Preparing for USFDA Inspections/ Notified Body Audits
Schedule:
- 6 November 2008, 1:00 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: Nothing raises aspirin/antacid consumption and causes sleepless nights like an impending regulatory inspection or notified body audit. But wouldn’t it be great to sit next to your boss during the out briefing and hear praise not non-conformances? You betcha it would… and that is what this presentation is all about!
Webinar registrants have your pen and paper ready, as we shall review experienced-based useful ideas on:
- Maintaining continuing compliance
- Organization and presentation of objective evidence
- Understanding the inspection/assessment’s purpose
- Anticipating inspector/auditor expectations
- Key issues to review/verify
- Staff training and preparation
- Identifying and resolving problems
- How to interact with inspectors/auditors
- Addressing their observations, and lastly
- Crazy but true instances with inspectors/auditors.
After literally thousands of audits/inspections/product testing/clinical trials/design dossier reviews we have pretty much seen it all! How would you explain why your employees keep their cat in the clean room?
Description: Who does not want: better, faster or less expensive? To 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 successfully manage even complex and daunting inspection/audits.
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 20Mar 2008
Registration:
$295
Registration for June 17th 17 June 2008
Registration for Nov 6th 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)
