Training Catalog
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Featured accredited microlearning videos
Good Manufacturing Practices (cGMP) - Beginner
Why are Regulatory Inspections So Critical?
Good Manufacturing Practices (cGMP) - Beginner
The Four Main Sources of Pharmaceutical Contamination
Good Manufacturing Practices (cGMP) - Beginner
1955 – The Polio Vaccine – The Cutter Incident
Good Documentation Practices (GDocP)
Good Documentation Practices – How to Make Corrections
Good Documentation Practices (GDocP)
Good Documentation Practices – Scrap Paper and Post-Its
Good Documentation Practices (GDocP)
Why Good Documentation Practices are Critical in a GMP Environment
Good Manufacturing Practices (cGMP) - Beginner
The Principles of Production Operations in a GMP Environment
Good Manufacturing Practices (cGMP) - Beginner
What are Good Manufacturing Practices (GMP)?
Good Pharmacovigilance Practices (GVP)
5 Key Organizations in Global Pharmacovigilance Programs
Course Code: ELM-921
Good Documentation Practices (GDocP)
The General Rules of Good Documentation Practices & Data Integrity
FDA Inspection Readiness (GMP Auditing)
Why Are Regulatory Inspections So Critical?
Course Code: ELM-190
Good Pharmacovigilance Practices (GVP)
Changes in Pharmacovigilance: Brexit Transition
Course Code: ELM-922
Good Manufacturing Practices (cGMP) - Beginner
The FDA’s Role in Pharmaceutical Regulation
Course Code: ELM-722
Good Manufacturing Practices (cGMP) - Beginner
The Harsh Reality of Injectable Cosmetic Treatments
Course Code: ELM-710
Good Manufacturing Practices (cGMP) - Beginner
Do You Remember the Devastating Effects of the Polio Vaccine?
Course Code: ELM-710
Equipment Qualification
The 3 Parameters to Consider During Any Risk Analysis Process
Course Code: ELM-182
Good Laboratory Practices (cGLP)
Which FDA Regulations Apply to Laboratory Practices?
Course Code: ELM-101
CSV - Intermediate
Factors Determining the Frequency of Periodic Reviews [Video]
Course Code: ELM-149A
CSV - Intermediate
The Difference Between Testing, Qualification and Validation [Video]
Course Code: ELM-165A
Medical Device Validation
Don’t Forget to Include Test Equipment in Your Validation Plan!
Course Code: ELM-164
Process Validation
The Difference Between Prospective, Concurrent and Retrospective Validation [Video]
Course Code: ELM-158
Change Control
The 3 Major Benefits of Change Control for Life Science Organizations
Course Code: ELM-159
Good Laboratory Practices (cGLP)
The US Regulatory Requirements for Laboratory Investigations [Video]
Course Code: ELM-174
CSV - Intermediate
The Roles and Responsibilities Your Validation Program Needs [Video]
Course Code: ELM-163
Good Clinical Practices (cGCP)
Waiving of Consent for Armed Force Members [Video]
Course Code: ELM-909
Good Clinical Practices (cGCP)
The 4 Times When Informed Consent is Not Required [Video]
Course Code: ELM-909
CSV - Beginner
The 5 Essential Definitions You Must Understand to Successfully Evaluate Risk [Video]
Course Code: ELM-162
Good Clinical Practices (cGCP)
Data Collected in Clinical Trials is Worthless without Data Integrity [Video]
Course Code: ELM-903
Process Validation
Your 1 Minute Guide to Design Qualification (DQ) with Examples [Video]
Course Code: ELM-158
Process Validation
Prospective, Concurrent & Retrospective Validation Explained in 3 Minutes [Video]
Course Code: ELM-158
Good Manufacturing Practices (cGMP) - Beginner
Top 10 Principles of Good Manufacturing Practices (cGMP) [Video]
Course Code: ELM-219
Process Validation
Software Cannot Be Pre-Validated – Understand Intended Use [Video]
Course Code: ELM-158
Process Validation
Top Tips for Creating a Bullet Proof Validation Protocol [Video]
Course Code: ELM-157
Process Validation
Explaining Validation Efficacy and Usability Using a Band-Aid [Video]
Course Code: ELM-157
MDSAP
Traceability of Design Outputs to Design Inputs a Key Task for MDSAP [Video]
Course Code: ELM-139
Good Manufacturing Practices (cGMP) - Beginner
Are Your Personnel Adhering to CFR 211.28 to Avoid Contamination? [Video]
Course Code: ELM-211
Process Validation
Understanding Validation and Verification Using a Life Preserver [Video]
Course Code: ELM-156
FDA Warning Letters
The FDA Training Regulations for Pharmaceutical and Medical Device Companies
