Accredited Courses

Code Title Duration Version
CCL-103 Introduction to the General Data Protection Regulation (GDPR) 15 mins V2.0
CCL-105 Doing the Right Thing: Anti-Bribery 25 mins V1.1
CCL-106 HIPAA – Health Insurance Portability and Accountability Act 15 mins V1.1
CCL-107 Cybersecurity 15 mins V1.0
CCL-108 Sunshine Act 15 mins V1.0
CCL-109 Workplace Harassment and Bystander Intervention 15 mins V1.1
CCL-110 Level Up Your Leadership: Essential Attributes for Modern Managers 20 mins V1.0
EHS-102 Laboratory Physical Hazard Identification 15 mins V1.1
EHS-104 Bloodborne Pathogen 5 mins V1.0
EHS-108 PPE Safety 5 mins V1.0
EHS-109 Fire Extinguisher Training 5 mins V1.0
EHS-110 Ladder Safety 5 mins V1.0
EHS-111 Slips, Trips and Falls 5 mins V1.0
EHS-112 Hazard Communication (HazCom) 5 mins V1.1
EHS-113 Hazardous Waste Generator 5 mins V1.0
ELM-101 Good Laboratory Practices: History and Regulatory Compliance 20 mins V4.1
ELM-102 Laboratory Data Integrity 15 mins V3.0
ELM-106 How to Prepare for Internal & External Laboratory Audits 60 mins V1.0
ELM-107 How to Perform Supplier Qualification 60 mins V1.0
ELM-108 Laboratory Investigations & Deviations 60 mins V1.0
ELM-109 Performing Analytical Analysis in a Regulated Laboratory 60 mins V1.0
ELM-110 Premises, People, and Animal Welfare in GLP 60 mins V2.0
ELM-111 The Life Cycle of a Software Validation Protocol 60 mins V3.0
ELM-112 21 CFR Part 11 – An Introduction 15 mins V1.2
ELM-114 21 CFR Part 11 – Electronic Records 45 mins V1.1
ELM-115 21 CFR Part 11 – Electronic Signatures 45 mins V1.1
ELM-116 21 CFR Part 11 – 2003 Guidance 20 mins V1.2
ELM-117 CAPA and Effectiveness Checks 20 mins V3.0
ELM-120 Elevating Quality Culture through Positive Behaviors 20 mins V3.1
ELM-121 Risk Based Equipment Qualification 15 mins V2.1
ELM-122 How to be an Effective GMP Auditor – Part 1 45 mins V3.0
ELM-123 How to be an Effective GMP Auditor – Part 2 35 mins V2.1
ELM-124 How To Be An Effective GMP Auditor – Part 3 45 mins V1.0
ELM-126 How to Write Effective Standard Operating Procedures (SOPs) 60 mins V1.1
ELM-127 How to Write an Effective Equipment User Requirement Specification (URS) 60 mins V1.0
ELM-132 Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5 45 mins V2.1
ELM-133 Computer System Validation – The Regulated Software Life Cycle 60 mins V1.1
ELM-134 Computer System Validation – Requirements: The Basis for Validation 60 mins V1.0
ELM-135 Medical Device Single Audit Program (MDSAP) – Part 1 45 mins V1.0
ELM-136 Medical Device Single Audit Program (MDSAP) – Part 2 45 mins V1.0
ELM-137 Medical Device Single Audit Program (MDSAP) – Part 3 45 mins V1.0
ELM-138 Medical Device Single Audit Program (MDSAP) – Chapters 1 to 4 60 mins V2.0
ELM-139 Medical Device Single Audit Program (MDSAP) – Chapters 5 to 7 60 mins V2.0
ELM-140 MDSAP Country Specific Requirements (Australia) 45 mins V2.0
ELM-141 MDSAP Country Specific Requirements (Brazil) 45 mins V2.0
ELM-142 MDSAP Country Specific Requirements (Canada) 60 mins V2.0
ELM-143 MDSAP Country Specific Requirements (USA) 60 mins V2.0
ELM-144 MDSAP Country Specific Requirements (Japan) 45 mins V2.0
