Conducting Effective Mock FDA Inspections

This webinar will explain the differences between a GMP audit and a mock regulatory inspection, and will highlight the key considerations for effective conduct of a mock inspection, including problems to avoid.

Why Should You Attend:

This webinar will compare GMP audits and mock regulatory inspections, explaining the differences to take into consideration when planning a mock regulatory inspection. The webinar will focus primarily on FDA inspection readiness, but the concepts are applicable regardless of which regulatory venue you are preparing to host.

Areas Covered in the Webinar:

• Comparison of a mock inspection to a standard GMP audit
• Points to consider in planning a mock inspection and selecting the mock inspector
• Goals of a mock inspection versus a standard GMP audit
• Preparing subject matter experts to be interviewed during a mock inspection
• Where to find helpful online resources from the FDA, EMA and other agencies to assist your inspection readiness efforts

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC. His career includes 23 years with the FDA and over 21 years in GMP and GCP consulting worldwide. In his consulting practice, Mr. Chesney helps clients prevent quality and compliance problems through proactive assessment and planning, and when necessary, with remediation planning and health regulatory authority communications.