims differ.

Medical Polymers and Colorants: Evaluating a Change

Scope a reference-versus-candidate comparison using documented composition, manufacturing, contact and exposure. Discuss provider-proposed material identification and chemistry, and risk-based biological evaluation without assuming a resin, test panel or acceptance limit.

Extractables, Leachables and Choosing a Method

A practical brief for material composition, extraction studies, use-related release and toxicological interpretation. Distinguish a standard, specification and test method; choose applicable official documents and ask providers to propose extraction conditions and analytical coverage.

Using AI in Your Laboratory

Where AI-enabled tools can help routine laboratory work today, where human review stays essential, and how to run a small, measurable pilot without putting data integrity or client confidentiality at risk.

Laboratory Equipment Qualification & Validation

An overview of design, installation, operational and performance qualification for laboratory instruments, how qualification relates to calibration and method validation, and what records auditors typically review.

Choosing a LIMS for a Growing Contract Laboratory

How contract laboratories can define LIMS requirements around client portals, quoting, sample accessioning, instrument interfaces, reporting and validation — and how to compare vendors without relying on feature lists alone.

Data Integrity and AI-Enabled Lab Software

Applying ALCOA+ data-integrity principles, audit trails, access control and electronic-record requirements to software that includes AI or machine-learning features, including where 21 CFR Part 11 may apply.

Winning Laboratory Testing Contracts and RFQs

How laboratories can find government and commercial testing solicitations, read scope and qualification requirements, and prepare clear, compliant responses that reflect real capacity and accreditation scope.

Buying Used or Refurbished Lab Equipment

What to check before buying pre-owned instruments: provenance, operating condition, decontamination, software licences, service support, shipping and requalification costs.

How to Obtain ISO/IEC 17025 Accreditation

A practical roadmap from gap analysis to accreditation decision: choosing an accreditation body that is a signatory to the ILAC mutual recognition arrangement, defining a realistic scope, building the management system and technical records ISO/IEC 17025:2017 expects, and planning proficiency testing and internal audits before application.

Buying Used Laboratory Instruments: Inspection, Qualification and Risk

A risk-based approach to pre-owned instruments: verifying seller and provenance, inspecting condition and service history, confirming decontamination, checking software and licence transfer, and planning installation and operational qualification before the instrument is used for reportable results.

FDA Regulations and GMP for Testing Laboratories

An orientation to the FDA requirements that commonly reach testing laboratories serving regulated clients — including laboratory controls under 21 CFR 211 for drug products, quality system expectations for devices, and how client audits and FDA inspections examine laboratory records. Applicability depends on each client's product and regulatory status.

Regulatory Requirements for CROs and Contract Testing Laboratories

How GLP (21 CFR Part 58), GMP, GCP-adjacent laboratory work and ISO/IEC 17025 expectations differ, how sponsors allocate responsibilities through quality agreements, and what documentation contract organisations are expected to maintain. Requirements vary by study type, jurisdiction and client.

Laboratory Data Integrity and 21 CFR Part 11

Applying ALCOA+ principles and FDA's electronic records and signatures rule (21 CFR Part 11) to chromatography data systems, LIMS and spreadsheets: audit trails, access control, electronic signatures, review of audit trails, and the scope and enforcement approach described in FDA guidance.

Method Validation and Verification for Contract Laboratories

When a contract laboratory must validate a method versus verify a standard method, which performance characteristics are typically assessed (for example accuracy, precision, specificity, range, LOD/LOQ and robustness), and how ICH Q2(R2), USP general chapters and ISO/IEC 17025 clause 7.2 frame the work.

Preparing for an ISO/IEC 17025 Assessment

What happens during an initial or surveillance assessment, how assessors sample records and witness testing, how to prepare staff and evidence, and how to respond to nonconformities with root-cause analysis and corrective action within the accreditation body's deadlines.

Laboratory Quality Management and CAPA

Building a corrective and preventive action process that works: capturing nonconformities and complaints, proportionate investigation, root-cause tools, effectiveness checks and trend review — and linking CAPA to management review and risk-based thinking in ISO/IEC 17025 and GMP environments.

How to Win Government Laboratory RFQs

Finding laboratory testing, equipment and service solicitations on official US and Canadian portals, registering correctly (for example SAM.gov or CanadaBuys), reading statements of work and evaluation criteria, and preparing compliant, truthful responses.

Scaling a Contract Testing Laboratory

Operational decisions behind growth: capacity planning, instrument and staffing investment, extending accreditation scope, pricing and turnaround commitments, client mix, and when to add LIMS, automation or a second site.

LIMS Selection and Implementation

From requirements to go-live: documenting workflows, comparing vendors with scripted demonstrations, planning data migration and instrument interfaces, validating the configured system for intended use, and managing training and cut-over.

Laboratory Automation and AI

Where robotic sample handling, scheduling software and AI-assisted analysis fit in testing laboratories, how to estimate throughput benefits, and how to keep validation, data integrity and human review in place as automation increases.

Equipment Calibration and Preventive Maintenance

Setting calibration intervals, choosing calibration providers with suitable accredited scope and metrological traceability, reviewing certificates and measurement uncertainty, and building preventive maintenance and intermediate checks into the equipment programme.

Laboratory Biosafety and Sample Handling

Risk assessment for biological samples, biosafety levels as described in the CDC/NIH BMBL, sample receipt, chain of custody, storage, packaging and shipping considerations, and waste handling. Requirements depend on agent, jurisdiction and institutional policy.

Laboratory Startup and Facility Planning

Planning a new laboratory: defining services and scope, site selection or shared lab space, utilities, ventilation and safety, equipment lists and budgets, permits, staffing, and the sequence toward first client work and accreditation.

FDA Inspections of Testing Laboratories: Readiness, Findings and CAPA

Teaser only: this proposed session's primary landing page and interest signup are on FDAinspections.com. It is intended to cover inspection readiness, common laboratory-related observations and building effective CAPA responses.

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