Training Catalog

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Featured accredited microlearning videos

Microlearnings
Access Control
Good Manufacturing Practices (cGMP) - Beginner
What are CAPA’s?
Good Laboratory Practices (cGLP)
What are Good Laboratory Practices (GLP)?
Good Manufacturing Practices (cGMP) - Beginner
Why are Regulatory Inspections So Critical?
Good Manufacturing Practices (cGMP) - Beginner
What are Deviations?
Good Manufacturing Practices (cGMP) - Beginner
The Four Main Sources of Pharmaceutical Contamination
Good Manufacturing Practices (cGMP) - Beginner
The Importance of Contamination Control
Good Manufacturing Practices (cGMP) - Beginner
What is Drug Cross Contamination?
Good Manufacturing Practices (cGMP) - Beginner
What is Drug Contamination?
Good Manufacturing Practices (cGMP) - Beginner
1955 – The Polio Vaccine – The Cutter Incident
Good Manufacturing Practices (cGMP) - Beginner
1938 – Sulfanilamide, the Elixir of Death
Good Manufacturing Practices (cGMP) - Beginner
1930 – Lubeck BCG Vaccine
Good Manufacturing Practices (cGMP) - Beginner
2005 Able Laboratories Scandal
Good Manufacturing Practices (cGMP) - Beginner
Jim the Horse Tetanus Scandal
Good Documentation Practices (GDocP)
Good Documentation Practices – Signatures
Good Documentation Practices (GDocP)
Good Documentation Practices – Time Format
Good Documentation Practices (GDocP)
Good Documentation Practices – Date Format
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)?
Fundamentals Series
Data Integrity in Action
Course Code: ELM-221
Data Integrity (ALCOA)
Why Is Data Integrity Compliance So Important?
Course Code: ELM-221
Good Pharmacovigilance Practices (GVP)
5 Key Organizations in Global Pharmacovigilance Programs
Course Code: ELM-921
Good Pharmacovigilance Practices (GVP)
Remote Inspections
Course Code: ELM-923
Good Pharmacovigilance Practices (GVP)
Pharmacovigilance Inspection Report
Course Code: ELM-923
Fundamentals Series
Good Documentation Practices in Action
Course Code: ELM-220
FDA Inspection Readiness (GMP Auditing)
Inspection Procedures
Course Code: ELM-190
FDA Inspection Readiness (GMP Auditing)
Why Are Regulatory Inspections So Critical?
Course Code: ELM-190
Microlearnings
Quality Risk Management, Defined
Course Code: ELM-232b
Microlearnings
Who is Accountable for QRM?
Course Code: ELM-232b
Good Pharmacovigilance Practices (GVP)
Changes in Pharmacovigilance: Brexit Transition
Course Code: ELM-922
Good Manufacturing Practices (cGMP) - Beginner
Why Is GMP Compliance So Important ?
Fundamentals Series
5 Key Elements of Good Manufacturing Practices
Course Code: ELM-219
CSV - Intermediate
What to Expect From a Quality Agreement
Course Code: ELM-166B
CSV - Intermediate
Why Validate?
Course Code: ELM-166B
Good Pharmacovigilance Practices (GVP)
What is Pharmacovigilance?
Course Code: ELM-920
Good Pharmacovigilance Practices (GVP)
What is an Adverse Drug Reaction (ADR)?
Course Code: ELM-920
QRM
What is ICH Q9?
Course Code: ELM-232a
QRM
Defining Quality Risk Management
Course Code: ELM-232a
EU MDR
Confidentiality Protections
Course Code: ELM-325
EU MDR
Member State Penalties
Course Code: ELM-325
EU MDR
EU MDR Competent Authorities
Course Code: ELM-324
Change Control
Defining Change Management
Course Code: ELM-160
Change Control
The FDA and Change Control
Course Code: ELM-159
Change Control
Required: Document Control System
Course Code: ELM-180
Change Control
The Importance of Revalidation
Course Code: ELM-180
1SO 14971:2019
The Basics of a Risk Analysis Process
Course Code: ELM-336
Contamination Control & Aseptic Techniques
The FDA’s Contamination Standards
Course Code: ELM-701
Contamination Control & Aseptic Techniques
4 Categories of Contaminants
Course Code: ELM-701
1SO 14971:2019
Wireless Risk Analysis
Course Code: ELM-338
1SO 14971:2019
Cybersecurity
Course Code: ELM-338
Data Integrity (ALCOA)
9 Common Types of Data Integrity Issues
Course Code: ELM-151
Data Integrity (ALCOA)
CSV Best Practices
Course Code: ELM-154
1SO 14971:2019
Risk Controls: AFAP vs. ALARP Approach
Course Code: ELM-337
1SO 14971:2019
How To Evaluate Risk
Course Code: ELM-337
CSV - Intermediate
GAMP®5 Recommendations and Best Practices [Video]
Course Code: ELM-132
Equipment Qualification
Qualification, Explained
Course Code: ELM-183
Equipment Qualification
Commissioning 101: What You Need to Know
Course Code: ELM-183
Good Manufacturing Practices (cGMP) - Beginner
The FDA’s Role in Pharmaceutical Regulation
Course Code: ELM-722
Good Manufacturing Practices (cGMP) - Beginner
What is GMP?
