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Validity : 17th Dec'24 to 27th Dec'24
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
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 will draw out key developments and key dates (if applicable) with particular emphasis on requirements for US firms.
REACH and RoHS have been referred to as "one of the most complex regulations in the history of the EU." Do not miss this seminar to find out why.
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, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.