GMP Chapter Effective Quality Assurance Auditing

Venue: Hilton Garden Inn

Location: Montreal,, Quebec, Canada

Event Date/Time: Apr 14, 2010 End Date/Time: Apr 15, 2010
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two-day "hands on" training course & workshops will address various topics, techniques, tools and methods for auditing including:

Audit Standards
Auditing to U.S. drug (21CFR Part 210/211) and device (21CFR Part 820) good manufacturing practices and the QSR
Auditing to European Union directives
Auditing to ISO Standards
Role Characteristics of the Auditor
Auditing Techniques
The Audit Process
Audit Mechanics
Requirements of the Standard Being Audited
Internal Facility Audits
External Audits
Product, process, procedural and system audits
Auditing Packaging and labeling system
Auditing Laboratory Control System
Evaluate Audit Results
Preparing Audit Reports results
What makes a Good Audit