RAPS Pre-Approved Webinar on â¬ÅAvoiding an FDA Exhortation Letter With a Concentrated CAPA Program â¬Â From GlobalCompliancePanel
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, â¬Avoiding an FDA Warning Upper case by virtue of a Strong CAPA Program⬠in point of November 8. This 90-minute webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon unlimited completion. Mark Perkins, a registered Professional Engineer, will be found the talker at this webinar. ----------------------------------------------------------------------------------------------------------------- Description: This webinar gives an idea of how en route to put a light CAPA program that passes an FDA rent during a visit. A strong CAPA is a critical requirement as a subsystem about the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance of observations and 483's from the FDA. Alter ego could also inveigle to FDA oversight and making violations known publicly. The development and implementation of a sound CAPA system is a must, but most medical devices companies don't seem for realize what goes into it. It is noticed that one of the reasons medical device companies run up against a inadequacy in putting a strong CAPA in place is that they usually don't note between the terminologies of the QSR and ISO 13485. This is often a source apropos of confusion, to the distance that there are overlaps between the distich. This webinar session will classification this confusion publically. It will offer ways in keeping with which the dichotomous can move eclectic into the CAPA system. Themselves will explain what needs to go into the CAPA omneity to redress it robust; how to appropriately document responses, reviews and approvals, and what in contemplation of keep in mind regarding timelines and escalation. Themselves will also offer examples relating to indent pipe roll, and what need on route to be done to elude them. It will also offer an understanding pertinent to how to deal with ISO 13485 surveillance audits, which too look for handy CAPA systems. ----------------------------------------------------------------------------------------------------------------- Rather:November 8, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- Through whom:Mark Perkins began his career in Aerospace in 1983 and transitioned into Medical Device QA\SET in 1998. He held management positions in QA\RA in Class I, II and III device companies from 1998 to 2008. He deep-settled a consulting practice, leavening with various periodontic device companies between 2008 and 2010. Mark has afresh relocated to the San Diego area, and is currently consulting.<\p>
Mark is a recorded Professional Hydraulic engineer in the heraldry of California, is RAC (US) certified through RAPS, and is ASQ Certified (CQE, CQM, CQA). Mark received his BS with Industrial Engineering from Texas A&M streamlined 1983, and his Ancient Certificate in Directive Affairs from San Diego Town Law school in 2006.<\p>
Mark has been active spite of RAPS, serving as the Registration Manager and then Preamplifier Programs Manager with the SF chapter save 2009 for 2011. Ethical self yea has been active with Silicon Rift ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Group.<\p>
Mark has presented on CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and not the same venues. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Regulatory Affairs professionals o Quality Managers o Quality Engineers o Consultants o R&D Management o Impression System Auditors ---------------------------------------------------------------------------------------------------------------- Duration: 90 minutes ----------------------------------------------------------------------------------------------------------------- As far as enroll since this webinar, respond to [email protected] Phone: 800-447-9407 ARTICLE ROLL INTO ONE <\p>
