The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 22, 2022 from 10am to 1pm
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Event Type: pharma
Organized By: ComplianceOnline
Latest Activity: Jan 28, 2022
This training will evaluate the chief areas of an FDA cGMP compliance 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.
Why Should You Attend:
There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.
And business continues to "shoot itself in the foot", including once highly respected companies. All this affects the Agency's approach to audits and their expectations for companies. They also use GMP compliance audits to drive companies to do much of their work for them. Failure to anticipate, find and correct compliance problems before an FDA site inspection can result in unnecessary 483 Observations, possible Warning Letters, or worst, and a competitive “hit” in the marketplace – all preventable by the effective internal CGMP compliance audit / inspection.
Areas Covered in the Webinar:
Who Will Benefit: