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:240310 DTSTAMP:20260410T063311Z SUMMARY:FDA Audit Best Practices - Do's and Don'ts DESCRIPTION:This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory d ocumentation that is so much a part of our regulatory lives, and final ly in the context of this webinar, truthfulness when interacting with FDA inspectors.\nA key component of this webinar is the discussion of the tricks and techniques that inspectors use to elicit information. H ow you react and respond when they occur could impact your results.Oth er key communications skills will be presented in the context of the i nspection and interpersonal exchanges between inspectors and company a ssociates being questioned.Why you should Attend: If you are in any r egulated business - pharmaceuticals, medical devices, you will experie nce an inspection by the U.S. Food and Drug Administration (FDA). Acco rding to the Food, Drug and Cosmetic Act, \"Registered domestic drug e stablishments shall be inspected by the FDA at least once every two ye ars.\" Depending upon the inspection type and the circumstance, inspec tions may occur more frequently.The outcome of those inspections can h ave a grave significant impact upon your business even if you and your colleagues have done everything \"right.\" How you and others behave and interact with FDA inspectors can have an impact on the results rep orted. Interacting with inspectors is not an natural behavior, effecti ve techniques must be learned and mastered if those inspections are to have positive outcomes.Areas Covered in the Session:\n\nImportance of truthfulness\nImportance of knowledgeability and confidence\nFDA Tric ks to elicit information\nArguing and challenging\nBehavior during the inspection\nImportance and role of documentation\nEffective communica tion skills\nBeing deceptive\nOpinion versus fact\nPhrases never to sa y\nHandling adverse findings during the inspection\n\nWho Will Benefit :\n\nThis is an all-inclusive webinar benefiting all individuals withi n the organization but particularly those in positions of management a nd supervision. Vice Presidents, Directors, Associate Directors, Manag ers and Supervisors in ALL functions will benefit from this organizati on. Significantly, compliance and regulatory who spearhead the inspect ions and are responsible for compliance readiness, as well as training that should be building on-going training around this subject should also be included\n\n\n\n\nSpeaker ProfileCharles H. Paul is the Presi dent of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, tra ining, and technical documentation consulting firm - celebrating its t wentieth year in business in 2017. He has been a regulatory and manage ment consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training su bjects. The firm works with both domestic and international clients de signing solutions for complex training and documentation issues.Event link:\nhttps://www.compliance4all.com/webinar/--502846LIVE?channel=%20 medtechiq.ning_2020_SEO\nContact Info\nNetzealous LLC,DBA -Compliance4 all\nEmail: support@compliance4All.com\nPhone: +1-800-447-9407\nWebsit e: https://www.compliance4all.com/\n\n\n\nFor more information visit h ttps://medtechiq.ning.com/events/fda-audit-best-practices-do-s-and-don -ts DTSTART;TZID=America/New_York:20200214T100000 DTEND;TZID=America/New_York:20200214T130000 CATEGORIES:online, event LOCATION:Online WEBSITE:https://www.compliance4all.com/webinar/fda-audit-best-practice s---do's-and-don'ts--502846LIVE URL:https://www.compliance4all.com/webinar/fda-audit-best-practices--- do's-and-don'ts--502846LIVE CONTACT:+1-800-447-9407 ORGANIZER:Compliance4all ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/2647295700?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle ming":https://medtechiq.ning.com/profile/Compliance4all END:VEVENT END:VCALENDAR