Special Edition

Conducting Audits, Gap Assessments, & Corrective Actions Volume II

In this installment of IVT's Conducting Audits Special Edition Series, both third-party, internal, and regulatory agency inspections are discussed. Supplier management, corrective and preventive actions, FDA inspections, and internal audits are explained through peer-reviewed journal papers, columns, case-studies, and the Business of Auditing and Auditing the Business series from the Journal of GXP Compliance

Table of Contents

Implementing an Effective Provider Qualification Program at the Contract Laboratory
Richard C. Wedlich, Agata E. Libera, Joseph M. Fransen, Eric Sadosky, Matthew T. Therrien, and Kevin J. Webb

The Changing Face of FDA Inspections for Sterile Products
Jeanne Moldenhauer

Laboratory Self Audits
Paul L. Pluta

Internal Audit Preparation-A Key Element of an Effective GXP Training Process
David Markovitz

First Impressions—The Plant Tour
Paul L. Pluta

Implementing Quality Agreements at the Contract Laboratory
Richard C. Wedlich and Kevin J. Webb

Preparation, Preparation, and More Preparation
Ballard Graham, Richard Poska, Robert Ertmann, and Paul L. Pluta

Analysis of Recent Drug GMP Inspections by FDA and AIFA: Different Approaches and Significant Trends
Sofia Cerioni, Ph.D., Raffaele Lasala and Enrica Lombardini

When Quality Needs an Audit
James Kaar and Pat Klemens

Quality is Audited
James Kaar and Pat Klemens

Quality Responds to the Audit
James Kaar and Pat Klemens

The ‘Physics’ of Changing of a Supplier Quality Program
James Kaar and Pat Klemens

The Business of Auditing and Auditing the Business: Part V
James Kaar and Pat Klemens

The Business of Auditing and Auditing the Business: Part VI
James Kaar and Pat Klemens

The Business of Auditing and Auditing the Business: Part VII
James Kaar and Pat Klemens

FDA 483 Responses—Compliance Considerations
Richard Poska and Ballard Graham

An Introduction to Cold Chain Management
Ernest Castiaux

Conducting Valuable Preliminary Investigations
Peter Weichel

Technical Problem Solving
David Ingram

Compliance Case Study #7—Broken Punches in Tablet Compressing
Paul L. Pluta

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