There has been a shift in the emphasis of U.S. FDA CGMP compliance inspections (audits). These changes in focus have a major impact on individual company and vendor compliance objectives, efforts, and measurements of success. 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. Poor vendor compliance can result in disruption is the supply chain. And in view of the current pandemic, remote tools and techniques take on increasing importance. Proper conduct, resolution, timelines, and expected documentation. Effective remote/virtual audit techniques.  “Entropy”.

Learning Objectives:-

• Basic U.S. FDA's expectations – the CGMPs; what is the FDA “thinking”
• Avoid complacency from past "good" FDA / Notified Body / ISO audits
• Key pharmaceutical CGMP concerns
• Key medical device CGMP concerns
• Other / associated inspection issues
• Conducting an effective  remote/ virtual site inspection / audit 

Why Should You Attend?

The US FDA expects companies to conduct periodic (yearly) internal CGMP compliance inspections/audits. Companies are also expected to perform an initial CGMP compliance inspection/audit of their vendors, preferably on-site, but there are alternatives.

Content is similar to internal audits and vendor audits. Format changes with remote audits, which will be more common with COVID-19 concerns. This webinar will evaluate the chief areas of such inspections/audits to see actual and anticipated function areas to be audited, as well as changes in regulatory emphasis. Such information will be used to add to the FDA’s inspection “model”, to provide a field-tested approach to a company’s preparation for its own internal and vendor audits, as well as for preparation for a successful US FDA CGMP compliance inspection.QSIT for medical devices and pharmaceutical requirements will be combined to provide an effective, proactive, and aggressive/robust remediation program for any regulated industry. Software, data integrity, and cybersecurity issues. 

The “must-dos” when a notice is received of a pending FDA inspection.

Personnel and staff training for the visit.  Physical facility considerations. 

A “typical” inspection scenario.

Note: This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented).

Who Should Attend?

• Senior management
• R&D
• QA / RA
• Middle management
• Manufacturing
• Operations
• Engineering
• Marketing