Technical (STED) Files
Schedule:
- 28 October 2008, 1 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: All audits or reviews are confidence-building exercises. The faster you can demonstrate your commitment to quality concepts, ethical manufacturing and a structured and disciplined approach to new product development the faster you build trust and confidence with regulators and notified body technical managers. No one document is more important in such issues then your technical (STED) file. This webinar will be an experienced-based review of such files with useful ideas on:
- Organization and structure
- Format and presentation
- Maintenance
- Effective objective evidence of compliance
- Options for USFDA, Canadian Medical Device Regulations and CE Marking
- Key mandatory documents such as checklists and declarations of conformity
- Selecting harmonized, recognized or performance standards
- Product testing
- Risk Management, and
- Labeling and instructions for use.
Description: The Technical (STED) File is a compilation of information pointing to clear and unambiguous objective evidence your product is safe, will perform as intended as is consistent with claims made during regulatory applications. Your Technical (STED) File will be thoroughly examined during every audit/inspection (in your presence) but what about when your file is submitted to an offsite your review where you will not be present? Make sure your Technical (STED) File can stand alone, be descriptive and clearly demonstrate compliance even when you are not there to answer the evaluator’s questions.
Who should attend: This webinar is ideal for quality managers (whether newly appointed or experienced), regulatory compliance staff and those individuals who have to manage processes, conduct research and development, organize product testing or prepare regulatory applications as well including 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 22 Apr 2008
Registration:
$295
Registration for Oct 28th will
be set up at a later date...
Please Email Us and let us know of your interest in this webinar and we will make sure you are notified immediately when the online registration opens for this event. (Please make sure you note the Webinar and date you are inquiring about in your email)
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
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