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
Medical Device Validation
US Medical Device Regulations You Must Know
Course Code: ELM-156
Medical Device Validation
An Overview of the Medical Device Product Life Cycle
Course Code: ELM-156
CSV - Intermediate
CSV Periodic Review vs. Continual Monitoring [Video]
Course Code: ELM-149B
Equipment Qualification
The 3 Parameters to Consider During Any Risk Analysis Process
Course Code: ELM-182
Equipment Qualification
The Team You Need to Create the Perfect URS [Video]
Course Code: ELM-182
Good Laboratory Practices (cGLP)
Which FDA Regulations Apply to Laboratory Practices?
Course Code: ELM-101
Equipment Qualification
Want to Know the 3 Major Impacts for CQV Activities?
Course Code: ELM-181
Process Validation
The Difference Between Qualification and Validation
Course Code: ELM-181
CSV - Intermediate
Your 1 Minute Guide to FDA Warning Letters [Video]
Course Code: ELM-149B
CSV - Intermediate
Your 1 Minute Guide to Re-Validation for CSV [Video]
Course Code: ELM-166A
CSV - Intermediate
Your 1 Minute Guide to Change Control for CSV [Video]
Course Code: ELM-166A
CSV - Intermediate
Your 1 Minute Guide to Impact Assessment for CSV
Course Code: ELM-166A
CSV - Intermediate
The Importance of Attributable for CSV Testing
Course Code: ELM-165B
CSV - Intermediate
CSV – Logical Testing Chunks Work Best [Video]
Course Code: ELM-165A
CSV - Intermediate
Your 1 Minute Guide to Software IQ’s [Video]
Course Code: ELM-165A
CSV - Intermediate
Statistically Based Approaches for CSV [Video]
Course Code: ELM-164
CSV - Intermediate
Testing Requirements Vs Testing the Implementation (CSV)
Course Code: ELM-165A
CSV - Intermediate
Your 1 Minute Guide to Testing Software Alarms [Video]
Course Code: ELM-165A
CSV - Intermediate
All You Need to Know About Exploratory Testing [Video]
Course Code: ELM-165A
Medical Device Validation
Don’t Forget to Include Test Equipment in Your Validation Plan!
