REACH and ROH Overview

REACH and RoHS conformity has banned problematic toxic and environmentally hazardous elements such as lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), and polybrominated diphenyl ether (PBDE) in quantities not exceeding a maximum of 0.1 percent by mass in products.

Restrictions of the use of certain Hazardous Substances (RoHS) and Registration, Evaluation Authorization, and Restriction of Chemical Substances (REACH) are European requirements on chemicals and chemical substances used in products.

REACH is required by the EU for products containing chemical compounds. It is also required by US exporters for all suppliers exporting products to the EU. Even though you may not be an exporter, you may have to still comply with these regulations.

Companies shipping parts or products into Europe must comply with EU REACH and RoHS regulations. EU REACH creates increased risk of product recalls, or bans that must be proactively addressed to ensure continued market access. Products containing harnesses, hydraulic components, rubber, or PVC are at a higher risk of containing restricted materials.

REACH applies to solvents, fragrances, metals, alloys, pigments, dyes, fertilizers, cosmetics, detergents, polymers, electronic equipment, furniture, textile toys, etc

• REACH Registration of Substances
• Introduction to REACH
• Articles and REACH
• Substances of Very High Concerns (SVHC)
• Supply chain communication
• Compliance enforcement
• Basics of RoHS
• Background and content of RoHS
• Responsibility for RoHS
• International requirements of RoHS
• WEEE - background and content of WEEE and how to work to meet requirements
• Material testing methods.
• Overview of three of the most important materials regulations, the processes, and the programs needed
  • RoHS 1 and 2 Compliance
  • REACH Compliance
  • US Dodd-Frank Conflict Minerals Reporting
• Improving data collection by using Jig 101, IEC 62474, IPC 1752
• Managing suppliers with procurement contracts
• Effectively using technology for tracking and managing compliance

This seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your organization can benefit from the mistakes of others. We will review the latest on both directives and draw out key developments and dates (if applicable) with particular emphasis on requirements for US firms.

REACH and RoHS have been called "one of the most complex regulations in the history of the EU." Do not miss this seminar to find out why.

• Manufacturing Professionals
• Anyone new to RoHS and or REACH needs to understand the regulations.
• Anyone responsible for RoHS and REACH compliance.
• Quality Managers
• Environmental Managers
• Purchasers
• Buyers

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.