ComplianceOnline

Mobile Learning

Are you using mobile devices to bolster your compliance training programs? If NOT, It's time.

A recent study by the eLearning Guild revealed that:

  • More than 70% of Americans already use their personal phones for work purposes.
  • 92% of firms surveyed said they know their employees are using their own devices in the workplace.

The figures clearly shows that companies are catching on the usage of the mobile devices.

Introduction to 21 CFR Part 11

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    1. A comprehensive history and detailed overview of 21 CFR Part 11
    2. Specifics on Subpart A: General Provisions
    3. Specifics on Subpart B: Electronic Records
    4. Specifics on Subpart C: Electronic Signatures
    5. Complete scope of regulations and their direct applications
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
The 21 CFR Part 11 course package includes four interactive modules, short quizzes and Q&A that will familiarize your employees with the real-world requirements of this important FDA regulation. It will help you understand 21 CFR Part 11 requirements for closed systems, open systems, electronic signatures and signing electronic records.
$99

How to Prepare for, Manage, and Follow-up to an FDA Inspection

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    FDA Inspection Program Overview

    1. FDA Authority to Inspect
    2. FDA Inspectional Priority

    FDA Inspection Preparation

    1. Types of Inspections
    2. Pre-inspection Preparation
    3. Inspection Notice
    4. FDA Inspection Techniques

    Managing FDA Inspections

    1. Inspection Process
    2. Close-out Meeting
    3. Inspection Outcomes
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FDA inspection training program will cover best practices for managing FDA inspection and will also explain how to respond to FDA 483s and warning letters.
$99

Meet the Tougher U.S. FDA CGMPs

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    US FDA Regulatory Law

    1. FDA Changing Targets
    2. Rising Expectations
    3. Avoid Complacency from Past Audits

    cGMP Requirements

    1. Device and Drug cGMP Elements
    2. Quality System Regulations
    3. Documentation Requirements
    4. High Risk Issues

    FDA cGMP Audits

    1. FDA Quality System Inspection Technique
    2. Proactive Actions
    3. Audit Sequence and Responses
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FDA GMP training covers FDA's approach to cGMP Audits, expectation from companies, chief concern areas of cGMP compliance.
$99

Creating FDA-compliant cGMP Training Program

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Regulatory Requirements and Expectations for Well-trained Workforce

    1. FDA Observations
    2. Regulatory Requirements for Biologics and Medical Devices
    3. Regulatory Requirements for Pharmaceuticals and Consultants

    Implementing An Effective FDA Compliant GMP Training Program

    1. Management Responsibilities
    2. Stages of Implementation: Planning
    3. Designing and Delivering Content

    Follow-up Efforts that Reinforce GMP Training

    1. What to do After Class is Over
    2. Measuring Training Effectiveness
    3. Creating GMP Compliance Culture
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This course will explain how to implement an effective and FDA compliant GMP training program. It will also discuss regulatory requirements and expectations for a well-trained workforce.
$99

Supplier Management for GMP: Quality Agreements and More

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Vendor Qualification and Management

    1. Common Audit Findings
    2. Aspects of Vendor Qualification

    Vendor Selection and Validation Requirements

    1. When Not to Use a Vendor
    2. Access Control Parameters
    3. Critical Quality Attributes for Testing
    4. Risk Management Process
    5. Vendor Change Control

    Documentation Requirements and Quality Agreements

    1. Record Keeping Requirements
    2. Vendor Issues
    3. FDA Guidance for Quality Agreements
    4. Quality Agreements and its Elements
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This training will explain FDA's regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will also discuss the current regulations, guidance documents and best practices for supplier management.
$99

Project Management for Auditors - Improving Audit Productivity for GCP, GMP and GLP

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Project Management Overview

    1. Impact of Project Management
    2. Typical Characteristics of Projects

    Project Management Principles

    1. Key Project Management Definitions
    2. Setting Project Objectives
    3. Defining Project Scope
    4. Project Planning Process

    Project Management Principles

    1. Site Audit
    2. Defining Activity Dependencies
    3. Risk Management
    4. Resource Management
    5. Monitoring and Controlling Audit Projects
    6. Closing the Audit Project
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This training will provide you with an excellent understanding of project management skills, to apply to auditing in all GXP areas including GMP,GCP and GLP
$99

FDA Good Manufacturing Practices (GMP) Basics for Finished Pharmaceuticals and APIs

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    GMP Basics

    1. History
    2. Importance of Complying with GMP
    3. The FDA GMP Regulations
    4. 21 CFR Part 211

    GMP Requirements for:

