U.S. Regulatory Compliance for Manufacturers Training

U.S. Regulatory Compliance for Manufacturers Training by Tonex

Navigating the complex landscape of U.S. regulatory compliance is crucial for manufacturers. This course provides comprehensive insights into FDA, OSHA, EPA, NIST, and UL standards. Understanding cybersecurity regulations, particularly NIST 800-171, is vital for safeguarding sensitive data and maintaining operational integrity. This training empowers manufacturers to achieve compliance, mitigate risks, and ensure product safety.

Audience:

• Manufacturing Engineers
• Quality Assurance Professionals
• Regulatory Affairs Specialists
• Environmental Health and Safety Managers
• Supply Chain Managers
• Cybersecurity Professionals

Learning Objectives:

• Identify key U.S. regulatory agencies and their mandates.
• Apply product compliance standards like RoHS, REACH, and FCC.
• Implement environmental and safety regulations.
• Understand cybersecurity requirements, including NIST 800-171.
• Navigate UL standards for product safety.
• Develop strategies for maintaining ongoing compliance.

Module 1: Introduction to U.S. Regulatory Agencies

• Overview of FDA regulations for medical devices and food.
• Understanding OSHA standards for workplace safety.
• EPA guidelines for environmental protection.
• NIST standards for technology and measurement.
• UL certifications for product safety.
• Interplay between different regulatory bodies.

Module 2: Product Compliance Standards

• RoHS directives for hazardous substances.
• REACH regulations for chemical management.
• FCC rules for electronic devices.
• Labeling and documentation requirements.
• Testing and certification processes.
• Impact of global trade on compliance.

Module 3: Environmental and Safety Regulations

• Air and water pollution control.
• Hazardous waste management.
• Occupational safety and health protocols.
• Emergency response planning.
• Risk assessment and mitigation strategies.
• Sustainability and environmental stewardship.

Module 4: Cybersecurity and NIST 800-171

• Introduction to cybersecurity threats in manufacturing.
• Overview of NIST 800-171 requirements.
• Protecting Controlled Unclassified Information (CUI).
• Implementing security controls and procedures.
• Incident response and recovery planning.
• Auditing and compliance verification.

Module 5: UL Standards for Product Safety

• Understanding UL safety testing and certification.
• Applying UL standards to electrical and electronic products.
• Navigating UL requirements for fire safety.
• Ensuring product safety labeling and documentation.
• Maintaining UL compliance throughout product lifecycle.
• Addressing common UL compliance challenges.

Module 6: Maintaining Ongoing Compliance

• Developing a compliance management system.
• Conducting regular audits and assessments.
• Staying updated on regulatory changes.
• Training and educating employees on compliance.
• Documenting compliance activities.
• Addressing non-compliance issues effectively.

Enroll today to ensure your manufacturing processes meet all U.S. regulatory requirements.