Course Code: ELM-302
Good Manufacturing Practices (cGMP) - Beginner
Don’t Forget cGMP Training is a Regulatory Requirement! [Video]
Course Code: ELM-211
MDSAP
Auditing the Device Marketing Authorization and Facility Registration Process [MDSAP]
Course Code: ELM-138
Good Manufacturing Practices (cGMP) - Beginner
Your 60 Second Guide to Gang Printed Labelling [211.122]
Course Code: ELM-209
Data Integrity (ALCOA)
The 4 Times When Transcribing Data is Acceptable – GDP [Video]
Course Code: ELM-153
Data Integrity (ALCOA)
The GDP Issues That Got Zhejiang Pharma an FDA Warning Letter [Video]
Course Code: ELM-153
Good Manufacturing Practices (cGMP) - Beginner
What the FDA Expects for Equipment Design, Size, and Location (Sect. 211.63) [Video]
Course Code: ELM-212
Contamination Control & Aseptic Techniques
How to Visually Inspect a RABS Glove [Video]
Course Code: ELM-708
21 CFR Part 820
The Procedure for a Successful Shipping Validation (Sec 820.120/130) [Video]
Course Code: ELM-311
ISO 13485:2016
How a Turtle Can Help Your Audit Process – ISO 13485:2016 [Video]
Course Code: ELM-805
21 CFR Part 820
Your 1 Minute Guide to Labeling and Packaging Control – Sec 820.120/130 [Video]
Course Code: ELM-311
Data Integrity (ALCOA)
Unintentional Vs Intentional Data Integrity Mistakes [Video]
Course Code: ELM-148
Data Integrity (ALCOA)
7 Regulator Enforcement Actions as a Result of Data Integrity Issues [Video]
Course Code: ELM-148
Data Integrity (ALCOA)
Catastrophic Example of a Data Integrity Issue within the Automotive Industry [Video]
Course Code: ELM-148
Data Integrity (ALCOA)
Catastrophic Example of a Data Integrity Issue within the Life Sciences
Course Code: ELM-148
21 CFR Part 820
Your 1 Minute Guide to Design Verification – Sec 820.30 (f) [Video]
Course Code: ELM-303
ISO 13485:2016
ISO 13485:2016 Process Requirements for Product Non-Conformance’s [Video]
Course Code: ELM-808
21 CFR Part 820
How to Avoid FDA Process Validation Warning Letters (21 CFR 820.75)
Course Code: ELM-209
Contamination Control & Aseptic Techniques
Safely Applying and Removing (Donning and Doffing) PPE – CDC Best Practice
Contamination Control & Aseptic Techniques
How to Avoid FDA Microbial Contamination Warning Letters (21 CFR 211.113(b)) [Video]
Contamination Control & Aseptic Techniques
Returning to Work in a GMP Environment After Coronavirus
21 CFR Part 820
How to Avoid FDA Design Validation Warning Letters (21 CFR Part 820.30(g)) [Video]
Course Code: ELM-303
21 CFR Part 11
How to Avoid FDA Data Integrity System Access Warning Letters (21 CFR Part 11) [Video]
Course Code: ELM-114
21 CFR Part 820
How to Avoid FDA Design Change Warning Letters (21 CFR Part 820.30(i)) [Video]
Course Code: ELM-303
FDA Warning Letters
How to Avoid FDA Laboratory Records Warning Letter (21 CFR 211.194(a)) [Video]
Course Code: ELM-210
21 CFR Part 820
How to Avoid a FDA Quality Audit Warning Letter (21 CFR Part 820.22) [Video]
Course Code: ELM-302
21 CFR Part 820
CAPA – The Most Important Aspect of the QMS – Sec 820.100 [Video]
Course Code: ELM-310
Good Manufacturing Practices (cGMP) - Beginner
Your 1 Minute Guide to the Maintenance and Storage of Drug Labeling and Packaging – 21 CFR Part 211.22(c-d) [Video]
Course Code: ELM-209
21 CFR Part 820
How to Perform a Risk Assessment of Your Suppliers – Sec 820.50 (a)(1) [Video]
Course Code: ELM-305
21 CFR Part 820
Purchasing Controls for Medical Device Companies (21 CFR Part 820.50) [Video]
Course Code: ELM-305
Good Manufacturing Practices (cGMP) - Beginner
Your 1 Minute Recap of Equipment Cleaning and Use Log (Sect. 211.182)
Course Code: ELM-210
Good Manufacturing Practices (cGMP) - Beginner
Charge of Component and Preserving the Active Ingredient (Part 211.101) [Video]
Course Code: ELM-208
Contamination Control & Aseptic Techniques
How to Reduce the Spread of the Coronavirus [Video]
ISO 13485:2016
Actions in Response to Nonconforming Product Detected Before Delivery
Course Code: ELM-808
Contamination Control & Aseptic Techniques
6 Top Tips – Preventing the Spread of Coronavirus (COVID-19)
21 CFR Part 820
Do You Know the Various Time Points for Stability Studies? [Video]
Course Code: ELM-311
Contamination Control & Aseptic Techniques
Contamination in a GMP Environment Leads to FDA Warning Letters!
