BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:This training will evaluate the chief areas of an FDA cGMP com pliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.\n\nWhy Should Yo u Attend:\n\nThere is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a majo r impact on individual compliance objectives\, efforts and measurements o f success.\n\nAnd business continues to "shoot itself in the foot"\, incl uding once highly respected companies. All this affects the Agency's appr oach to audits and their expectations for companies. They also use GMP co mpliance audits to drive companies to do much of their work for them. Fai lure to anticipate\, find and correct compliance problems before an FDA s ite inspection can result in unnecessary 483 Observations\, possible Warn ing Letters\, or worst\, and a competitive “hit” in the marketplace – all preventable by the effective internal CGMP compliance audit / inspection .\n\nDuring this session\, we will evaluate the chief areas of an FDA CGM P compliance audit to see actual and anticipated changes in emphasis base d on this new regulatory climate. This information will be used to add to the FDA’s inspection “model”\, to provide a field-tested approach to a c ompany’s \;internal audit \;program. QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective\, p roactive and aggressive / robust internal audit program for any regulated industry. Software\, data integrity\, and cybersecurity issues. A sugges ted annual time line will be presented. The “must dos” when a notice is r eceived of a pending \;FDA inspection.\n\nThis webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).\n\nAreas Covered in the Webina r:\n\n\nBasic U.S. FDA's expectations – the CGMPs\nThe "target" -- Toughe r FDA Expectations / Requirements\nAvoid complacency from past "good" FDA / Notified Body / ISO audits\nKey medical device and pharmaceutical CGMP concerns\nA risk-based phased approach\nFDA “model” CGMP inspections\nPr ove / maintain 'in control'\nFight “entropy”\n\nFrequently Asked Question s:\n\n\nWhat does the FDA look for in terms of "rework" and "reprocess". When does these terms apply\; especially for labeling and packaging?\nWha t are the common FDA findings for Device History Records?\nWhat is the co mmon inspection plan and recommended frequency for a virtual company?\nWh at is the expectation for virtual companies on how they should manage ven dor quality systems?\nFor audits focused on Material Review Board (MRB) d ue to non-conforming material\, what does the FDA look for during the aud it?\nFor companies who have combination products filed under an NDA\, are they audited against 210/211\, 820\, or both?\nCan you elaborate on P&am p\;PC key issues for verified and validated?\nDo "rework" and "reprocessi ng" term apply to visual inspection and re-packaging of drug product or f inished goods?\n\nWho Will Benefit:\n\n\nSenior and middle management.\nQ uality Assurance\nRegulatory Affairs\nR&\;D\nEngineering\nStaff and Li ne personnel\nSales and Marketing\nOperations / Production\n\n \;\n DTEND:20250304T113000 DTSTAMP:20260513T043848Z DTSTART:20250304T100000 LOCATION:\, SEQUENCE:0 SUMMARY:This training will evaluate the chief areas of an FDA cGMP complia nce audit and help you understand the actual and anticipated changes in e mphasis... UID:4e26a868-a1e6-42a2-a39e-7494bd7e7029 END:VEVENT END:VCALENDAR