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Benefits of PAI Readiness and Data Integrity for Speedy Approvals (1A)

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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:

  • Understand and anticipate what an FDA investigator will cover during a pre-approval inspection
  • Understand what some of the common inspection issues are that are cited on a 483 at the conclusion of pre-approval inspections
  • Understand how to prepare for a pre-approval inspection
  • Understand the CGMP issues relating to implementation of QbD for manufacturing of drug products and some findings related to QbD for FDA inspections
  • Understand how FDA assesses data integrity and understand some of the recent data integrity issues uncovered during inspections and the resulting regulatory actions
  • Prepare higher-quality facility evaluation applications based on tips learned in this session

Session Agenda 

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

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