Courses as low as $75 for individual learners and $30 per group learner,
(up to 50 learners, minimum 5 courses.) See complete pricing guide.

EduDirect is UL EduNeering’s online e-learning program. These online courses are developed through our relationships with FDA and nationally recognized subject matter experts that have domain expertise in critical regulatory agencies, such as OSHA, EPA, DOT, HHS and CMS. Many of our GMP courses are reviewed by the U.S. Food and Drug Administration -- and used by FDA for new investigator training and FDA certification.

Our industry-focused authoritative curricula of courses target the diverse needs of learners, regardless of language, culture or education. These online training courses will assist organizations in achieving their regulatory and compliance goals, including FDA Part 11 Compliance, quality management systems, ISO 13485 training, and help reduce the risks associated with non-compliance. Subjects include:

• Life Science Organizations: FDA-authored and/or reviewed courses identical to those used by FDA to train its inspectors and investigators;

• Energy Operations: Standardized courses on safety topics and other activities regulated by EPA, OSHA and DOT;

• Environmental, Health and Safety: Curricula focused on workplace subjects, such as employee confidentiality, sexual harassment, site security, and health and safety;

• Ethics, HR and Risk Management: Customized, company-specific courses, including Codes of Conduct, reinforcement of corporate culture, issues related to specific drugs or devices, and regulations from OIG and SEC.

Partial List of Online Courses Available for Purchase

Good Manufacturing Practices (GMP)

• Principles of Good Documentation (PHDV65)
• Orientation to GMP Compliance (PHDV73)
• Introduction to GMPs (PHA38)
• Understanding GMPs for Facilities and Equipment (PHDV63)
• Principles of Auditing (PHDV69)
• A Step-by-Step Approach to Process Validation (PHDV79)

FDA Management

• Basics of Inspections: Beginning an Inspection (FDA38)
• Basics of Inspections: Issues and Observations (FDA39)
• Handling an FDA Inspection (PHDV74)
• Part 11: Electronic Records; Electronic Signatures (FDA31)
• Pre- and Post-Approval FDA Inspections (PHDV66)
• Risk Management: Key Concepts and Definitions (FDA29)

Food Safety

• Basics of HACCP: Overview of HACCP (FDA16)
• Basics of HACCP: Prerequisites Programs and Preliminary Steps (FDA17)
• Basics of HACCP: The Principles (FDA18)
• Employee Hygiene: Food Service (FOOD1)
• Food Microbiological Control 1: Overview of Microbiology (MIC01)
• Food Microbiological Control 4: Foodborne Parasites (MIC05)

Dietary Suppliments

• Dietary Supplements – CGMP Requirements for Quality Control (Dietary05)
• Dietary Supplements – CGMPS for Manufacturing Plants and Equipment (Dietary 03)
• Dietary Supplements – Introduction to Part 111 CGMPs (Dietary02)
• Dietary Supplements – Packaging, Labeling, Holding, and Distribution (Dietary01)
• Dietary Supplements – Production and Process Control System for Manufacturing Operations
• Dietary Supplements – Requirements for Records and Recordkeeping (Dietary06)

Sales & Marketing (Healthcare Compliance)

• Basics of the AdvaMed Code (MDSM01)
• Basics of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (MDSM03)
• Basics of the PhRMA Code (PHSM01)
• Post-Market Reporting of Adverse Drug Reactions (PHSM08)
• Privacy Guidelines for Medical Device Sales Representatives (PRIVACY01)
• Privacy Guidelines for Pharmaceutical Sales Representatives (PRIVACY02)
• Reporting Adverse Events for Medical Devices (MDMS02)

Environmental Health & Safety

• Bloodborne Pathogens — Healthcare Workers (EHS09)
• Hazard Communication (EHS37)
• Introduction to Workplace Safety (EHS53)

Ethics

• Diversity in the Workplace (LAV05)
• Doing the Right Thing for Each Other (ETHICS02)
• Sexual Harassment (RH0016)