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- Packaged Trainings
Introduction to 21 CFR Part 11
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
- A comprehensive history and detailed overview of 21 CFR Part 11
- Specifics on Subpart A: General Provisions
- Specifics on Subpart B: Electronic Records
- Specifics on Subpart C: Electronic Signatures
- Complete scope of regulations and their direct applications
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- FDA Authority to Inspect
- FDA Inspectional Priority
FDA Inspection Preparation
- Types of Inspections
- Pre-inspection Preparation
- Inspection Notice
- FDA Inspection Techniques
Managing FDA Inspections
- Inspection Process
- Close-out Meeting
- Inspection Outcomes
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Meet the Tougher U.S. FDA CGMPs
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
US FDA Regulatory Law
- FDA Changing Targets
- Rising Expectations
- Avoid Complacency from Past Audits
cGMP Requirements
- Device and Drug cGMP Elements
- Quality System Regulations
- Documentation Requirements
- High Risk Issues
FDA cGMP Audits
- FDA Quality System Inspection Technique
- Proactive Actions
- Audit Sequence and Responses
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Creating FDA-compliant cGMP Training Program
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Regulatory Requirements and Expectations for Well-trained Workforce
- FDA Observations
- Regulatory Requirements for Biologics and Medical Devices
- Regulatory Requirements for Pharmaceuticals and Consultants
Implementing An Effective FDA Compliant GMP Training Program
- Management Responsibilities
- Stages of Implementation: Planning
- Designing and Delivering Content
Follow-up Efforts that Reinforce GMP Training
- What to do After Class is Over
- Measuring Training Effectiveness
- Creating GMP Compliance Culture
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Supplier Management for GMP: Quality Agreements and More
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Vendor Qualification and Management
- Common Audit Findings
- Aspects of Vendor Qualification
Vendor Selection and Validation Requirements
- When Not to Use a Vendor
- Access Control Parameters
- Critical Quality Attributes for Testing
- Risk Management Process
- Vendor Change Control
Documentation Requirements and Quality Agreements
- Record Keeping Requirements
- Vendor Issues
- FDA Guidance for Quality Agreements
- Quality Agreements and its Elements
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- Impact of Project Management
- Typical Characteristics of Projects
Project Management Principles
- Key Project Management Definitions
- Setting Project Objectives
- Defining Project Scope
- Project Planning Process
Project Management Principles
- Site Audit
- Defining Activity Dependencies
- Risk Management
- Resource Management
- Monitoring and Controlling Audit Projects
- Closing the Audit Project
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
FDA Good Manufacturing Practices (GMP) Basics for Finished Pharmaceuticals and APIs
- Duration: 45 minutes
- Available On:
- Areas Covered
Areas Covered:
GMP Basics
- History
- Importance of Complying with GMP
- The FDA GMP Regulations
- 21 CFR Part 211
GMP Requirements for:
- Organization and Personnel
- Buildings and Facilities
- Equipment
- Control of Components and Drug Product Containers and Closures
- Production and Process Controls
- Laboratory Controls
- Packaging and Labeling Control
- Holding and Distribution
- Records and Reports
- Returned and Salvaged Drug Products
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
US, EU, Japan GMP Requirements: Practical ICH Area Differences
- Duration: 45 minutes
- Available On:
- Areas Covered
Areas Covered:
Regulatory Overview
- US FDA Regulatory Structure
- EU Regulatory Structure
- Japanese Regulatory Bodies
GMP Overview
- Good Manufacturing Practices
- Regional Differences
- GMP Regulations in the U.S., EU and Japan
- Importance of GMP Compliance
U.S., EU and Japan GMPs - Status of Harmonization
- Harmonization Update
- Roadblocks to Harmonization
- Overlap of ICH GMP Guidelines
GMP Category Review for Finished Products and APIs
- GMP Production Categories
- Quality Management & Systems
- Quality Assurance Program
- Returns & Salvage Regulations
- Finished Product/API Differences
GMP for Biologics & Sterile Products
- Biologics and Sterile Products
- GMP Comparison - Biological/Sterile
- Guidance on Excipient GMP
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
US, EU, Japan GMP Requirements: Healthcare Authority Inspection Focus
- Duration: 45 minutes
- Available On:
- Areas Covered
Areas Covered:
GMP Overview
- Good Manufacturing Practices
- Regional Differences
- GMP Regulations in the US, EU and Japan
- Importance of GMP Compliance
GMP Internal Inspection Review
- What to look for?
