GMP Audits – Tools and Techniques

Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal and external GMP audits in order to find and correct areas where sites are not in full compliance with the GMP regulations before an FDA audit occurs. By providing proper tools and techniques to be used during a GMP audit. The auditor can begin to understand the areas where improvement is needed.

This webinar will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the other personnel.

Areas Covered in the Session :

Principles and Audit Planning

• Planning and preparation
• Audit types and techniques
• Internal vs. external audits
• The audit process

Auditor Skills and Competencies

• What makes a good auditor
• Managing audits

Initiating, Preparing and Conducting the Audit

• Materials management
• Documentation systems
• Pharmaceutical quality systems

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Production Departments
• Logistics Departments
• Manufacturing Departments
• Regulatory and Compliance Departments
• Quality System Auditors
• Consultants