ELM-145 Combination Products (Drugs, Devices and Biologics) – Part 1 45 mins V2.0
ELM-146 Combination Products (Drugs, Devices and Biologics) – Part 2 45 mins V1.0
ELM-147 Combination Products (Drugs, Devices and Biologics) – Part 3 45 mins V1.0
ELM-148 An Introduction to Data Integrity Awareness 45 mins V1.5
ELM-149A Computer System Validation: Periodic Review Strategies Part 1 45 mins V1.0
ELM-149B Computer System Validation: Periodic Review Strategies Part 2 45 mins V1.0
ELM-151 Data Integrity Awareness: Health Authorities 45 mins V1.0
ELM-152 Data Integrity Awareness: ALCOA+ 15 mins V3.0
ELM-153 Data Integrity Awareness: Good Documentation Practices 40 min V1.2
ELM-154 Data Integrity Awareness: CSV Best Practices 45 mins V1.0
ELM-155 Data Integrity Awareness – Data Governance 45 mins V1.0
ELM-156 An Introduction to Medical Device Validation – Part 1 45 mins V1.0
ELM-157 An Introduction to Medical Device Validation – Part 2 60 mins V1.0
ELM-158 An Introduction to Medical Device Validation – Part 3 60 mins V1.0
ELM-159 Change Control: Regulations and Guidelines 30 mins V3.0
ELM-160 Change Control and Change Management 45 mins V2.0
ELM-161 The Lifecycle of a Change Control Program – Phase 1: Develop the Change Request 45 mins V1.0
ELM-162 Computer System Validation – Risk Management 60 mins V1.0
ELM-163 Computer System Validation – Validation Master Plan 45 mins V1.0
ELM-164 Computer System Validation – Application of the Validation Plan 30 mins V1.0
ELM-165A Computer System Validation (CSV) – Validation Testing Part 1 45 mins V1.0
ELM-165B Computer System Validation (CSV): Validation Testing – Part 2 45 mins V1.0
ELM-166A Computer System Validation – Maintaining the Validated State 45 mins V1.1
ELM-166B Computer System Validation – Supplier Provided Software 45 mins V1.1
ELM-167 Computer System Validation (CSV) – Special Topics 45 mins V1.0
ELM-174 The Basics of Laboratory Investigations 45 mins V1.0
ELM-175 How to Conduct a Laboratory Investigation 45 mins V1.0
ELM-178 The Lifecycle of a Change Control Program – Phase 2: Evaluate 45 mins V1.0
ELM-179 The Lifecycle of a Change Control Program – Phase 3: Implement and Phase 4: Review 45 mins V1.0
ELM-180 The Lifecycle of a Change Control Program – Examples of Change Controls, Documents & Recording Completed Changes 30 mins V1.0
ELM-181 Commissioning Qualification and Validation the Concept of CQV – Part 1 30 mins V1.0
ELM-182 Commissioning Qualification and Validation the Concept of CQV – Part 2 30 mins V1.0
ELM-183 Commissioning Qualification and Validation the Concept of CQV – Part 3 45 mins V1.0
ELM-190 General Inspection Readiness 20 mins V2.1
ELM-191 Inspection Readiness: Your Role & Preparing for Inspector Interactions 25 mins V1.4
ELM-192 Protocols, SOPs, and Quality Assurance Functions in GLP Environments 10 mins V1.1
ELM-193 Test Systems, Test Articles, and Safety Endpoints in GLP Protocols 15 mins v1.0
ELM-194 GLP Records, Retention, and Disqualification 15 mins V1.0
ELM-195 Computer Software Assurance (CSA) 15 mins V1.0
ELM-196 Deviation – Initiator 15 mins v1.0
ELM-197 Deviation – Investigator 20 mins 1.0