Course Code: ELM-105
Contamination Control & Aseptic Techniques
Personnel: The Biggest Potential Source of Contamination in a GMP Environment
Course Code: ELM-105
Contamination Control & Aseptic Techniques
The Causes of Drug Cross-Contamination in a GMP Environment [Video]
Course Code: ELM-705
Contamination Control & Aseptic Techniques
What is Drug Contamination in a GMP Environment [Video]
Course Code: ELM-105
Good Documentation Practices (GDocP)
Backdating Will Get You a Warning Letter from the FDA Really Quickly!
Course Code: ELM-104
Good Documentation Practices (GDocP)
Why Does Everyone Struggle with Good Documentation Practices?
Course Code: ELM-104
MDSAP
Sterile Medical Device Requirements – Ensure Sterility is Preserved! [Video]
Course Code: ELM-136
ISO 13485:2016
ISO 13485:2016 – Keep the Quality Agreement Separate to the Supplier Agreement [Video]
Course Code: ELM-806
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: ‘Damage Control’ and Containment
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Understanding the Problem
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Prioritizing Based on Risk
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
Sources of Corrective and Preventative Actions
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics | Process Requirements: ISO 13485
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics | Process Requirements: FDA
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Process Requirements Overview
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Industry Non-Compliance
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA | Systemic Issues: Process Examples
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA | Systemic Issues: Product Examples
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Non-Systemic Issues
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Preventative Action
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
Pitfalls of Not Understanding the CAPA Process
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
The Role of Regulations in a CAPA System
Course Code: ELM-117
Good Documentation Practices (GDocP)
Company Supporting Procedures Pertaining to Logbooks
Course Code: ELM-104
Good Documentation Practices (GDocP)
GDocP: Making Multiple Corrections on a Document
Course Code: ELM-502
Good Documentation Practices (GDocP)
The Importance of a Signature Specimen File
Course Code: ELM-104
Good Documentation Practices (GDocP)
Documents to Which Good Documentations Practices Should Be Applied
Course Code: ELM-104
Good Documentation Practices (GDocP)
What Are Good Documentation Practices (GDocP)?
Course Code: ELM-104
ISO 13485:2016
The Importance of Allowing Adequate Time for Design and Development Inputs | ISO 13485
Course Code: ELM-805
ISO 13485:2016
“Awareness” and the Achievement of Quality Objectives | ISO 13485
Course Code: ELM-804
ISO 13485:2016
How Key Process Indicators (KPIs) Ensure Adequate Resources | ISO 13485
Course Code: ELM-804
ISO 13485:2016
Top Management Must Address Customer Requirements and Issues | ISO 13485
Course Code: ELM-803
Contamination Control & Aseptic Techniques
Acceptance Criteria for Non-Sterile Pharmaceutical Products
Course Code: ELM-706
Contamination Control & Aseptic Techniques
Microbial Enumeration Test (MET) Explained
Course Code: ELM-706
Contamination Control & Aseptic Techniques
Microbiological Culture Media Explained
Course Code: ELM-706
Contamination Control & Aseptic Techniques
Consequences of Microbial Contamination in Medicinal Products
Course Code: ELM-705
Contamination Control & Aseptic Techniques
GMP Essentials: Pharmaceutical Microbiology Defined
Course Code: ELM-705
Contamination Control & Aseptic Techniques
Factors Affecting Microbial Spoilage of Pharmaceutical Products
Course Code: ELM-705
Good Clinical Practices (cGCP)
Major Responsibilities of the Institutional Review Board (IRB)
Course Code: ELM-901
FDA Inspection Readiness (GMP Auditing)
Key Principles of GMP Audits for Auditors
Course Code: ELM-122
FDA Inspection Readiness (GMP Auditing)
Anatomy of an Internal Audit (Self Inspection)
Course Code: ELM-122
Good Manufacturing Practices (cGMP) - Beginner
GMP Lessons Learned from the 1962 Thalidomide Disaster [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
The International Conference on Harmonization (ICH) Explained [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
GMP Lessons Learned from the Cutter Labs Polio Vaccine Incident [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