Course Code: ELM-164
1SO 14971:2019
Criteria for Risk Acceptability [ISO 14971]
Course Code: ELM-335
1SO 14971:2019
Your 2 Minute Guide to Risk Severity [ISO 14971]
Course Code: ELM-335
Good Laboratory Practices (cGLP)
The US Regulatory Requirements for Laboratory Investigations [Video]
Course Code: ELM-174
CSV - Intermediate
Plan for the Unexpected – Protocol Issues [Video]
Course Code: ELM-163
CSV - Intermediate
How to Deal with CSV Test Failures [Video]
Course Code: ELM-163
CSV - Intermediate
How to Create a Risk Matrix for CSV Projects [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
1SO 14971:2019
Med Device Risk Management vs. Residual Risk
Course Code: ELM-333
Process Validation
Your 1 Minute Guide to Master Validation Plans [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
Do You Understand What a FAT Means? [Video]
Course Code: ELM-121
Process Validation
How CSV Applies to an Enzyme Analysis System [Video]
Course Code: ELM-157
Process Validation
How to Deal with Test Failures & Issues [Video]
Course Code: ELM-157
Medical Device Validation
The 4 Flavors of Medical Device Validation [Video]
Course Code: ELM-157
Good Manufacturing Practices (cGMP) - Beginner
Are Your Personnel Adhering to CFR 211.28 to Avoid Contamination? [Video]
Course Code: ELM-211
Data Integrity (ALCOA)
How Legible Applies to CSV – ALCOA+ [Video]
Course Code: ELM-154
Data Integrity (ALCOA)
Never Back Date If You Want Data with Integrity [Video]
Course Code: ELM-153
Good Manufacturing Practices (cGMP) - Beginner
Don’t Forget cGMP Training is a Regulatory Requirement! [Video]
Course Code: ELM-211
Good Manufacturing Practices (cGMP) - Beginner
Your 60 Second Guide to Gang Printed Labelling [211.122]
Course Code: ELM-209
Data Integrity (ALCOA)
How Data Integrity Applies to Time Formats [Video]
Course Code: ELM-153
Data Integrity (ALCOA)
How Attributable Applies to CSV – ALCOA+ [Video]
Course Code: ELM-154
Data Integrity (ALCOA)
The 6 Basic Rules of Controlled Documents [GDP]
Course Code: ELM-153
Data Integrity (ALCOA)
ALCOA+ The Meaning of Available [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Enduring [Video]
Course Code: ELM-152
Good Manufacturing Practices (cGMP) - Beginner
What the FDA Expects for Equipment Design, Size, and Location (Sect. 211.63) [Video]
Course Code: ELM-212
Data Integrity (ALCOA)
ALCOA+ The Meaning of Consistent [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Complete [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Accurate [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Original [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Contemporaneous [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Legible [Video]
Course Code: ELM-152
Data Integrity (ALCOA)
ALCOA+ The Meaning of Attributable [Video]
Course Code: ELM-152
Contamination Control & Aseptic Techniques
How to Visually Inspect a RABS Glove [Video]
Course Code: ELM-708
Data Integrity (ALCOA)
The Difference Between ALCOA & ALCOA+  
Course Code: ELM-152
Data Integrity (ALCOA)
The FDA’s Response to Data Integrity Issues
Course Code: ELM-151
Data Integrity (ALCOA)
Unintentional Vs Intentional Data Integrity Mistakes [Video]
Course Code: ELM-148
Data Integrity (ALCOA)
Why is Data Integrity So Important? [Video]
Course Code: ELM-148
Data Integrity (ALCOA)
The 4 Most Common Data Integrity Issues [Video]
Course Code: ELM-148
EU MDR
Key Differences Between MDD & EU MDR
Course Code: ELM-316
Contamination Control & Aseptic Techniques
Returning to Work in a GMP Environment After Coronavirus
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]
21 CFR Part 820
Your 1 Minute Guide to the NCR Process [Video]
Course Code: ELM-309
Combination Products
Stability Requirements for Combination Products [Video]
Course Code: ELM-146
Combination Products
3 Types of Combination Products You Should Know [Video]
Course Code: ELM-145
Contamination Control & Aseptic Techniques
Contamination in a GMP Environment Leads to FDA Warning Letters!