- Self Inspection Timing
- Self Inspection Team
- Conducting the Self Inspection
GMP External Inspection Review & Approaches
- Types of Inspections
- Risk-Based Inspection Approach
- FDA Quality System Model
- Typical HCA GMP Inspection Agenda
- Inspection Process
GMP Inspection & Observation Differences by Region
- General Differences by Region
- FDA Inspection Specifics
- EU Inspection Specifics
- Japanese Inspection Specifics
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- FDA Current Audit Techniques
- Types of Operator Errors
- Risk Based Approach
Quality Control System Components
- Quality System & Phases
- Facility and Equipment Systems
- Production and Materials System
- Laboratory Control Measures
- Packaging and Labeling Systems
How to Address FDA 483 Observations
- Best Practices to Address 483
- 10 Most Common GMP Drug Deficiencies
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- GMP and Raw Material
- Raw Material Regulations
- Ensuring Good Quality Raw Materials
- Good Documentation Practices
- Common Issues with Compliance
Vendor Selection and Validation Requirements
- Aspects of Vendor Qualification
- Access Control Parameters
- Critical Quality Attributes for Testing
- Vendor Change Control
Quality Agreements
- FDA Guidance for Quality Agreements
- Local, Regional and International Vendors
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
- Duration: 45 minutes
- Available On:
- Areas Covered
Areas Covered:
- Introduction to Pharmaceutical Compressed Air
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Regulatory Requirements
Contamination Types and their Regulations
- Solid Particulate Contamination
- Water Content Contamination
- Total Oil Content Contamination
Bioburden Contamination
- Bioburden Measurement
- Bioburden-Regulations and Specifications
- Bioburden Removal
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
HVAC and GMP Environmental Control
- Duration: 70 minutes
- Available On:
- Areas Covered
Areas Covered:
Regulatory Requirements for Cleanroom Classifications
- Cleanroom Regulations
- Air Handling Unit
- Cleanroom Design Considerations
HVAC Control System
- Air Flow Patterns and Rates
- Temperature and Humidity Controls
- Electrostatic Controls
- HEPA Filtration
HVAC Monitoring and Validation System
- Non-Viable Particulate Monitoring Systems
- Microbial Monitoring Systems
- Personnel Practices in Cleanroom
- HVAC System Validation
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Human Error Reduction in GMP Related Environments
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Understanding Human Error: Factors and Causes
- Background on Human Error Phenomena
- Types of Error
- Human Error Cause Categories
Human Error Prevention Program
- Tools for Preventing Human Error
- Root Cause Determination Tool
- Cognitive Load Tool
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- Types of Medications
- Deficiencies Related to Method Validation
- Drug Development Process
- Factors Affecting Quality of Medicines
Validation Requirements for Analytical Procedures
- cGMP and ICH Guidelines
- Validation Characteristics
- Stress Testing
Re-validation of Analytical Procedures
- Life Cycle of Analytical Methods
- Re-validation: When is it Necessary
- General Requirements for Verification
- Relationship of Verification, Validation and Re-validation
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Auditing QC and Contract Laboratories for GMP Compliance
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Conducting Laboratory Audits
- Importance of Laboratory Audits
- Procedure for Laboratory Audits
- Audit Rating, Report and Follow-up
Comprehensive GMP Audit Items
- Auditing Laboratory Quality Systems
- Documentation and Procedures
- Auditing Equipment, Methods and Material
Sample Handling and FDA Inspection Findings
- Sampling and Data Workflow
- Record Archiving and Stability Testing
- Inspection Deviations
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
GLPs vs GMPs
- What are GLPs and GMPs?
- Intent of Regulations
- Basic Elements of GLP
GLPs Guidelines
- GLPs-Organization and Personnel
- GLPs-Facilities and Equipment
- GLPs-Records and Reports
What are GMPs?
