Monday, 4 June 2012, 11.00 - 12.15
Moderator: J. David Doleski, Acting Director, Division of Good Manufacturing Practice Assessment, OMPQ, OC, CDER, FDA, USA
FDA's pre-approval inspection program provides FDA with assurance that a manufacturing establishment is capable of manufacturing a drug, and that submitted data are accurate and complete. There are three primary inspectional objectives of this PAI program which include: determine readiness for commercial manufacturing; assess conformance to the application; and perform a data integrity audit.
The session will focus on typical coverage performed during a pre-approval inspection in order to better prepare you for such an inspection. Examples of data integrity issues found during an inspection and FDA's experience with applications utilizing a Quality by Design (QbD) approach will be described.
At the conclusion of this session participants will be able to:
11.00 – 12.15
Benefits of PAI Readiness and Data Integrity for Speedy Approvals
Session Moderator: J. David Doleski, Acting Director, Division of Good Manufacturing Practice Assessment, OMPQ, OC, CDER, FDA
11.00 – 11.30
Inspection Readiness Issues
Roy Sturgeon, President, Lachman Consulting
11.30 – 12.00
Field Inspector Program: What is covered on inspection, QbD, and common issues found during FDA inspections.
Tara Gooen, Senior Regulatory Operations Officer, FDA