    1. Organization and Personnel
    2. Buildings and Facilities
    3. Equipment
    4. Control of Components and Drug Product Containers and Closures
    1. Production and Process Controls
    2. Laboratory Controls
    3. Packaging and Labeling Control
    4. Holding and Distribution
    5. Records and Reports
    6. Returned and Salvaged Drug Products
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This comprehensive GMP compliance training comprises of four interactive modules and Q&A that has been designed to help pharma industry professionals understand the basics of the FDA's Good Manufacturing Practices regulation for finished pharmaceuticals and APIs.
$99

US, EU, Japan GMP Requirements: Practical ICH Area Differences

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Regulatory Overview

    1. US FDA Regulatory Structure
    2. EU Regulatory Structure
    3. Japanese Regulatory Bodies

    GMP Overview

    1. Good Manufacturing Practices
    2. Regional Differences
    3. GMP Regulations in the U.S., EU and Japan
    4. Importance of GMP Compliance

    U.S., EU and Japan GMPs - Status of Harmonization

    1. Harmonization Update
    2. Roadblocks to Harmonization
    3. Overlap of ICH GMP Guidelines

    GMP Category Review for Finished Products and APIs

    1. GMP Production Categories
    2. Quality Management & Systems
    3. Quality Assurance Program
    4. Returns & Salvage Regulations
    5. Finished Product/API Differences

    GMP for Biologics & Sterile Products

    1. Biologics and Sterile Products
    2. GMP Comparison - Biological/Sterile
    3. Guidance on Excipient GMP
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This compliance training will provide a comprehensive understanding of ICH GMPs for U.S, EU and Japan and key ICH area differences.
$99

US, EU, Japan GMP Requirements: Healthcare Authority Inspection Focus

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    GMP Overview

    1. Good Manufacturing Practices
    2. Regional Differences
    3. GMP Regulations in the US, EU and Japan
    4. Importance of GMP Compliance

    GMP Internal Inspection Review

    1. What to look for?
    2. Self Inspection Timing
    3. Self Inspection Team
    4. Conducting the Self Inspection

    GMP External Inspection Review & Approaches

    1. Types of Inspections
    2. Risk-Based Inspection Approach
    3. FDA Quality System Model
    4. Typical HCA GMP Inspection Agenda
    5. Inspection Process

    GMP Inspection & Observation Differences by Region

    1. General Differences by Region
    2. FDA Inspection Specifics
    3. EU Inspection Specifics
    4. Japanese Inspection Specifics
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This GMP compliance training covers expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA
$99

FDA GMP Audit Practices and 10 Most Common Cited GMP Deficiencies

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Audit Techniques of a FDA Auditors

    1. FDA Current Audit Techniques
    2. Types of Operator Errors
    3. Risk Based Approach

    Quality Control System Components

    1. Quality System & Phases
    2. Facility and Equipment Systems
    3. Production and Materials System
    4. Laboratory Control Measures
    5. Packaging and Labeling Systems

    How to Address FDA 483 Observations

    1. Best Practices to Address 483
    2. 10 Most Common GMP Drug Deficiencies
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This GMP training will help you understand FDA's current audit practices in the pharma, biotechnology and medical devices industries to avoid 483s and warning letters.
$99

Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    FDA GMP Requirements for Raw Material Management

    1. GMP and Raw Material
    2. Raw Material Regulations
    3. Ensuring Good Quality Raw Materials
    4. Good Documentation Practices
    5. Common Issues with Compliance

    Vendor Selection and Validation Requirements

    1. Aspects of Vendor Qualification
    2. Access Control Parameters
    3. Critical Quality Attributes for Testing
    4. Vendor Change Control

    Quality Agreements

    1. FDA Guidance for Quality Agreements
    2. Local, Regional and International Vendors
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FDA training will help you understand the current requirements for raw material management including raw material vendor selection, expectations from quality control and documentation processes, and training requirements, with case studies.
$99

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

  • Duration: 45 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    1. Introduction to Pharmaceutical Compressed Air
    2. Compressed Air - Importance of Quality
    3. Pharmaceutical Compressed Air System Design
    4. Regulatory Requirements

    Contamination Types and their Regulations

    1. Solid Particulate Contamination
    2. Water Content Contamination
    3. Total Oil Content Contamination

    Bioburden Contamination

    1. Bioburden Measurement
    2. Bioburden-Regulations and Specifications
    3. Bioburden Removal
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This training will discuss the primary sources of compressed air contamination and will also detail GMP standards and requirements pertaining to compressed air quality.
$99

HVAC and GMP Environmental Control

  • Duration: 70 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Regulatory Requirements for Cleanroom Classifications