Course Code: ELM-105
Combination Products
How the FDA Defines a Combination Product [Video]
Course Code: ELM-145
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
ISO 13485:2016
Medical Device Reporting Timelines for the US
Course Code: ELM-807
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Scope Analysis
Course Code: ELM-117
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
Key CAPA Concepts & Examples
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Systemic Issues
Course Code: ELM-117
Good Manufacturing Practices (cGMP) - Beginner
CAPA Basics: Corrective Action
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)
Ground Rules for Lab Notebook Data Entry
Course Code: ELM-104
Good Documentation Practices (GDocP)
Company Supporting Procedures Pertaining to Logbooks
Course Code: ELM-104
Good Documentation Practices (GDocP)
Good Documentation Practices, Simplified
Course Code: ELM-501
Good Documentation Practices (GDocP)
GDocP: Making Multiple Corrections on a Document
Course Code: ELM-502
Good Documentation Practices (GDocP)
GDocP: Best Practices for Languages
Course Code: ELM-104
Good Documentation Practices (GDocP)
The Importance of a Signature Specimen File
Course Code: ELM-104
Good Documentation Practices (GDocP)
Deciding on Document Approvers
Course Code: ELM-104
Good Documentation Practices (GDocP)
Document Control: Signatures
Course Code: ELM-104
Good Documentation Practices (GDocP)
Documents Within the Scope of GDocP
Course Code: ELM-104
Good Documentation Practices (GDocP)
Benefits of Good Documentation Practices
Course Code: ELM-501
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
Design Control Basics – ISO 13485:2016
Course Code: ELM-805
ISO 13485:2016
Requirements for Management Review | ISO 13485
Course Code: ELM-803
ISO 13485:2016
Top Management Commitment to Quality | 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)
2-Minute Guide to Clinical Trial Investigators
Course Code: ELM-901
Good Clinical Practices (cGCP)
Key Principles of Good Clinical Practice (GCP)
Course Code: ELM-901
Good Clinical Practices (cGCP)
GCP | The Belmont Report Explained
Course Code: ELM-901
Good Clinical Practices (cGCP)
Major Responsibilities of the Institutional Review Board (IRB)
Course Code: ELM-901
FDA Inspection Readiness (GMP Auditing)
Key Process Principles of GMP Audits
Course Code: ELM-122
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
FDA Inspection Readiness (GMP Auditing)
3 Critical Reasons for GMP Auditing
Course Code: ELM-122
FDA Inspection Readiness (GMP Auditing)
The GMP Audit Defined
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)
What is Laboratory Data Integrity? [Video]
Course Code: ELM-102
Data Integrity (ALCOA)
How to Ensure the Integrity of Laboratory Data [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
Why GMP is so Important [Video]
Course Code: ELM-219
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
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
21 CFR Part 820
Data Integrity & Controlled Areas [Video]
Course Code: ELM-802
21 CFR Part 820
The Medical Device File Index [Video]
Course Code: ELM-802
Good Manufacturing Practices (cGMP) - Beginner
Why GMP Production Should Be Performed by Qualified People [Video]
Course Code: ELM-103
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
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
Data Integrity – Records Vs Data [Video]
Course Code: ELM-114
21 CFR Part 11
The 4 Pillars of a Robust CSV Process [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
Good Manufacturing Practices (cGMP) - Beginner
Why Process Validation is Reliant on a Detailed Design Review of the Product [Video]
Course Code: ELM-401
Contamination Control & Aseptic Techniques
The 6 Key Sources of Microbial Contamination in a GMP Environment [Video]
Course Code: ELM-705
Data Integrity (ALCOA)
The Difference Between ALCOA and ALCOA+[Video]
Course Code: ELM-102
FDA Inspection Readiness (GMP Auditing)
11 Key Items to Consider When Conducting a Vendor Audit [Video]
Course Code: ELM-127
CSV - Beginner
Your 1 Minute Guide to ALCOA [Video]
Course Code: ELM-102
Process Validation
Critical Process Parameters – Process Validation
Course Code: ELM-402
FDA Inspection Readiness (GMP Auditing)
The Difference Between Horizontal & Vertical Auditing [Video]
Course Code: ELM-122
Good Documentation Practices (GDocP)
Your 1 Minute Guide to Closing Deviations Successfully [Video]
Course Code: ELM-131
Good Laboratory Practices (cGLP)
6 Key Requirements of a Cleaning Process SOP [Video]
Course Code: ELM-601
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
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
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]
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
Maximum Allowable Carryover (MAC or MACO) in a Nutshell [Video]
Course Code: ELM-601
Process Validation
Equipment Design Qualification in a Nutshell [Video]
Course Code: ELM-127
Good Documentation Practices (GDocP)
Essential Documentation for a Factory Acceptance Test (FAT) [Video]
Course Code: ELM-121
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
21 CFR Part 820
3 Key Elements Your Quality Policy Needs [Video]
Course Code: ELM-302
Good Documentation Practices (GDocP)
How to Report Laboratory Test Results Correctly [Video]
Course Code: ELM-109
FDA Inspection Readiness (GMP Auditing)
6 Key Areas for the FDA Audit for Process Validation [Video]
Course Code: ELM-401
Data Integrity (ALCOA)
The 5 Principles of Data Integrity – ALCOA [Video]
Course Code: ELM-102
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
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
Good Laboratory Practices (cGLP)
The 9 Golden Rules – Ensuring Laboratory Data Integrity [Video]
Course Code: ELM-102
FDA Inspection Readiness (GMP Auditing)
The Four Phases of Conducting a Laboratory Investigation [Video]
Course Code: ELM-108
21 CFR Part 820
Audit Terminology You Need To Understand [Video]
Course Code: ELM-302
CSV - Beginner
Your Guide to Software Validation PQ’s [Video]
Course Code: ELM-111
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
FDA Inspection Readiness (GMP Auditing)
Rounding of Numbers and the Tie Break Rule – Essential for Laboratory Analysis
Course Code: ELM-109
Contamination Control & Aseptic Techniques
Considerations of Sterile Filtration Validation: 21 CFR 211.113 (b)
Course Code: ELM-121
FDA Inspection Readiness (GMP Auditing)
Direct Impact System
Course Code: ELM-121
FDA Inspection Readiness (GMP Auditing)
Obstructing Regulatory Inspections – Part 2
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
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
The Project Management Mindset!