The Good Manufacturing Practice Concept: Pharmaceutical Industry [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
The ‘Elixir of Death’ Tragedy Led to Establishing the USFDA [Video]
Course Code: ELM-103
Data Integrity (ALCOA)
The Importance of Making Records Legible and Understandable [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
The Importance of Audit Trails to Laboratory Data Integrity [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
Basics of Assuring the Integrity of Electronic Records [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
How Analyzing ‘Unofficial’, ‘Trial’ or ‘Demo’ Samples Undermines Laboratory Data Integrity [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
How Analytical Processes can be Manipulated to Compromise Final Reports [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
The Consequences of Unreliable Data for YOUR Organization – Part 2 [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
The Consequences of Unreliable Data for YOUR Organization – Part 1 [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
The Catastrophic Consequences of Unreliable Data for the Patient [Video]
Course Code: ELM-102
Good Laboratory Practices (cGLP)
14 Requirements to Ensure Good Quality Control in a Laboratory [Video]
Course Code: ELM-101
Good Laboratory Practices (cGLP)
The 11 Fundamentals of Good Laboratory Practices (cGLP) [Video]
Course Code: ELM-101
Good Laboratory Practices (cGLP)
Good Laboratory Practices – Regulations & Standards [Video]
Course Code: ELM-101
Good Laboratory Practices (cGLP)
Top 6 Benefits of Good Laboratory Practices [Video]
Course Code: ELM-101
Good Laboratory Practices (cGLP)
The Principles of Good Laboratory Practices [Video]
Course Code: ELM-101
Good Manufacturing Practices (cGMP) - Beginner
What is Quality Management? [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
GMP Lessons Learned from the Contaminated Caps – Lambert Tragedy [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
GMP Lessons Learned from the Lubeck – BCG Vaccine Tragedy [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
Why GMP is Critical to Patient Safety [Video]
Course Code: ELM-219
CSV - Beginner
Change Management is Essential to Maintaining a Validated State [Video]
Course Code: ELM-133
Good Manufacturing Practices (cGMP) - Beginner
The Importance of Personal Hygiene in a GMP Environment [Video]
Course Code: ELM-202
Good Manufacturing Practices (cGMP) - Beginner
Personnel – The Most Critical Aspect of Any GMP Process [Video]
Course Code: ELM-202
Good Manufacturing Practices (cGMP) - Beginner
The Importance of Storage Areas in a GMP Environment [Video]
Course Code: ELM-202
Good Manufacturing Practices (cGMP) - Beginner
Why GMP Production Should Be Performed by Qualified People [Video]
Course Code: ELM-103
ISO 13485:2016
1 Minute Guide to Design Input Requirements – ISO 13485:2016 [Video]
Course Code: ELM-805
Good Manufacturing Practices (cGMP) - Beginner
The Importance of Changing Rooms in a GMP Environment [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
The 4 Critical Aspects of GMP in Sterile Production Areas [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
The Importance of GMP as a Part of Quality Assurance [Video]
Course Code: ELM-103
Good Manufacturing Practices (cGMP) - Beginner
Why Personnel are Key in a GMP Manufacturing Environment [Video]
Course Code: ELM-219
CSV - Beginner
Why Change Management is Critical to Software Validation (CSV) [Video]
Course Code: ELM-134
Contamination Control & Aseptic Techniques
The Main Risks of Glove Damage Inside an Isolator [Video]
Course Code: ELM-707
Contamination Control & Aseptic Techniques
Why the Integrity of Gloves and Sleeves is Critical when Using Isolators [Video]
Course Code: ELM-707
Contamination Control & Aseptic Techniques
The Reason Why Sterility Testing is Critical [Video]
Course Code: ELM-707
Contamination Control & Aseptic Techniques
Regulatory Expectations in Aseptic Processing for Sterile Drug Product [Video]
Course Code: ELM-707
Good Laboratory Practices (cGLP)
Why The FDA Shut Down Able Laboratories – 5 Data Integrity Issues [Video]
Course Code: ELM-102
Good Manufacturing Practices (cGMP) - Beginner
What Indirect Activities Does GMP Cover? [Video]
Course Code: ELM-219
Contamination Control & Aseptic Techniques
Where Does Pharmaceutical Contamination Come From? [Video]
Course Code: ELM-105
Good Documentation Practices (GDocP)
The 6 Essential Stages of a Standard Operating Procedure (SOP) Life Cycle [Video]
Course Code: ELM-126
Good Manufacturing Practices (cGMP) - Beginner
