Medical Device Training
LSTI is a leading training and consulting company for medical device training. We create live and recorded courses for life science professionals and pharmaceutical, medical device, and biotech companies.
FDA requires companies be compliant with patient safety and efficacy. Failure to do so can result in swift consequences for your company.
If you are a medical device manufacturer who wants to ensure your company is meeting FDA and regulatory requirements, contact the Life Science Training Institute for your training needs.
Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.
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How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part PrimerKathleen WarnerOn-Demand00
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It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020Sandra “SAM” SatherOn-Demand00
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Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk MitigationSandra “SAM” SatherOn-Demand00
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Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA GuidanceSandra “SAM” SatherOn-Demand00
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Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 RestrictionsSandra “SAM” SatherOn-Demand00
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Remote Auditing for GMP Compliance During COVID-19: Challenges and OpportunitiesMark Allen DurivageOn-Demand00
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Implementing a Robust Change Control Program – Key Elements for Process and Documentation ComplianceKelly ThomasOn-Demand00
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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAsPenelope Przekop, MSQA, RQAP-GCPOn-Demand00
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The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to ComplyPenelope Przekop, MSQA, RQAP-GCPOn-Demand00
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Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It WorksJoanna GallantOn-Demand00
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Note to File 101: Critical Steps for When, and When Not To, Engage in NTFsLuisa Monica, Jackie MorrillOn-Demand00
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FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best PracticesJoy McElroyOn-Demand10