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Accredited Online Courses
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Note: Click on each link to go to the course on our website.
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Course CodeCourse NameDurationStatusDue Date
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21 CFR Part 11
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ELM-11221 CFR Part 11 - An Introduction45 minsLiveLive
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ELM-11421 CFR Part 11 - Electronic Records45 minsLiveLive
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ELM-11521 CFR Part 11 - Electronic Signatures45 minsLiveLive
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ELM-11621 CFR Part 11 - Guidance30 minsLiveLive
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21 CFR Part 820
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ELM-30121 CFR Part 820 Subpart A - General Provisions30 minsLiveLive
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ELM-30221 CFR Part 820 Subpart B - Quality System Requirements45 minsLiveLive
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ELM-30321 CFR Part 820 Subpart C - Design Controls45 minsLiveLive
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ELM-30421 CFR Part 820 Subpart D - Document Controls45 minsLiveLive
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ELM-30521 CFR Part 820 Subpart E - Purchasing Controls45 minsLiveLive
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ELM-30621 CFR Part 820 Subpart F - Identification and Traceability45 minsLiveLive
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ELM-30721 CFR Part 820 Subpart G - Production and Process Controls45 minsLiveLive
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ELM-30821 CFR Part 820 Subpart H - Acceptance Activities45 minsLiveLive
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ELM-30921 CFR Part 820 Subpart I - Nonconforming Products45 minsLiveLive
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ELM-31021 CFR Part 820 Subpart J - Corrective and Preventative Action 45 minsLiveLive
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ELM-31121 CFR Part 820 Subpart K - Labeling and Packaging Controls45 minsLiveLive
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ELM-31221 CFR Part 820 Subpart L - Handling, Storage, Distribution, and Installation45 minsLiveLive
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ELM-31321 CFR Part 820 Subpart M - Records45 minsLiveLive
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ELM-31421 CFR Part 820 Subpart N - Servicing45 minsLiveLive
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ELM-31521 CFR Part 820 Subpart O - Statistical Techniques45 minsLiveLive
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ELM-33221 CFR Part 820 - Overview45 minsNot Started 2021
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Good Manufacturing Practices (cGMP) - Begineer
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ELM-710The Devastating Effects of Not Following GMP30 minsLiveLive
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ELM-722An Introduction to GMP45 minsLiveLive
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Good Manufacturing Practices (cGMP) - Intermediate
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ELM-103Good Manufacturing Practices (cGMP)90 minsLiveLive
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ELM-201cGMP Cases From History and the Regulations30 minsLiveLive
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ELM-202cGMP QMS, Premises & Personnel30 minsLiveLive
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ELM-203cGMP Equipment, Validation, Complaints & Self-Inspection30 minsLiveLive
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ELM-204cGMP Good Practices and Quality Control30 minsLiveLive
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Good Manufacturing Practices (cGMP) - Advanced
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ELM-21121 CFR Part 211 Subpart B – Organization and Personnel 45 minsLiveLive
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ELM-20521 CFR Part 211 Subpart C - Buildings and Facilities 45 minsLiveLive
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ELM-21221 CFR Part 211 Subpart D - Equipment 45 minsLiveLive
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ELM-20621 CFR Part 211 Subpart E - Control of Components and Drug Product Containers and Closures45 minsLiveLive
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ELM-20821 CFR Part 211 Subpart F - Production and Process Controls45 minsLiveLive
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ELM-20921 CFR Part 211 Subpart G: Packaging and Labeling Control45 minsLiveLive
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ELM-20721 CFR Part 211 Subpart H - Holding and Distribution45 minsLiveLive
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ELM-21021 CFR Part 211 Subpart J - Records and Reports45 minsLiveLive
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ELM-21321 CFR Part 211 Subpart K - Returned and Salvaged Drug Products45 minsLiveLive
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ELM-120Behavioural Based Quality (BBQ) for a GMP Environment90 minsLiveLive
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Good Manufacturing Practices (cGMP) - China CFDA (Medical Device)
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ELM-330China Food and Drug Administration’s (CFDA’s) - GMP for Medical Devices60 minsLiveLive
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ELM-331China Food and Drug Administration’s (CFDA’s) - GMP for Implantable Medical Devices60 minsLiveLive
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Good Manufacturing Practices (cGMP) - Mexico (Medical Device)
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ELM-217Mexcio Good Manufacturing Practices (cGMP)60 minsNot Started 2021