The Devastating Effects of the Thalidomide Tragedy [Video]
Course Code: ELM-219
Contamination Control & Aseptic Techniques
Top 5 Factors to Consider When Designing a Cleaning Process [Video]
Course Code: ELM-705
Contamination Control & Aseptic Techniques
Top 5 Factors Affecting Microbial Spoilage of Pharmaceutical Products [Video]
Course Code: ELM-704
Good Manufacturing Practices (cGMP) - Beginner
Clothing Requirements for Grades A/B, C and D [Video]
Course Code: ELM-219
Good Manufacturing Practices (cGMP) - Beginner
Requirements for All Staff in an Aseptic / GMP Environment [Video]
Course Code: ELM-219
21 CFR Part 11
Your 1 Minute Guide to Key Regulations Associated with Computer Systems [Video]
Course Code: ELM-125
21 CFR Part 820
Your 1 Minute Guide to Document Revision in a Regulated Environment [Video]
Course Code: ELM-304
21 CFR Part 820
How the Document Hierarchy Works in a Life Science Environment – With Example [Video]
Course Code: ELM-304
21 CFR Part 11
The Difference Between Data Backup, Recovery, Archiving and Disaster Recovery [Video]
Course Code: ELM-114
Good Clinical Practices (cGCP)
The Informed Consent Process for Clinical Trials [Video]
Course Code: ELM-901
Good Clinical Practices (cGCP)
The Meaning of Informed Consent for Clinical Trials [Video]
Course Code: ELM-901
Good Clinical Practices (cGCP)
What is an Institutional Review Board (IRB/IEC)? [Video]
Course Code: ELM-901
Good Clinical Practices (cGCP)
What are Good Clinical Practices (cGCP) ? [Video]
Course Code: ELM-901
21 CFR Part 820
The Reason Why Organizations Resist Approving Design Documents [Video]
Course Code: ELM-805
21 CFR Part 11
Your 1 Minute Guide to the Protection of Records – 21 CFR Part 11.10(c) [Video]
Course Code: ELM-115
21 CFR Part 820
ISO 13485:2016: The Biggest Mistake to Avoid with Dealing with Design Controls [Video]
Course Code: ELM-805
21 CFR Part 820
Medical Device Production and the Importance of the Quality Plan [Video]
Course Code: ELM-805
Good Manufacturing Practices (cGMP) - Beginner
Why Process Validation is Reliant on a Detailed Design Review of the Product [Video]
Course Code: ELM-401
CSV - Beginner
The 6 Quality Attributes Required to Create Solid User Requirements [Video]
Course Code: ELM-134
CSV - Beginner
Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
Course Code: ELM-152
Contamination Control & Aseptic Techniques
The 6 Key Sources of Microbial Contamination in a GMP Environment [Video]
Course Code: ELM-705
21 CFR Part 11
Software Configuration in a Regulated Environment – 1 Minute Guide [Video]
Course Code: ELM-133
21 CFR Part 820
The Main Deliverables of a Validation Master Plan (VMP) [Video]
Course Code: ELM-804
21 CFR Part 11
GAMP®5 Roles and Responsibilities Simplified – Process Owner [Video]
Course Code: ELM-132
FDA Inspection Readiness (GMP Auditing)
11 Key Items to Consider When Conducting a Vendor Audit [Video]
Course Code: ELM-127
21 CFR Part 820
All You Need to Know About Quality Policies – ISO 13485 : 2016 [Video]
Course Code: ELM-803
CSV - Beginner
The 6 Fundamentals of a Solid User Requirement Specification (URS) [Video]
Course Code: ELM-127
Data Integrity (ALCOA)
Consequences of Non-Compliance for Regulated Laboratories [Video]
Course Code: ELM-101
21 CFR Part 11
How to Protect Your Electronic Records and Comply with 21 CFR Part 11 [Video]
Course Code: ELM-114
FDA Inspection Readiness (GMP Auditing)
The Difference Between Horizontal & Vertical Auditing [Video]
Course Code: ELM-122
CSV - Beginner
The Difference Between the Waterfall and Agile Approach to Software Development [Video]
Course Code: ELM-133
21 CFR Part 11
7 Key Principles of GAMP®5 for Computer System Validation [Video]
Course Code: ELM-133
Good Documentation Practices (GDocP)
Your 1 Minute Guide to Closing Deviations Successfully [Video]
Course Code: ELM-131
Process Validation
The 3 Phases of Process Validation to Ensure Quality, Safety & Efficacy [Video]
Course Code: ELM-402
Good Laboratory Practices (cGLP)
6 Key Requirements of a Cleaning Process SOP [Video]
Course Code: ELM-601
CSV - Beginner
4 Questions You Need to Ask to Ensure a Deviation is NOT Repeated [Video]
Course Code: ELM-131
CSV - Beginner
The Life Cycle of a Deviation Explained with Industry Example [Video]
Course Code: ELM-131
Good Documentation Practices (GDocP)
5 Tips to Help You Write Better Deviation Descriptions [Video]
Course Code: ELM-129
FDA Inspection Readiness (GMP Auditing)
The 5 Main Objectives of a GMP Audit and Defining Your Role [Video]
Course Code: ELM-122
21 CFR Part 820
