Regulatory Affairs/Quality Assurance (RAQA) Tune Up!
Schedule:
- 9 Sept 2008, 1:00 pm Eastern
- 11 December 2008, 1:00 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: What do you get when 37 consultants who have more than 450 years combined experience participate in thousands of inspections/assessments? Hundreds of great ideas, pitfalls to avoid and keen insight on quality management system, product testing and regulatory compliance issues that you can cash in on! Webinar registrants have your pen and paper ready, as we shall review experienced-based useful ideas on:
- Each principal ISO 13485 clause
- Major regulatory requirements such as the USFDA QSR, cGMP, cGLP, Canadian Medical Device Regulations and CE Marking
- Regulatory issues in key growth markets such as Asia/South America
- Product testing
- Technical Files
- Risk Management
- Labeling and instructions for use, and
- Crazy but true instances with auditors/inspectors
After literally thousands of audits/inspections/product testing/clinical trials/design dossier reviews we have pretty much seen it all!
Description: Who does not want: better, faster or less expensive? Head off problems before they arise? Smoother, less stressful regulatory inspections or quality system assessments? The answer is obviously, everyone! This webinar will show you how easy it is to continually improve your product, processes and procedures. Much more than simple compliance, it is great new ideas, updates on regulatory requirements and pitfalls to avoid. This is the one webinar you will attend over and over.
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 7 May 2008
Registration:
$295
Registration for Sept 9th & Dec 11th 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
about in your email)
