Conducting Audits Combo

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The Conducting Audits Special Edition brings together information in:

* Audit Focus

* Business Risk Areas

* Planning, Conducting, Follow-up

* Audit Responses

* Auditing Software

The contents include:

Internal Audit Program: Do It Right, or Don't Bother!

Auditing for Business Risks in the World of Regulatory Compliance (Featuring 3 Case Studies)

Internal Audits: Planning, Conducting and Following Up

Approaching the Response to Audit Observations

Auditing Software Development: Five Rules of Thumb

Conducting Audits, GAP Assessments & Corrective Actions

232 pages of valuable information to help you create and maintain your facility's validation programs.

Topics covered include:

Good Manufacturing Practice (GMP) Toolbox
Conducting a 21 CFR Part 11 Electronic Records; Electronic Signatures Gap Assessment
Environmental Control programs: What They Are and What They Should Include
Supplier Qualification Toolbox
Auditing The Training Function
GMP Auditing Techniques for Medical Device Manufacturers: A Case Study
Automation Quality Assurance Planning Guide
Using Gap analysis to identify Systematic Quality Problems
Conducting a Comprehensive Remediation Analysis for part 11 Compliance
What Companies Should Know and consider When Designing a CAPA System, Part I
How to set up a CAPA Program from Scratch: Part II of a Two-Part Article
Conducting an Internal Audit for Electronic Records Compliance: A Primer
Software Supplier Assessment Plan

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