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:468608 DTSTAMP:20260527T200313Z SUMMARY:FDA Audit, Quality Assurance Practices, Responsibilities and E xpectations DESCRIPTION:This training will examine the differences between Quality Assurance and Quality Control and the responsibilities of each. In ad dition, attendees will discuss what characteristics quality personnel should possess. The current expectations for an effective quality syst em program as defined in both the FDA and EU requirements and guida nce documents will be reviewed. Topics to be covered will range from the development of a quality manual and procedures, the importance and scope of audits (internal, vendor, third party and regulatory) along with review of various case studies to help further illustrate points discussed.\nThe quality department within companies is responsible for nearly all activities to various degrees that have impact on the qual ity, safety or efficacy of the final product or material produced. It is also responsible for helping assure that contracted services, which is more common today than ever before, are also verified to meet the quality standards set both by the company and the regulatory requireme nts. The training will review special topics of interest to auditors s uch as CAPA programs and investigations that address deviations and  out of specification (OOS) results. Attendees will be given ample op portunity to ask questions, discuss actual case studies and to learn a bout the vast scope of responsibility that the quality system regulati ons expect and the roles of their own positions..\nLearning Objectives :\nUpon completing this course participants should:\n\nUnderstand the regulatory expectations of the quality unit and its role in the Qualit y System Requirements (QSR)\nReview the Quality areas that are the poi nt of focus during regulatory, corporate or third party audits.\nRevie w typical checklist that can be used as a template for the performance of audits\nEvaluate the importance of training, its documentation, an d common concerns being raised over \"operator error\"\nReview the imp ortance and regulatory guidance offered for the investigation of devia tions/out-of-specification results.\nReview the current focus on data integrity issues and the current guidance document regarding it\nRevie w the top 10 most commonly cited drug GMP deficiencies for 2015-2016\n Understand the weaknesses of each person's current quality system and discuss possible recommended corrective actions\n\nWho will Benefit:\n This course is designed for people within the quality unit, those impa cted by quality requirements, third party suppliers who are evaluated against quality issues and their adherence to them, along corporate ma nagement who is required to provide the time and resources to correct quality issues identified. This includes individuals that have Quality Management Systems responsibilities for making general improvements i n their organization's performance. Following personnel will benefit f rom the course:\n\nSenior quality managers\nQuality professionals\nReg ulatory professionals\nCompliance professionals\nProduction supervisor s\nManufacturing engineers\nProduction engineers\nDesign engineers\n\n \nFor more information visit https://medtechiq.ning.com/events/fda-aud it-quality-assurance-practices-responsibilities-and DTSTART;TZID=America/New_York:20210520T090000 DTEND;TZID=America/New_York:20210521T170000 CATEGORIES:seminae LOCATION:online WEBSITE:https://www.complianceonline.com/fda-eu-audit-quality-assuranc e-qsr-seminar-training-80474SEM-prdsm?channel=MedTech%20I.Q URL:https://www.complianceonline.com/fda-eu-audit-quality-assurance-qs r-seminar-training-80474SEM-prdsm?channel=MedTech%20I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/8722268858?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR