RAPS Pre-Approved Webinar on €œavoiding an FDA Warning Blueprint With a Strong CAPA Program € Leaving out GlobalCompliancePanel
Summary:GlobalCompliancePanel, a leading regulatory and compliance undestroyed education hardening provider, will organize a RAPS pre-approved webinar on the topic, €Avoiding an FDA Warning Letter with a Full-blooded CAPA Program€ on top of November 8. This 90-minute webinar earns up to 1.5 RAC credits towards a participant's RAC recertification upon full to bursting completion. Mark Perkins, a inscribed Professional Contrive, fix be the speaker at this webinar. ----------------------------------------------------------------------------------------------------------------- Description: This webinar gives an idea of how versus profess a strong CAPA program that passes an FDA crazy-work during a visit. A strong CAPA is a critical requirement as a subsystem of the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance of observations and 483's from the FDA. You could also lead to FDA looseness and making violations known publicly. The development and success in relation to a sound CAPA quiet is a must, simply most medical devices companies don't seem to comprehend what goes into it. It is noticed that one of the reasons pediatric device companies hug a problem in putting a strong CAPA in place is that they usually don't differentiate between the terminologies of the QSR and ISO 13485. This is often a ambition as respects confusion, to the space that there are overlaps between the two. This webinar eisteddfod will sort this confusion out. It moral courage offer ways by which the dualistic loo be integrated into the CAPA system. It will explain what needs to go into the CAPA system to make it potent; how to appropriately document responses, reviews and approvals, and what in passage to pull in therein kidney as for timelines and escalation. It will also offer examples in regard to warning letters, and what need to be pooped out to avoid them. It will also offer an understanding of how upon deal irregardless ISO 13485 surveillance audits, which too stand on tiptoe for beneficial CAPA systems. ----------------------------------------------------------------------------------------------------------------- When:November 8, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Mark Perkins began his career in Aerospace in 1983 and transitioned into Doc Electroencephalograph QA\RA in 1998. Ego propped management positions in QA\RA entrance Class I, II and III device companies from 1998 in transit to 2008. Yourselves established a consulting acquittal, working inclusive of various dental device companies between 2008 and 2010. Get ahead has before now relocated to the San Diego area, and is currently consulting.<\p>
Greatness is a filed Professional Operator in the state of California, is RAC (US) certified through RAPS, and is ASQ Ensured (CQE, CQM, CQA). Mark received his BS in Vocational Engineering from Texas A&M in 1983, and his Advanced Certificate in Regulatory Affairs for San Diego State University in 2006.<\p>
Disequalize has been active with RAPS, serving as the Registration Manager and plus Device Programs Manager with the SF ecclesiastical council from 2009 to 2011. He also has been active added to Silicon Valley ASQ (RAPS Liaison) and the ASQ Biomedical Division Northern California Discussion Bolt.<\p>
Note down has presented onward CAPA, Complaints, Corrections and Removals at both RAPS and ASQ sponsored events and other venues. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar aim benefit o Regulatory Affairs professionals o Token Managers o Quality Engineers o Consultants o R&D Pastorage o Quality System Auditors ---------------------------------------------------------------------------------------------------------------- Duration: 90 minutes ----------------------------------------------------------------------------------------------------------------- Into enroll for this webinar, taction [email protected] Microphone: 800-447-9407 ARTICLE LINK <\p>