ELM-201 cGMP – Cases from History and the Regulations 30 mins V3.1
ELM-202 Good Manufacturing Practices – QMS, Premises and Personnel 30 mins V1.0
ELM-203 cGMP – Equipment, Validation, Complaints and Self Inspection 30 mins V2.0
ELM-204 Good Manufacturing Practices – Good Practices and Quality Control 30 mins V1.0
ELM-205 21 CFR Part 211 Subpart C – Building and Facilities 45 mins V1.0
ELM-206 21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures 45 mins V1.0
ELM-207 21 CFR Part 211 Subpart H – Holding and Distribution 30 mins V1.0
ELM-208 21 CFR Part 211 Subpart F: Production and Process Controls 45 mins V1.0
ELM-209 21 CFR Part 211 Subpart G: Packaging and Labeling Control 45 mins V1.0
ELM-210 21 CFR Part 211 Subpart J – Records and Reports 45 mins V1.0
ELM-211 21 CFR Part 211 Subpart B: Organization and Personnel 45 mins V1.0
ELM-212 21 CFR Part 211 Subpart D – Equipment 45 mins V1.0
ELM-213 21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products 45 mins V1.0
ELM-219 The Fundamentals of Good Manufacturing Practices 15 mins V2.2
ELM-220 The Fundamentals of Good Documentation Practice 15 mins V4.0
ELM-221 The Fundamentals of Data Integrity 10 mins V4.2
ELM-222 The Fundamentals of Contamination Control 20 mins V2.1
ELM-223 The Fundamentals of Good Laboratory Practices (cGLP) 20 mins V1.3
ELM-224 The Fundamentals of GxP in a Regulated Environment 20 mins V3.0
ELM-226 The Fundamentals of Corrective and Preventive Actions (CAPA) 20 mins V1.3
ELM-227 The Fundamentals of Deviations 20 mins V 1.1
ELM-228 The Fundamentals of Inspection Readiness 15 mins V1.1
ELM-229 The Fundamentals of Quality Control 15 mins V1.1
ELM-230 The Fundamentals of Computer System Validation 25 mins V1.2
ELM-232a The Fundamentals of Quality Risk Management (QRM) 20 mins V1.8
ELM-232b Quality Risk Management (QRM): Global Regulations and Their Impact 15 mins V1.5
ELM-233 ICH Q10 – Management Responsibilities 20 mins V1.0
ELM-234 The Fundamentals of Good Distribution Practice 10 mins 2.1
ELM-235 Good Distribution Practices: Core Principles 10 mins V2.0
ELM-237 ICH Q9 – Quality Risk Management 25 mins V1.1
ELM-238 ICH Q9 – Risk Management Methods and Tools 20 mins V1.0
ELM-239 QRM as Part of Integrated Quality Management 20 mins V1.0
ELM-240 Good Distribution Practices: Operational Principles 15 mins V2.1
ELM-244 Human Error Prevention 20 mins V1.0
ELM-247 The Fundamentals of Change Control 15 mins V1.1
ELM-250 Change Control: Core Concepts 20 mins V1.1
ELM-257 Train the Trainer: Adult Learning Theory 15 mins V1.0
ELM-258 Supplier Quality Management 15 mins v1.0
ELM-259 Customer Complaint Handling 15 mins V1.0
ELM-263 Batch/Product Release 15 mins v1.0
ELM-264 Equipment Maintenance 15 mins 1.0
ELM-301 21 CFR Part 820 Subpart A – General Provisions 30 mins V1.0
ELM-302 21 CFR Part 820 Subpart B – Quality System Requirements 30 mins V1.0
ELM-303 21 CFR Part 820 Subpart C – Design Controls 60 mins V1.1
ELM-304 21 CFR Part 820 Subpart D – Document Controls 45 mins V1.0
ELM-305 21 CFR Part 820 Subpart E – Purchasing Controls 45 mins V1.0
ELM-306 21 CFR Part 820 Subpart F – Identification and Traceability 60 mins V1.0