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Equipment Qualification
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ELM-121Introduction to Risk Based Equipment Qualification60 minsLiveLive
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ELM-150Periodic Review - Equipment45 minsScript Complete TBD
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ELM-128How to Perform a Failure Mode Effect Analysis (FMEA) - Part 145 minsLiveLive
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ELM-130How to Perform a Failure Mode Effect Analysis (FMEA) - Part 245 minsLiveLive
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ELM-107How to Perform Supplier Qualification60 minsLiveLive
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Combination Products: Devices & Biologics
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ELM-145Combination Products - Therapeutic and diagnostic products that combine drugs, devices, and/or biological products - Part 145 minsLiveLive
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ELM-146Combination Products - Therapeutic and diagnostic products that combine drugs, devices, and/or biological products - Part 245 minsLiveLive
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ELM-147Combination Products - Therapeutic and diagnostic products that combine drugs, devices, and/or biological products - Part 345 minsLiveLive
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Computer System Validation (CSV) - Begineer
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ELM-111The Life Cycle of a Software Validation Protocol 60 minsLiveLive
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ELM-113An Introduction to Software Validation Part 160 minsLiveLive
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ELM-119An Introduction to Software Validation Part 260 minsLiveLive
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Computer System Validation (CSV) - Intermediate
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ELM-132Computer System Validation – Basic Concepts, Regulations and GAMP®545 minsLiveLive
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ELM-133Computer System Validation – The Regulated Software Life Cycle45 minsLiveLive
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ELM-134Computer System Validation – Requirements - The Basis for Validation45 minsLiveLive
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ELM-162Computer System Validation – Risk Management 60 minsLiveLive
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ELM-163Computer System Validation – Validation Master Plan 45 minsLiveLive
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ELM-164Computer System Validation – Application of the Validation Plan45 minsLiveLive
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ELM-165AComputer System Validation – Validation Testing - Part 145 minsIn ProductionQ2 2021
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ELM-165BComputer System Validation – Validation Testing - Part 245 minsIn ProductionQ2 2021
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ELM-166Computer System Validation – Maintaining the Validated State 45 minsIn ProductionQ2 2021
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ELM-167Computer System Validation – Special Topics 45 minsScript Complete TBD
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ELM-168Computer System Validation – GAMP 5 45 minsScript Complete TBD
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ELM-149Periodic Review - CSV45 minsScript Complete TBD
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ELM-118Implementing Compliant Systems in a Cloud Environment60 minsLiveLive
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ELM-125Managing and Ensuring Data Integrity of E-Records within a Regulated Environment60 minsLiveLive
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An Introduction to Medical Device Validation
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ELM-156An Introduction to Medical Device Validation - Part 145 minsLiveLive
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ELM-157An Introduction to Medical Device Validation - Part 260 minsLiveLive
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ELM-158An Introduction to Medical Device Validation - Part 360 minsLiveLive
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Contamination Control (Aseptic Techniques)
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ELM-105Contamination Prevention and Control in GMP Environment90 minsLiveLive
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ELM-601An Introduction to Cleaning Validation60 minsLiveLive
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ELM-701Types of Contamination in a GMP Environment30 minsLiveLive
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ELM-702Sources of Contamination in a GMP Environment30 minsLiveLive
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ELM-703Contamination Prevention and Control - Quality Risk Management (QRM)30 minsLiveLive
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ELM-704Contamination Control Strategies in a GMP Environment30 minsLiveLive
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ELM-709An Introduction to Endotoxin Control30 minsLiveLive
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ELM-712How Deviations (Non-Conformance's) Should be Handled from a Regulatory Perspective 30 minsLiveLive
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ELM-713Pharmaceutical Contamination and Microorganisms30 minsLiveLive
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ELM-714Sources of Pharmaceutical Contamination30 minsLiveLive
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ELM-716Contamination Control Strategies - Cleaning and Disinfection30 minsLiveLive
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ELM-717Contamination Control Strategies - Personnel30 minsLiveLive