Effective Internal Audit Process
Schedule:
- 19 August 2008, 1:00 pm Eastern
- 18 November 2008, 1 pm Eastern
Duration: 2 hours with questions and answers
Synopsis: Internal audit is the primary management tool used to ensure the quality management system and manufacturing process complies with regulatory and ISO requirements. Regardless of who inspects you, USFDA, Notified Body or your Quality System Registrar, your internal audit process will be thoroughly examined. Webinar registrants will learn principals and practices to effectively:
- Develop, implement and monitor process-based internal audits
- Prepare your staff for USFDA Inspections or NB Assessments
- Management tools to plan and monitor internal audits
- Verify Corrective or Preventive Action effectiveness, and
- Involve all staff in continuous improvement efforts
Description: Whether you are a three-person niche firm or a billion-dollar multi-national conglomerate, effective internal audit is the single most versatile tool you can use to assess your regulatory compliance. This webinar will provide insight on organizing and managing internal audits drawn from more than 450 years combined experience designing, implementing and managing quality management systems and from participation in countless internal, registration, surveillance audits and regulatory inspections.
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 audits, corrective actions, preventive actions, regulatory inspections, notified body assessments, 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 4 May 2008
Registration:
$295
Registration for Aug 19th & Nov 18th 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)