ELM-307 21 CFR Part 820 Subpart G – Production and Process Controls 45 mins V1.0
ELM-308 21 CFR Part 820 Subpart H – Acceptance Activities 45 mins V1.0
ELM-309 21 CFR Part 820 Subpart I – Nonconforming Products 60 mins V1.0
ELM-310 21 CFR Part 820 Subpart J – Corrective and Preventive Action 45 mins V1.0
ELM-311 21 CFR Part 820 Subpart K: Labeling and Packaging Control 45 mins V1.0
ELM-312 21 CFR Part 820 Subpart L – Handling, Storage, Distribution and Installation 45 mins V1.1
ELM-313 21 CFR Part 820 Subpart M – Records 45 mins V1.0
ELM-314 21 CFR Part 820 Subpart N – Servicing 45 mins V1.0
ELM-315 21 CFR Part 820 Subpart 0 – Statistical Techniques 45 mins V1.0
ELM-316 EU Medical Device Regulation (EU MDR) – Introduction 60 mins V1.0
ELM-317 EU Medical Device Regulation (EU MDR) – Chapter I: Scope and Definitions 45 mins V1.0
ELM-318 EU Medical Device Regulation (EU MDR) – Chapter 2: Making Available on the Market 60 mins V1.0
ELM-319 EU Medical Device Regulation (EU MDR) – Chapter 3: Identification, Traceability and Registration of Devices 60 mins V1.0
ELM-320 EU Medical Device Regulation (EU MDR) – Chapter 4: Notified Bodies 45 mins V1.0
ELM-321 EU Medical Device Regulation (EU MDR) – Chapter 5: Classification and Conformity 45 mins V1.0
ELM-322 EU Medical Device Regulation (EU MDR) – Chapter 6 – Clinical Evaluation and Clinical Investigations 45 mins V1.0
ELM-323 EU Medical Device Regulation (EU MDR) – Chapter 7 – Post Market Surveillance, Vigilance and Market Surveillance 45 mins V1.0
ELM-324 EU Medical Device Regulation (EU MDR) – Chapter 8 – Cooperation Between Member States 30 mins V1.0
ELM-325 EU Medical Device Regulation (EU MDR) – Chapter 9 – Confidentiality, Data Protection, Funding and Penalties 30 mins V1.0
ELM-326 EU Medical Device Regulation (EU MDR) – Chapter 10 – Final Provisions 30 mins V1.0
ELM-327 EU Medical Device Regulation (EU MDR) – Chapters 1 to 5 60 mins V1.0
ELM-328 EU Medical Device Regulation (EU MDR) – Chapters 6 to 10 60 mins V1.0
ELM-330 China Food and Drug Administration’s (CFDA’s) – GMP for Medical Devices 60 mins V1.0
ELM-331 China Food and Drug Administration’s (CFDA’s) – GMP for Implantable Medical Devices 60 mins V1.0
ELM-333 ISO 14971 – The Scope of the Standard 30 mins V2.1
ELM-334 ISO 14971:2019: The Evolution and Definitions 45 mins V1.0
ELM-335 ISO 14971:2019: Basic Framework for Risk Management 45 mins V1.0
ELM-336 ISO 14971: Characterizing the Device & Identifying Hazards 45 mins V1.0
ELM-337 ISO 14971:2019: Risk Analysis, Evaluation & Control 45 mins V2.0
ELM-338 ISO 14971:2019: Different Perspectives of a Risk Management Program 45 mins V1.0
ELM-401 Process Validation: Core Concepts 15 mins V2.0
ELM-402 An Introduction to Process Validation – Part 2 60 mins V1.1
ELM-404 Root Cause Analysis 30 mins v1.0
ELM-405 Serious Breaches 15 mins v1.0
ELM-501 Good Documentation Practices – General Rules of Data Integrity 30 mins V1.0
ELM-502 Good Documentation Practices – Making Correction to Ensure Data Integrity 30 mins V1.0
ELM-503 Good Documentation Practices – Logbook Data Integrity 30 mins V1.0