Your 1 Minute Guide to Incoming Material Inspection – 21 CFR Part 820.80(b) [Video]
Course Code: ELM-308
Good Manufacturing Practices (cGMP) - Beginner
Your 1 Minute Guide to Acceptance / Carryover Limits for Cleaning Validation [Video]
Course Code: ELM-601
Good Laboratory Practices (cGLP)
The 3 Risk Classifications for Equipment in a Regulated Environment [Video]
Course Code: ELM-121
21 CFR Part 820
Your 1 Minute Guide to Line Clearance in a GMP Production Environment [Video]
Course Code: ELM-307
FDA Inspection Readiness (GMP Auditing)
9 Areas the FDA Focus on When Inspecting Laboratory Instrumentation [Video]
Course Code: ELM-106
Good Manufacturing Practices (cGMP) - Beginner
How to Stop Risky Behaviors in a GMP Environment [Video]
21 CFR Part 820
Your 2 Minute Guide to Specification, Alert and Action Limits – 820.70(a) [Video]
Course Code: ELM-307
CSV - Beginner
Screenshot Management When Executing Software Validation Protocols [Video]
Course Code: ELM-111
FDA Inspection Readiness (GMP Auditing)
11 Top Tips to Help You Write Better GMP Audit Reports [Video]
Course Code: ELM-122
FDA Inspection Readiness (GMP Auditing)
10 Documents You Must Review When Conducting a GMP Audit [Video]
Course Code: ELM-122
Good Manufacturing Practices (cGMP) - Beginner
9 Ways to Improve the GMP/Quality Culture in Your Organization [Video]
Good Manufacturing Practices (cGMP) - Beginner
How At Risk Quality Behaviors Can Lead to Major Product Recalls [Video]
Good Manufacturing Practices (cGMP) - Beginner
Maximum Allowable Carryover (MAC or MACO) in a Nutshell [Video]
Course Code: ELM-601
Good Documentation Practices (GDocP)
Essential Documentation for a Factory Acceptance Test (FAT) [Video]
Course Code: ELM-121
21 CFR Part 820
Your Two Minute Guide to Unique Device Identification (UDI) [Video]
Course Code: ELM-307
Good Manufacturing Practices (cGMP) - Beginner
Your 2 Minute Guide to Swab Sampling [Video]
Course Code: ELM-601
Good Manufacturing Practices (cGMP) - Beginner
The Difference Between Clean and Dirty Hold Times [Video]
Course Code: ELM-601
Process Validation
Traditional Vs Modern Approach to Process Validation [Video]
Course Code: ELM-402
Good Documentation Practices (GDocP)
How to Report Laboratory Test Results Correctly [Video]
Course Code: ELM-109
21 CFR Part 11
The 3 Main User Authentication Methods for 21 CFR Part 11 [Video]
Course Code: ELM-115
FDA Inspection Readiness (GMP Auditing)
6 Key Areas for the FDA Audit for Process Validation [Video]
Course Code: ELM-401
21 CFR Part 820
Your 2-Minute Guide to Design Outputs and Reviews (820.30) [Video]
Course Code: ELM-303
CSV - Beginner
Top Tips When Retesting Software in a Regulated Environment [Video]
Course Code: ELM-119
Good Laboratory Practices (cGLP)
8 Actions You Need to Take To Successfully Close Out a CAPA [Video]
Course Code: ELM-117
Good Laboratory Practices (cGLP)
8 Process Requirements the FDA Want in Your CAPA System [Video]
Course Code: ELM-117
21 CFR Part 820
9 Essential Items Your Change Control Process Must Include [Video]
Course Code: ELM-303
FDA Inspection Readiness (GMP Auditing)
5 Things You Need to Know About Meaningful Laboratory Investigations [Video]
Course Code: ELM-108
Good Laboratory Practices (cGLP)
Your 2 Minute Guide to Sampling in a Quality Control Laboratory [Video]
Course Code: ELM-109
21 CFR Part 11
8 Essential Tips to Prevent Unauthorized System Access – 21 CFR Part 11 [Video]
Course Code: ELM-115
21 CFR Part 11
7 Top Tips for Validating Computer Systems in a Regulated Environment [Video]
Course Code: ELM-114
Good Laboratory Practices (cGLP)
The 9 Golden Rules – Ensuring Laboratory Data Integrity [Video]
Course Code: ELM-102
21 CFR Part 820
The Similarity Between Device Master Records & Chocolate Chip Cookies [Video]
Course Code: ELM-303
FDA Inspection Readiness (GMP Auditing)
The Four Phases of Conducting a Laboratory Investigation [Video]
Course Code: ELM-108
Good Manufacturing Practices (cGMP) - Beginner
The Difference Between Qualification and Validation [Video]
Course Code: ELM-203
Good Manufacturing Practices (cGMP) - Beginner
International Conference on Harmonization (ICH) in a Nutshell [Video]
Course Code: ELM-103
Contamination Control & Aseptic Techniques
Main Types of Personnel Contamination in a GMP Manufacturing Environment [Video]
Course Code: ELM-704
Contamination Control & Aseptic Techniques
The Four Type of Contaminants Found in a Cleanroom [Video]
Course Code: ELM-704
Good Manufacturing Practices (cGMP) - Beginner
Implement a New System But Don’t Train Your Employees…Here’s Your 483!