Good Manufacturing Practices (cGMP) - Beginner
Cleaning Validation: The Critical Steps Involved
Good Manufacturing Practices (cGMP) - Beginner
How Well-Designed Weighing Processes Improve Quality
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 Manufacturing Practices (cGMP) - Beginner
Project Charter: A Worked Example
Good Manufacturing Practices (cGMP) - Beginner
Project Charter – Pleasure or Pain?
Contamination Control & Aseptic Techniques
Why Are My Swab Recoveries So Low?
Good Laboratory Practices (cGLP)
How to Conduct an Analytical Method Transfer
Good Manufacturing Practices (cGMP) - Beginner
Top 9 Tips for Successful Implementation of FMEA
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 Manufacturing Practices (cGMP) - Beginner
Are You Moaning About Cleaning Validation?
Contamination Control & Aseptic Techniques
Preparation and Planning for a GMP Audit
Good Manufacturing Practices (cGMP) - Beginner
Quality Risk Management within the Pharmaceutical Industry
Good Manufacturing Practices (cGMP) - Beginner
Top 10 Concerns Associated with Clinical Trials
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 Documentation Practices (GDocP)
Document Retention: Regulatory Guidance
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
Levels Of Flexibilities In Flexible Manufacturing Systems
Good Manufacturing Practices (cGMP) - Beginner
Manufacturing Engineering Systems And The Challenges
Good Manufacturing Practices (cGMP) - Beginner
Saturated Steam – Efficient Sterilization
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
Out Of Trend Results – OOT’s
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
Airlocks – The Ventricles of Cleanroom
Good Manufacturing Practices (cGMP) - Beginner
Blend Uniformity in Pharmaceutical Solid Dosage Forms
Good Manufacturing Practices (cGMP) - Beginner
Production Line Balancing
Good Documentation Practices (GDocP)
The Power Of Word Processing And Typing Skills.
Contamination Control & Aseptic Techniques
How We Contaminate Clean Rooms?
Good Manufacturing Practices (cGMP) - Beginner
Cleaning In Place (CIP) Vs Cleaning Out of Place (COP)
Good Manufacturing Practices (cGMP) - Beginner
Cleaning Validation Methods
Good Manufacturing Practices (cGMP) - Beginner
Process Robustness in Pharmaceutical Manufacturing
Good Manufacturing Practices (cGMP) - Beginner
Critical Parameters Affecting Process Validation
Good Manufacturing Practices (cGMP) - Beginner
Warehousing Mapping a Brief Guide to Success
Good Manufacturing Practices (cGMP) - Beginner
4 Steps to Risk Analysis & Management
21 CFR Part 820
The Difference Between a FAT and a SAT [Video]
Course Code: ELM-307
Good Manufacturing Practices (cGMP) - Beginner
Manufacturing Execution Systems (MES) & Validation
Good Manufacturing Practices (cGMP) - Beginner
The Qualified Person (QP) and Validation
Good Manufacturing Practices (cGMP) - Beginner
Water Generation and Distribution System Qualification Program
Contamination Control & Aseptic Techniques
Personnel Qualification in Aseptic Areas
FDA Inspection Readiness (GMP Auditing)
Vendor Audits – Top Tips

Featured Courses

Course Code
Course Name
Duration
Good Manufacturing Practices (cGMP) - Beginner
Good Laboratory Practices (cGLP)
Good Documentation Practices (GDocP)
Data Integrity (ALCOA)
CSV - Beginner
Contamination Control & Aseptic Techniques
21 CFR Part 820
Process Validation
21 CFR Part 11
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