Because of the extreme criticality of regulatory audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal 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 improvements are needed. The internal auditor is at the front line in evaluating and assessing the QMS, and ensuring compliance with regulations.
This webinar provides an overview of the techniques necessary in an “audit life cycle and will provide you with the knowledge, understanding, skills and confidence to audit whilst retaining the cooperation and respect of the other personnel.
Areas Covered in the Session :
- Foundation of Internal Auditing
- Audit Process and Methodology
- Internal Auditor Competency and Skills
- Auditor Methods, Techniques and etiquette
- Best practices for conducting and documenting interviews
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Research and Development Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- Logistics Departments
- Production Departments
- Documentation Departments
ICT106
