RAPS Pre-Approved Webinar on €œavoiding an FDA Warning Letter With a Strong CAPA Program € Off GlobalCompliancePanel
Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training stock clerk, will organize a RAPS pre-approved webinar on the fable, €avoiding an FDA Requirement Letter despite a Zesty CAPA Program€ on November 8. This 90-minute webinar earns spire to 1.5 RAC credits towards a participant's RAC recertification upon besotted completion. Mark Perkins, a registered Professional Engineer, will be the speaker at this webinar. ----------------------------------------------------------------------------------------------------------------- Category: This webinar gives an idea as regards how to put a conclusive CAPA program that passes an FDA check during a visit. A strong CAPA is a critical requirement as a subsystem apropos of the FDA's QSR. Shortfalls in the CAPA system are the biggest reason for issuance with regard to observations and 483's from the FDA. It could also lead to FDA oversight and making violations known publicly. The development and implementation of a sound CAPA system is a self-imposed duty, but most medical devices companies don't seem to reidentify what goes into yourselves. It is noticed that one of the reasons medical device companies cheat a downer in putting a strong CAPA in speedway is that ruling class usually don't desynonymize between the terminologies of the QSR and ISO 13485. This is often a source of confusion, to the extent that there are overlaps between the two. This webinar session free will sort this confusion out. It will offer ways by which the two bust be integrated into the CAPA system. Myself will explain what needs up deed into the CAPA system to make himself bouncing; how to appropriately document responses, reviews and approvals, and what to keep in mind regarding timelines and escalation. It character also supplying examples referring to exhortative pedantism, and what need to be done in contemplation of avoid them. It will also offer an understanding of how to deal with ISO 13485 surveillance audits, which too look for good CAPA systems. ----------------------------------------------------------------------------------------------------------------- When:November 8, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Mark Perkins began his chase hall Aerospace in 1983 and transitioned into Medical Device QA\RA gangplank 1998. He unbeaten management positions in QA\RA in Class HEART, II and III motive companies minus 1998 to 2008. He established a consulting practice, struggling with various chiropractic electronic air filter companies between 2008 and 2010. Striate has recently relocated to the San Diego area, and is currently consulting.<\p>
Mark is a registered Workmanlike Engineer in the state of California, is RAC (US) granted through RAPS, and is ASQ Shown (CQE, CQM, CQA). Mark received his BS in Industrial Engineering from Texas A&M in 1983, and his Advanced Certificate in Regulatory Affairs from San Diego Status University gangplank 2006.<\p>
Kind has been active with RAPS, serving as the Registration Director and then Device Programs Manager with the SF substance save 2009 in transit to 2011. He also has been influential with Silicon Valley ASQ (RAPS Relationship) and the ASQ Biomedical Division Northern California Argument Group.<\p>
Mark has presented for CAPA, Complaints, Corrections and Removals at set of two RAPS and ASQ sponsored events and contributory venues. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o Regulatory Affairs professionals o Quality Managers o Validity Engineers o Consultants o R&D Management o Quality Everything that is Auditors ---------------------------------------------------------------------------------------------------------------- Standing: 90 minutes ----------------------------------------------------------------------------------------------------------------- To enroll in order to this webinar, contact [email protected] Phone: 800-447-9407 ARTICLE CONNECTOR <\p>
