Environmental Regulations and the effect they will have on Medical Device Manufacturing
Schedule:
- Available for private webinars
Duration: 2 hours with questions and answers
Synopsis: Going green is not just the latest fad and there is a wide spread belief our industry is exempt from these requirements. There are now far-reaching environmental regulations in place that will undoubtedly have an impact on medical device design and manufacturing. This webinar will review US and European environmental requirements and discuss how you can effectively deal with changes that have already or will shortly come into force with insight you can use on:
- California’s Proposition 65
- EU Directives on Reduction of Hazardous Substances (RoHS), Waste Electrical and Electronic Equipment (WEEE), Packaging, EU Energy using Products (EuP) and Registration Evaluation and Assessment of Chemicals (REACH)
- US EPA Toxic Substances Control Act, and
- Asian Initiatives such as China’s Administrative Measure and Japan Green
Description: The most complex regulatory process (medical devices, biotechnology and pharmaceuticals) just got a little more difficult! Regulators from around the world are putting in place tough new environmental requirements that will shake your supplier chain. This webinar will provide an overview of the new regulations and offer some insight into how to evaluate the potential effect they will have on your designs, manufacturing and regulatory approvals.
Who should attend: This webinar is ideal for regulatory compliance staff and R&D staff and those individuals who have to manage processes, conduct research and development, organize product testing or prepare regulatory applications as well as those who must interact with auditors and inspectors.
Presenter: Tim Duggins, Horizon Phoenix’s Senior Partner has more than 25 years experience in medical device quality systems and product testing. Tim is a skilled and fully accredited consultant and auditor with extensive experience implementing fully compliant regulatory and quality systems using EN/ISO 13485, USFDA QSR, Health Canada CMDR and/or all medical European Directives for more than 100 clients. An avidly sought after expert, he served as a consultant to such diverse organizations as federal governments, international non-governmental organizations, and industry from multi-national manufacturers to a three-person niche-market company. Tim has participated on numerous national and international committees writing product testing standards and helping create government regulatory processes; his product experience spans the entire medical device spectrum from high volume injection molded disposable products, digital radiography systems, in vitro diagnostic test kits to implantable cardiovascular devices.
Expert contributor: TBA
Registration:
$295
For more information or to pose a question about this webinar contact: info@raqawebinars.com (Please make sure you note the Webinar and date you are inquiring about in your email)
