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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

Apr 22-23 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Course•By Kelly Thomas

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Product image for Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

Analytical Method Validation, Verification & Transfer – FDA & ICH Compliance Training (2 Day)

May 07-08 | 12:00 PM – 05:00 PM ET This training provides a practical, step-by-step approach to analytical method validation, verification, and transfer—helping you implement compliant methods, strengthen documentation, and avoid common pitfalls seen during audits and regulatory reviews. Analytical method validation, verification, and transfer training ensures that laboratory methods are reliable, reproducible, and compliant with FDA, ICH, and USP regulations. Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with Analytical Method Validation.

Course•By Kelly Thomas

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Product image for FDA Inspections 2 Day Virtual Seminar Online

FDA Inspections 2 Day Virtual Seminar Online

May 13-14 This 10-hour seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter. FDA inspections courses provide essential training on GMP compliance, inspection readiness, and interaction with FDA investigators, featuring topics like 483 responses and mock audits. Time 12:00 PM – 05:00 PM ET | 09:00 AM - 02:00 PM PT (US) Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with FDA Inspection

Course•By Kelly Thomas

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Product image for Supplier and Contract Manufacturer Management

Supplier and Contract Manufacturer Management

May 18-19 | Time 12:00 PM – 05:00 PM ET -This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification. Participants will receive a Professional Certificate with 10 hours of Continuing Education aligned with Supplier Management

Course•By Kelly Thomas

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Product image for Biostatistics for the Non-Statistician Course Online

Biostatistics for the Non-Statistician Course Online

May 26-28, 2026 - Biostatistics courses for non-statisticians focus on interpreting data, clinical trial design, and research analysis without heavy mathematics designed for professionals in medicine, pharmaceutical, and biotech fields to master statistical concepts. Earn a Professional Certificate with 15 Hours of Continuing Education Time 12:00 PM – 05:00 PM ET (US)

Course•By Elaine Eisenbeisz

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Product image for FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jun 08-09, 2026, Join our 2-day online FDA Recalls course online to learn proactive strategies for recall preparation and post-recall compliance. You will learn how to proactively prepare for FDA recalls, manage recall execution, understand FDA recall classifications, implement a Recall Management System, handle post-recall reporting, CAPA, and communicate effectively with the FDA.

Course•By Kelly Thomas

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Product image for The EU Clinical Trial Regulation - EU Filings & Registrations

The EU Clinical Trial Regulation - EU Filings & Registrations

Jun 09 This course covers the requirements for conducting Clinical Studies across the EU

Course•By John E Lincoln

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Product image for Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

Pharmaceutical Root Cause Analysis of Failures & Deviations Course Online

Jun 15-18 | Time 12:00 PM – 05:00 PM ET This 20-hour root cause analysis and corrective action course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA

Course•By Kelly Thomas

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Product image for CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems Course

CSV to CSA Transition: 21 CFR Part 11, Data Integrity, Data Privacy, & Use of AI in FDA-Regulated Systems Course

June 16-17, 2026, this 2-day in-person workshop in Richmond, Virginia provides a practical guide to transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) within U.S. Food and Drug Administration-regulated environments. Participants will gain a clear understanding of how to apply CSA principles while maintaining compliance with 21 CFR Part 11, data integrity, and data privacy requirements.

Course•By Carolyn Troiano

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