    1. Cleanroom Regulations
    2. Air Handling Unit
    3. Cleanroom Design Considerations

    HVAC Control System

    1. Air Flow Patterns and Rates
    2. Temperature and Humidity Controls
    3. Electrostatic Controls
    4. HEPA Filtration

    HVAC Monitoring and Validation System

    1. Non-Viable Particulate Monitoring Systems
    2. Microbial Monitoring Systems
    3. Personnel Practices in Cleanroom
    4. HVAC System Validation
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This HVAC and GMP environmental control training will explain the various US and international regulatory requirements for cleanroom classifications. It will also provide a comprehensive overview of the mechanics of cleanroom HVAC including engineering diagrams and schematics.
$99

Human Error Reduction in GMP Related Environments

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Understanding Human Error: Factors and Causes

    1. Background on Human Error Phenomena
    2. Types of Error
    3. Human Error Cause Categories

    Human Error Prevention Program

    1. Tools for Preventing Human Error
    2. Root Cause Determination Tool
    3. Cognitive Load Tool
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This GMP training program will provide an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
$99

GMP Requirements for Validation and Re-Validation of Analytical Procedures

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Method Validation and Common Deficiencies

    1. Types of Medications
    2. Deficiencies Related to Method Validation
    3. Drug Development Process
    4. Factors Affecting Quality of Medicines

    Validation Requirements for Analytical Procedures

    1. cGMP and ICH Guidelines
    2. Validation Characteristics
    3. Stress Testing

    Re-validation of Analytical Procedures

    1. Life Cycle of Analytical Methods
    2. Re-validation: When is it Necessary
    3. General Requirements for Verification
    4. Relationship of Verification, Validation and Re-validation
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This GMP training program will explain the cGMP and ICH validation requirements for analytical procedures and will review the differences between validation and re-validation plan.
$99

Auditing QC and Contract Laboratories for GMP Compliance

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Conducting Laboratory Audits

    1. Importance of Laboratory Audits
    2. Procedure for Laboratory Audits
    3. Audit Rating, Report and Follow-up

    Comprehensive GMP Audit Items

    1. Auditing Laboratory Quality Systems
    2. Documentation and Procedures
    3. Auditing Equipment, Methods and Material

    Sample Handling and FDA Inspection Findings

    1. Sampling and Data Workflow
    2. Record Archiving and Stability Testing
    3. Inspection Deviations
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This laboratory compliance training will help you to prepare for FDA inspections, while detailing documentation requirements to ensure compliance.
$99

FDA Inspection Preparedness: BIMO Compliance Program

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    BIMO Inspection Program

    1. Key Terms and Responsibilities
    2. General Purpose of FDA Inspection
    3. BIMO Program
    4. Inspection Focal Points

    FDA Inspection Process

    1. Notification of Inspection
    2. Inspection Preparation Strategies
    3. Do's and Don'ts during Inspection

    How to Respond to the FDA

    1. Possible Inspection Outcomes
    2. Common Deficiencies
    3. Best Practices to Respond to FDA
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FDA compliance training will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also enhance your inspection preparation strategies.
$99

HIPAA Privacy and Security Compliance Training

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Definition and application of HIPAA

    The importance of HIPAA within an organization

    Specific rules and regulations of HIPAA;

    1. HIPAA Enforcement
    2. Patient Rights
    3. HIPAA Privacy Requirements
    4. The Breach Notification Rule
    5. Release of Information (ROI)
    6. HIPAA Security Rule
    7. PHI Safeguarding Tips
    8. Business Associate Agreements

    An overview of HIPAA violations and complaints

  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This compliance training will familiarize employees of healthcare providers, health plans and other HIPAA covered entities with the requirements of the HIPAA Privacy and Security Rules.
$99

The Basics of Anti-Money Laundering - AML Laws and Red Flags

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    The course will help you understand

    1. What is money-laundering
    2. The requirements of US anti-money laundering regulations
    3. Why money laundering is a huge risk for banks and other financial institutions
    4. Red flags of money laundering
    5. How to identify suspicious behavior associated with money laundering
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This AML compliance training is aimed at helping customer-facing staff and other professionals working in US financial institutions better understand the anti-money laundering regulations. This will help you to identify the red flags of money laundering
$99

The Basics of Anti-Money Laundering - Reporting Requirements and Best Practices (Part2)

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Requirements of US Anti-money Laundering Regulations