ELM-504 Good Documentation Practices – Data Integrity for General Test Results 30 mins V2.0
ELM-505 Technical Writing in a Regulated or Accredited Environment 20 mins V2.0
ELM-601 An Introduction to Cleaning Validation 60 mins V2.0
ELM-701 Types of Contamination in a GMP Environment 15 mins V3.0
ELM-702 Sources of Contamination in a GMP Environment 10 mins V 3.0
ELM-704 Contamination Control Strategies in a GMP Environment 15 mins V3.0
ELM-705 Microbiological Contamination of Pharmaceutical Products – Part 1 45 mins V1.0
ELM-706 Microbiological Contamination of Pharmaceutical Products – Part 2 60 mins V1.0
ELM-707 The Basic Principles of Isolator Technology 45 mins V1.0
ELM-708 Restricted Access Barrier Systems (RABS) Glove Training 45 mins V1.0
ELM-709 An Introduction to Endotoxin Control 30 mins V1.0
ELM-710 The Devastating Effects of Not Following GMP 15 mins V2.2
ELM-711 Pharmaceutical Microbiology and Industry Considerations 30 mins V1.0
ELM-715 The Use of Vaporized Hydrogen Peroxide (VHP) Chambers 30 mins V1.0
ELM-719 Microbiological Environmental Monitoring 30 mins V1.0
ELM-720 Control of Microbiological Contamination in a GMP Environment 30 mins V1.0
ELM-721 Microbiological Testing Methods 30 mins V1.0
ELM-725 The Fundamentals of Cell and Gene Therapy 15 mins V1.1
ELM-726 The Fundamentals of Biotech Manufacturing 10 mins V1.0
ELM-733 Biotech Manufacturing: Aseptic Processing 10 mins V1.1
ELM-736 In-Process Sampling and Testing 15 mins V1.0
ELM-737 Plant and Clean Utilities for GMP Manufacturing 15 mins V1.0
ELM-739 Winning Cleanroom Behaviors 10 mins V1.1
ELM-743 The Fundamentals of Quality Management Systems – Pharma 15 mins V1.0
ELM-801 ISO 13485:2016 – Chapter 1-3: Introduction 45 mins V1.0
ELM-802 ISO 13485:2016 – Chapter 4: The Quality Management System (QMS) 60 mins V1.0
ELM-803 ISO 13485:2016 – Chapter 5: Management Responsibility 45 mins V1.0
ELM-804 ISO 13485:2016 – Chapter 6: Resource Management 45 mins V1.0
ELM-805 ISO 13485:2016 Product Realization (Chapter 7 – Part A) 60 mins V1.0
ELM-806 ISO 13485:2016 – Product Realization (Chapter 7 – Part B) 45 mins V1.0
ELM-807 ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A) 45 mins V1.0
ELM-808 ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B) 45 mins V1.0
ELM-904 ICH E6 – Introduction and Principles of Good Clinical Practices (GCP) (Sections 1-2) R2 30 mins V1.2
ELM-906 ICH E6 – Investigator (Chapter 4) (R2) 15 mins V1.0
ELM-909 21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 1] 45 mins V1.0
ELM-910 21 CFR Part 50 Subpart B: Informed Consent of Human Subjects [Part 2] 45 mins V1.0
ELM-914 ICH E6 – Sponsor (Chapter 5) (R2) 15 mins V1.0
ELM-915 ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2) 15 mins V1.0
ELM-916 ICH E6 – Investigator’s Brochure (Chapter 7) (R2) 15 mins V1.0
ELM-917 ICH E6 – Essential Documents (Chapter 8)(R2) 15 mins V1.0
ELM-918 Good Clinical Practices (GCP) – Warning Letter Trends 15 mins V1.1
ELM-920 The Fundamentals of Good Pharmacovigilance Practices (GVP) 20 mins V2.0
ELM-922 Good Pharmacovigilance Practices (GVP): Updates to the European Union GVP Guidelines 30 mins V1.1