FDA Inspection Readiness (GMP Auditing)
Rounding of Numbers and the Tie Break Rule – Essential for Laboratory Analysis
Course Code: ELM-109
Good Laboratory Practices (cGLP)
Laboratory Investigations and the Importance of the Barr Decision (Part 211.192) [Video]
Course Code: ELM-108
Contamination Control & Aseptic Techniques
Considerations of Sterile Filtration Validation: 21 CFR 211.113 (b)
Course Code: ELM-121
Good Documentation Practices (GDocP)
The Three Levels of Training Required for Deviation Handling
CSV - Beginner
How to Identify Suppliers and Determine Their Effect on Quality (Video)
Course Code: ELM-107
Good Manufacturing Practices (cGMP) - Beginner
Product Life Cycle Management for Pharmaceutical & Biotechnology Products – Part 2
Good Manufacturing Practices (cGMP) - Beginner
Product Lifecycle Management for Pharmaceutical & Biotechnology Products – Part 1
Good Manufacturing Practices (cGMP) - Beginner
Why Changes to Equipment and Documentation Play a Vital Role in GMP
Good Manufacturing Practices (cGMP) - Beginner
An Introduction to Correction and Preventive Actions (CAPA)
Good Manufacturing Practices (cGMP) - Beginner
Potential Areas Of Use For Risk Management Tools
Good Manufacturing Practices (cGMP) - Beginner
Building Management System (BMS) – Validation Overview
Contamination Control & Aseptic Techniques
The Main Sources of Contamination in the Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
An Introduction to Behavior Based Quality – Part 3
Good Manufacturing Practices (cGMP) - Beginner
How to Select the Right Projects to Execute
Good Manufacturing Practices (cGMP) - Beginner
Cleaning Validation: The Critical Steps Involved
Process Validation
Calibration, Validation and Verification, They Are Different You Know!
Good Manufacturing Practices (cGMP) - Beginner
How Well-Designed Weighing Processes Improve Quality
Good Manufacturing Practices (cGMP) - Beginner
Top Tips – Component Procurement for a Purified Water Treatment System
Good Manufacturing Practices (cGMP) - Beginner
Water Purification Treatment Supplier Audits
Good Manufacturing Practices (cGMP) - Beginner
Top Tips for Facility Design, Layout and Equipment Handling
Good Laboratory Practices (cGLP)
How Laboratory Testing should be Performed in a Quality Regulated Environment
Good Laboratory Practices (cGLP)
Equipment Qualification for Analytical Laboratory Instruments
Contamination Control & Aseptic Techniques
Prevention and Control of Microbial Contamination For Pharmaceutical Products
Good Manufacturing Practices (cGMP) - Beginner
Guide to FDA Approval Process and Importance of Equipment Calibration
Good Manufacturing Practices (cGMP) - Beginner
Top 9 Tips for Successful Implementation of FMEA
Good Laboratory Practices (cGLP)
The Purpose of a Laboratory Quality Assurance Program (QAP)
CSV - Beginner
How to Create a Bullet-Proof User Requirement Specification (URS)
Course Code: ELM-127
Good Manufacturing Practices (cGMP) - Beginner
Root Cause Identification & Role of Risk Management
Good Manufacturing Practices (cGMP) - Beginner
The Fundamentals of Project Delivery in the Life Sciences
Good Laboratory Practices (cGLP)
Controlling Chromatographic Integration in a Regulated or Accredited Laboratory
FDA Inspection Readiness (GMP Auditing)
cGMP Compliance Audit: 5 Questions You Should Ask Yourself
Good Manufacturing Practices (cGMP) - Beginner
Are You Moaning About Cleaning Validation?
