BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:64108 DTSTAMP:20260407T213056Z SUMMARY:Webinar on Proactive Internal Auditing-The Key to Establishing , Maintaining, and Improving Quality Systems DESCRIPTION:This webinar provides a broad overview of the internal aud iting functions starting with the concept of quality systems and their objectives, primarily using graphical methods. The webinar focuses on the role of the internal audit function throughout the product lifecy cle. It focuses on the importance of using knowledge to prevent failur e and to improve the quality system.\nThe internal audit is part of a monitoring system that provides Senior Management with the knowledge t o act as needed to maintain and improve the associated quality process es. While  the internal audit is inherent in the device regulations, the internal audit in the pharmaceutical environment has been less str uctured but has become more formalized structured in the FDA 2006 guid ance, The Quality Systems Approach To the Pharmaceutical Good Manufact uring Practices. In 2008, ICH published, ICH Q10, Pharmaceutical  Qua lity Systems, that describes the role of audits in maintaining and imp roving the quality system. The FDA adopted ICH Q10 in 2012.\nThe FDA r egulated industry at all levels fear FDA inspections. The most likely reason for this fear is that deficiencies will be found that require s ignificant actions and time to correct. A proactive internal auditing system providing ongoing communications to management combined with ap propriate management action can relieve these fears and provide greate r confidence.\nMiddle and Senior Management from all functions involve d in establishing and executing corporate strategy and objectives. It is particularly applicable to companies new to the FDA regulated indus try.\nSenior quality management will gain insight on how quality syste ms work and will be able to better understand senior management respon sibilities. Provide knowledge that can be used to persuade others conc erning quality matters.\n \nFinance, Sales and Marketing, Operations, Procurement, and Human Resources who have an active or supporting rol e in Quality.\nOther quality personnel who have the desire and/or pote ntial to advance to quality leadership.\nAreas Covered in the Session :\nDefining and describing the modern quality system and its life-cycl e\nWhat are the objectives of internal auditing?\nDefining the audit p rocess and its cycle\nOrganizing the quality audit functions\nCan a jo b description be written for an internal auditor?\nAuditing Responsibi lities\nin the internal audit is not the same as FDA inspection\nAudit ing may be both subjective and objective\nThe inter-functional audit t eam\nGoing way beyond the audit checklist\nCategorizing findings-CAPA, remediation, or improvement\nThe audit report life-cycle\nInternal Au diting trends\nFDA enforcement of internal audit requirements\n \nWho Will Benefit:\nMiddle and Senior Management\nCompanies new to the FDA regulated industry\nQuality Assurance\nQuality Control\nRegulatory Af fairs\nSenior quality management\nCompliance Director\nVice Presidents \nConsultants\nProject Leaders\nResearch & Development\nSales and Mark eting, Finance & Cost Accounting, and Procurement Departments\nOperati ons Department\nHuman Resources who have an active or supporting role in Quality\nOther quality personnel who have the desire and/or potenti al to advance to quality leadership\n Price Tags:\nLive\nSingle Live : For One Participant\n$ 249\nCorporate Live : For Max. 10 Participant s\n$ 899\n\nFor more information visit https://medtechiq.ning.com/even ts/webinar-on-proactive-internal-auditing-the-key-to-establishing DTSTART;TZID=America/New_York:20140804T130000 DTEND;TZID=America/New_York:20140804T150000 CATEGORIES:webinar LOCATION:Online WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a spx?id=FDB1065 URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx? id=FDB1065 CONTACT:4169154458 ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co mpliancetrainings ATTACH;FMTTYPE="image/jpeg": ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc etrainings:https://medtechiq.ning.com/profile/compliancetrainings END:VEVENT END:VCALENDAR