ELM-924 ICH E6 – Institutional Review Board / Independent Ethics Committee (IRB/IEC) (Chapter 3) R2 30 mins V1.0
ELM-925 WHO Guidance on Good Clinical Laboratory Practices 15 mins V1.0
ELM-926 The Fundamentals of Good Clinical Practices (ICH E6 R2) 20 mins V1.3
ELM-927 ICH E8 Objectives, Fundamentals, and General Principles 15 mins V1.0
ELM-928 ICH E8 Section 3 – Designing Quality into Clinical Studies 15 mins 1.0
ELM-929 ICH E8 Section 4 – Drug Development Planning 15 mins v1.0
ELM-931 Annual GxP Refresher Training (2023) 15 mins V1.2
ELM-933 GVP Risk Management Systems 10 mins V1.0
ELM-934 GVP PSUR (Periodic Safety Update Reports) 15 mins V1.1
ELM-935 GVP Signal Management 15 mins V1.0
ELM-939 Quality and Pharmacovigilance Systems 15 mins V1.1
ELM-944 Good Manufacturing Practice Refresher Course 5 mins V1.1
ELM-945 Good Clinical Practice Refresher Course 5 mins V1.1
ELM-946 Good Laboratory Practice Refresher Course 3 mins V1.1
ELM-947 Good Pharmacovigilance Practice Refresher Course 5 mins V1.0
ELM-948 Good Distribution Practice Refresher Course 5 mins V1.0
ELM-949 GxP Hot Topics: Cybersecurity Refresher Course 5 mins V1.0
ELM-950 Good Documentation Practice Refresher Course 5 mins V1.0
ELM-951 Data Integrity Refresher Course 5 mins V1.0
ELM-960 Recalls and Consent Decrees 20 mins 1.0
ELM-961 Regulatory Submissions 15 mins V1.0

Microlearnings

Code Title Duration
MLV-001 What are Good Manufacturing Practices (GMP)? 1 min
MLV-002 Why Is GMP Compliance So Important ? 1 min
MLV-003 The Principles of Production Operations in a GMP Environment 1 min
MLV-004 Why Good Documentation Practices are Critical in a GMP Environment 1 min
MLV-005 The General Rules of Good Documentation Practices & Data Integrity 1 min
MLV-006 Good Documentation Practices – Date Format 1 min
MLV-007 Good Documentation Practices – Time Format 1 min
MLV-008 Good Documentation Practices – Signatures 1 min
MLV-009 Good Documentation Practices – Scrap Paper and Post-Its 1 min
MLV-010 Good Documentation Practices – How to Make Corrections 1 min
MLV-011 Jim the Horse Tetanus Scandal 3 mins
MLV-012 2005 Able Laboratories Scandal 1 min
MLV-013 1930 – Lubeck BCG Vaccine 1 min
MLV-014 1938 – Sulfanilamide, the Elixir of Death 3 mins
MLV-015 1955 – The Polio Vaccine – The Cutter Incident 3 mins
MLV-016 What is Drug Contamination? 1 min
MLV-017 What is Drug Cross Contamination? 1 min
MLV-018 The Importance of Contamination Control 1 min
MLV-019 The Four Main Sources of Pharmaceutical Contamination 3 mins
MLV-020 What are Deviations? 1 min
MLV-021 Why are Regulatory Inspections So Critical? 1 min
MLV-022 What are Good Laboratory Practices (GLP)? 1 min
MLV-023 What are CAPA’s? 1 min
MLV-024 What is Quality Risk Management (QRM)? 1 min
MLV-025 What is the Difference Between Qualification and Validation? 1 min
MLV-026 Top 10 Principles of Good Manufacturing Practices (cGMP) 1 min
MLV-027 Requirements for All Staff in an Aseptic / GMP Environment 1 min
MLV-028 Clothing Requirements for Grades A/B, C and D 1 min
MLV-029 What Indirect Activities Does GMP Cover? 1 min