Good Laboratory Practices (cGLP)
The Application of FMEA to Laboratory Instrument Qualification Risk Management – Part 2
Good Laboratory Practices (cGLP)
The Application of FMEA to Laboratory Instrument Qualification Risk Management – Part 1
Good Manufacturing Practices (cGMP) - Beginner
Quality Risk Management within the Pharmaceutical Industry
FDA Inspection Readiness (GMP Auditing)
12 Common Audit Findings Associated with Equipment Qualifications
FDA Inspection Readiness (GMP Auditing)
Top 12 Audit Findings for Equipment Systems within a Regulated Environment
Good Manufacturing Practices (cGMP) - Beginner
Top 10 Concerns Associated with Clinical Trials
FDA Inspection Readiness (GMP Auditing)
Top Tips On How To Investigate Laboratory & Manfacturing Sterility Failures
Good Manufacturing Practices (cGMP) - Beginner
Top 22 Reasons Why Risk Assessments are So Difficult?
Good Manufacturing Practices (cGMP) - Beginner
Technology Trends Facing Life Sciences in 2013
Good Manufacturing Practices (cGMP) - Beginner
Showing Insufficient Deviations to Support Comprehensive Testing
Good Manufacturing Practices (cGMP) - Beginner
Supplier Qualification – All You Need To Know
Course Code: ELM-107
Good Manufacturing Practices (cGMP) - Beginner
Quality Agreements: The Essential Items for Contract Manufacturers
Good Manufacturing Practices (cGMP) - Beginner
Environmental Management Issues in the Pharmaceutical Industry: A Review
Good Manufacturing Practices (cGMP) - Beginner
Challenges and Factors Affecting Production Planning and Control in Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
Challenges in Pharmaceutical Product Life Cycle Management
Good Manufacturing Practices (cGMP) - Beginner
The Ultimate API Cleaning Validation Protocol
Good Manufacturing Practices (cGMP) - Beginner
Operations and Scheduling Aspects of Flexible Manufacturing Systems
Good Manufacturing Practices (cGMP) - Beginner
Levels Of Flexibilities In Flexible Manufacturing Systems
Good Manufacturing Practices (cGMP) - Beginner
Outsourcing Challenges and Strategies For Pharmaceutical Manufacturers
Good Manufacturing Practices (cGMP) - Beginner
Manufacturing Engineering Systems And The Challenges
Good Manufacturing Practices (cGMP) - Beginner
The 3 C’s: Impact on Vendor Qualifications in Bio-Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
Constituents And Factors Of Technology Transfer In Pharmaceutical Industry
Contamination Control & Aseptic Techniques
Prevention Of Contamination And Cross – Contamination In Pharmaceutical Dosage Forms
Good Manufacturing Practices (cGMP) - Beginner
Measuring, Controlling and Predicting Process Performance
Good Manufacturing Practices (cGMP) - Beginner
Scope Of Risk Management For The Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
Knapp Testing & Manual Inspection – What Do You Think?
Good Manufacturing Practices (cGMP) - Beginner
Optimizing Manufacturing Operations: Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
Concepts Of Industrial Manufacturing Techniques
Good Manufacturing Practices (cGMP) - Beginner
Pharmaceutical Excipient Factors Affecting Tablet Formulation And Regulatory Requirements
Good Manufacturing Practices (cGMP) - Beginner
Blend Uniformity in Pharmaceutical Solid Dosage Forms
Good Manufacturing Practices (cGMP) - Beginner
Operational Excellence and Process Evaluation In Pharmaceutical Manufacturing
Good Manufacturing Practices (cGMP) - Beginner
Cleaning In Place (CIP) Vs Cleaning Out of Place (COP)
Good Manufacturing Practices (cGMP) - Beginner
Process Robustness in Pharmaceutical Manufacturing
Good Documentation Practices (GDocP)
Good Documentation Practices (GDocP) are Critical to Success!
Good Manufacturing Practices (cGMP) - Beginner
Critical Parameters Affecting Process Validation
Good Manufacturing Practices (cGMP) - Beginner
Warehousing Mapping a Brief Guide to Success
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Manufacturing Execution Systems (MES) & Validation
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Water Generation and Distribution System Qualification Program
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