    1. Bank Secrecy Act (BSA)
    2. US PATRIOT Act

    The Important Regulatory Reporting Requirements under AML Laws

    1. Currency Transaction Report (CTR)
    2. International Transportation of Currency or Monetary Instruments Reporting (CMIR)
    3. Report of Foreign Bank and Financial Accounts (FBAR)
    4. Suspicious Activity Report (SAR)

    Best Practices to Prevent Money Laundering

    Customer Identification Program (CIP)

    Customer Due Diligence (CDD) Program

    BSA/AML Risk Assessment

    Identification and Reporting of Suspicious Activity

  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This AML training will give you a comprehensive overview of anti-money laundering regulations, reporting requirements and best practices to prevent money laundering.
$99

Basics of U.S. Export Controls

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    U.S. Export Controls- Brief Overview

    1. Key Definitions
    2. When Do We Need Export Controls
    3. U.S. Government Export Controls and Agencies
    4. U.S. Export/Sanctions Rules

    Export Administration Regulations

    1. How EAR affects non-US Transactions
    2. Commerce Control List (CCL)
    3. License Requirements
    4. Reasons for Control
    5. Penalties for Non-compliance With EAR

    International Traffic in Arms Regulations

    1. Exports Under the ITAR
    2. Types of License
    3. Penalties for Non-compliance with ITAR
    4. Checklist for ITAR Controlled Technical Data

    Economic Sanctions

    1. Restrictions Under U.S. Economic Sanctions
    2. Export to Sanctioned Countries - Best Practices
    3. U.S. Export Considerations to Sanctioned Countries : Checklist
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This trade compliance training aims to help professionals dealing with exports of products, software or technology from the U.S. better understand export control laws and regulations including EAR, ITAR and economic sanction regulations.
$99

The Basics of the Fair Labor Standards Act

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    U.S. Export Controls- Brief Overview

    1. Key Definitions
    2. When Do We Need Export Controls
    3. U.S. Government Export Controls and Agencies
    4. U.S. Export/Sanctions Rules

    Export Administration Regulations

    1. How EAR affects non-US Transactions
    2. Commerce Control List (CCL)
    3. License Requirements
    4. Reasons for Control
    5. Penalties for Non-compliance With EAR

    International Traffic in Arms Regulations

    1. Exports Under the ITAR
    2. Types of License
    3. Penalties for Non-compliance with ITAR
    4. Checklist for ITAR Controlled Technical Data

    Economic Sanctions

    1. Restrictions Under U.S. Economic Sanctions
    2. Export to Sanctioned Countries - Best Practices
    3. U.S. Export Considerations to Sanctioned Countries : Checklist
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FLSA compliance training aims to help professionals working in human resources, payroll, finance and accounts department better understand the requirements of the Fair Labor Standards Act and enforcement of FLSA
$99

Complying with the Foreign Corrupt Practices Act

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Foreign Corrupt Practices Act (FCPA) Basics

    1. History and Background
    2. Importance of FCPA Compliance
    3. Costs of Non-Compliance

    FCPA Provisions:

    1. Basic Principles of the FCPA
    2. Description of FCPA - Bribery Section
    3. FCPA Accounting Provisions
    4. Exceptions to the FCPA

    Red Flags for FCPA Violations:

    1. Red Flags for FCPA Anti-bribery Section
    2. Red Flags for Agents
    3. Red Flags for FCPA Accounting Violations

    Entertainment and Travel Expenses

  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
This FCPA compliance training will help professionals working in global organizations understand the regulatory requirements of the Foreign Corrupt Practices Act as well as the dos and don'ts they should follow to ensure compliance
$99

Complying with the SEC's Conflict Minerals Rule

  • Duration: 60 minutes
  • Available On:
  • Areas Covered

    Areas Covered:

    Conflict Mineral Basics

    1. Definition of a Conflict Mineral and its Usage
    2. SEC's Conflict Mineral Rule and its Requirements
    3. Why Compliance is Necessary?

    How to Comply with the SEC Conflict Mineral Rule

    1. Applicability of Rule
    2. Reasonable Country of Origin Inquiry (RCOI)
    3. Due Diligence
    4. Monitoring Supply Chain
    5. Risk Assessment

    Reporting Requirements and Third Party Audits

    1. Conflict Minerals Report
    2. Filling in the Form SD
    3. Due Diligence Outcomes
    4. Third Party Audits
  • How it Works
    Buy Now button link will take you to domain
    http://complianceonline.morflearning.com for registration.
    MorfLearning.com is our partner for Mobile App.
Learn various compliance related issues that arise with the use of conflict minerals and how to deal with these to ensure compliance with the SEC's Conflict Mineral Rule
$99

FDA GMP Training Package (12 Courses)

$600
$1,200