Approved suppliers
Schedule:
- Available for private webinars
Duration: 2 hours with questions and answers
Synopsis: If there is one area where companies spend too much time and money it is in the development, translation, printing, modification, re-translation, re-printing and maintenance of labeling and instructions for use. These documents are without a doubt critically important however most companies spend too much time, effort and resources developing, modifying, translating and issuing multiple versions. This webinar cuts to the chase – what is required from regulatory perspective versus what is desirable from the marketing perspective on:
- Product labeling
- Packaging
- Instructions for Use
- Contraindications and warnings
- Translation versus symbols
- Review and maintenance and
- Creating appropriate objective evidence of compliance
Description: The essence of this webinar is focus on what is required versus what is optional for your product labeling, packaging and instructions for use. We point out what is important and what is not integrating this process into design and regulatory efforts. We will also describe objective evidence of compliance that even the most diligent inspectors/auditors will like!
Who should attend: This webinar is ideal for regulatory/quality management staff, research and development teams, inventory or purchasing managers and executives of all types.
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
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