MLV-030 Why Personnel are Key in a GMP Manufacturing Environment 1 min
MLV-031 The Devastating Effects of the Thalidomide Tragedy [Video] 1 min
MLV-032 5 Key Elements of Good Manufacturing Practices 1 min
MLV-033 Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video] 1 min
MLV-034 10 Best Practices for Creating Solid User Requirements 3 mins
MLV-035 How the FDA Defines a Combination Product 1 min
MLV-036 The Power of Embracing Deviations in the Life Science Industry 1 min
MLV-037 The Importance of Quality Culture in the Life Sciences Industry 1 min
MLV-038 The Importance of Speaking Up in the Life Sciences Industry 1 min
MLV-039 The Crucial Role of Senior Leaders in Fostering a Quality Culture 3 mins
MLV-040 Ignoring Issues and the Repercussions That Can Follow 1 min
MLV-041 Creating a Speak-Up Culture: The Vital Role of Managers in Fostering Openness in the Life Science Industry 1 min
MLV-042 Putting Patients First: The Power of Speaking Up for Patient Safety 1 min
MLV-043 How Speaking Up Safeguards Compliance in the Life Science Industry 1 min
MLV-044 The Collective Responsibility of Data Integrity in the Life Science Industry 1 min
MLV-045 The Positive Impact of Raising Concerns From the Shop Floor 1 min
MLV-046 Access Control 1 min
MLV-047 Clean Work Surfaces 1 min
MLV-048 Cleaning vs. Disinfecting 1 min
MLV-049 The Importance of Environmental Monitoring 1 min
MLV-050 The Significance of Proper Gowning 1 min
MLV-051 The Importance of Proper Hygiene 1 min
MLV-052 The Synergy Between Ethical Standards and Quality Culture 1 min
MLV-053 Maintaining Quality Culture in a Rapidly Changing Industry 1 min
MLV-054 Aligning Success KPIs and Quality Culture 1 min
MLV-055 Quality Culture In Lean Teams 3 mins
MLV-056 Quality Culture and Continuous Improvement 1 min
MLV-057 The Difference Between Audits and Inspections 3 mins
MLV-058 How Self-Inspection Leads to Continuous Improvement 3 mins
MLV-059 What Does It Mean To Be Inspection Ready? 2 mins
MLV-060 How to Act When an Inspector is On Site 2 mins
MLV-061 Types of GMP Inspections (PAI, Routine, For Cause) 3 mins
MLV-062 Responding to Open-Ended Questions 2 mins
MLV-063 Inspector Interviews: Do’s and Don’ts 3 mins
MLV-064 Inspector Interviews: Body Language 2 mins
MLV-065 Impact of Deviations on Product Quality 3 mins
MLV-066 Deviations and Process Improvements 2 mins
MLV-067 Importance of Deviation Investigations 2 mins

Curriculum

Steps Title Duration
6 Steps GVP Onboarding -
9 Steps Document Control -
14 Steps GCP Investigator -
11 Steps GCP Sponsor -
4 Steps GMP CAPAs -
9 Steps GMP Deviations -
8 Steps Change Control -
13 Steps Computer System Validation (CSV & CSA) -
8 Steps ICH E6 Good Clinical Practices -
5 Steps Risk Management -
9 Steps Data Integrity -
5 Steps GDP Onboarding -
6 Steps GLP Onboarding -
10 Steps Inspection Readiness -
20 Steps Contamination Control -
43 Steps Contract Manufacturing (CDMOs & Generics) -
26 Steps Virtual Manufacturing (GCP) -
24 Steps Virtual Manufacturing (GMP) -
23 Steps GMP Biotech Manufacturing -
18 Steps GxP Leadership -
17 Steps GMP Onboarding -
15 Steps GxP New Hire -
15 Steps Quality Management Systems -