Regulatory & Compliance
Are you confident that your work aligns with the most current regulatory compliance requirements? Failure is an expensive lesson that shouldn’t be taken lightly. You can prevent FDA warning letters if you and your team are current on GxP best practices.
Our interactive webinars help you and your team increase your compliance skill and regulatory knowledge– enabling you to ask real life questions to our training experts. On-demand courses enable you to receive just-in-time training that best suits your schedule.
Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.
Browse our regulatory and compliance training courses below.
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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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Regulatory Affairs in China – The New Drug Regulatory FrameworkMichael Zhang, Katrin RupallaOn-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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Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 PandemicMichael PierroOn-Demand00
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Remote Auditing for GMP Compliance During COVID-19: Challenges and OpportunitiesMark Allen DurivageOn-Demand00
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Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 RestrictionsSandra “SAM” SatherOn-Demand00
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Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!Sandra “SAM” SatherOn-Demand00
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Applying Six Sigma Tools and Concepts in Clinical Research: A Process Improvement GuideBetsy FallenOn-Demand00
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New FDA Draft Guidance: A Risk-Based Approach to Monitoring Clinical InvestigationsSandra “SAM” SatherOn-Demand00