- cGMPs-General Provisions
- Organization and Personnel
- Buildings and Facilities
- Equipment
- Control of Components
GMPs Guidelines
- Production and Process Controls
- Packaging and Labeling Control
- Laboratory Controls
- Records and Reports
- Returned and Salvaged Drug Products
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
FDA Inspection Preparedness: BIMO Compliance Program
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
BIMO Inspection Program
- Key Terms and Responsibilities
- General Purpose of FDA Inspection
- BIMO Program
- Inspection Focal Points
FDA Inspection Process
- Notification of Inspection
- Inspection Preparation Strategies
- Do's and Don'ts during Inspection
How to Respond to the FDA
- Possible Inspection Outcomes
- Common Deficiencies
- Best Practices to Respond to FDA
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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;
- HIPAA Enforcement
- Patient Rights
- HIPAA Privacy Requirements
- The Breach Notification Rule
- Release of Information (ROI)
- HIPAA Security Rule
- PHI Safeguarding Tips
- Business Associate Agreements
An overview of HIPAA violations and complaints
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- What is money-laundering
- The requirements of US anti-money laundering regulations
- Why money laundering is a huge risk for banks and other financial institutions
- Red flags of money laundering
- How to identify suspicious behavior associated with money laundering
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$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
- Bank Secrecy Act (BSA)
- US PATRIOT Act
The Important Regulatory Reporting Requirements under AML Laws
- Currency Transaction Report (CTR)
- International Transportation of Currency or Monetary Instruments Reporting (CMIR)
- Report of Foreign Bank and Financial Accounts (FBAR)
- 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
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Basics of U.S. Export Controls
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
U.S. Export Controls- Brief Overview
- Key Definitions
- When Do We Need Export Controls
- U.S. Government Export Controls and Agencies
- U.S. Export/Sanctions Rules
Export Administration Regulations
- How EAR affects non-US Transactions
- Commerce Control List (CCL)
- License Requirements
- Reasons for Control
- Penalties for Non-compliance With EAR
International Traffic in Arms Regulations
- Exports Under the ITAR
- Types of License
- Penalties for Non-compliance with ITAR
- Checklist for ITAR Controlled Technical Data
Economic Sanctions
- Restrictions Under U.S. Economic Sanctions
- Export to Sanctioned Countries - Best Practices
- U.S. Export Considerations to Sanctioned Countries : Checklist
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
The Basics of the Fair Labor Standards Act
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
U.S. Export Controls- Brief Overview
- Key Definitions
- When Do We Need Export Controls
- U.S. Government Export Controls and Agencies
- U.S. Export/Sanctions Rules
Export Administration Regulations
- How EAR affects non-US Transactions
- Commerce Control List (CCL)
- License Requirements
- Reasons for Control
- Penalties for Non-compliance With EAR
International Traffic in Arms Regulations
- Exports Under the ITAR
- Types of License
- Penalties for Non-compliance with ITAR
- Checklist for ITAR Controlled Technical Data
Economic Sanctions
- Restrictions Under U.S. Economic Sanctions
- Export to Sanctioned Countries - Best Practices
- U.S. Export Considerations to Sanctioned Countries : Checklist
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Complying with the Foreign Corrupt Practices Act
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Foreign Corrupt Practices Act (FCPA) Basics
- History and Background
- Importance of FCPA Compliance
- Costs of Non-Compliance
FCPA Provisions:
- Basic Principles of the FCPA
- Description of FCPA - Bribery Section
- FCPA Accounting Provisions
- Exceptions to the FCPA
Red Flags for FCPA Violations:
- Red Flags for FCPA Anti-bribery Section
- Red Flags for Agents
- Red Flags for FCPA Accounting Violations
Entertainment and Travel Expenses
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
Complying with the SEC's Conflict Minerals Rule
- Duration: 60 minutes
- Available On:
- Areas Covered
Areas Covered:
Conflict Mineral Basics
- Definition of a Conflict Mineral and its Usage
- SEC's Conflict Mineral Rule and its Requirements
- Why Compliance is Necessary?
How to Comply with the SEC Conflict Mineral Rule
- Applicability of Rule
- Reasonable Country of Origin Inquiry (RCOI)
- Due Diligence
- Monitoring Supply Chain
- Risk Assessment
Reporting Requirements and Third Party Audits
- Conflict Minerals Report
- Filling in the Form SD
- Due Diligence Outcomes
- Third Party Audits
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$99
FDA GMP Training Package (12 Courses)
- Duration: 12 Hours
- Available On:
- How it Works
- Register to the mobile training course
- You will receive an automated email with your user ID, password and instructions to download the mobile app
- Download the app that allows you to train your staff on their smart phones and tablets
- Take the training anytime, anywhere
Buy Now button link will take you to domain
http://complianceonline.morflearning.com for registration.
MorfLearning.com is our partner for Mobile App.
$600
$1,200
$1,200